Trial Outcomes & Findings for Motor Imagery Intervention for Improving Gait and Cognition in the Elderly (NCT NCT02762604)

NCT ID: NCT02762604

Last Updated: 2024-06-04

Results Overview

Change in gait speed (centimeters per second) measured during normal pace walking and walking while talking conditions using an instrumented pathway. A positive mean value is indicative of an improvement (increase) in gait speed post-intervention, whereas a negative mean value is indicative of a decrease in gait speed post-intervention.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

49 participants

Primary outcome timeframe

Baseline and 3 months

Results posted on

2024-06-04

Participant Flow

Randomization goal was 48 but two extra randomization slots were added as a buffer. Once 24 in each condition had been randomized, recruitment stopped, resulting in a total of 49 randomized participants.

Participant milestones

Participant milestones
Measure
Imagined Gait Intervention
During the phone-based imagined gait intervention, participants will be called by the experimenter three times a week and be asked to imagine walking, imagine talking and imagine walking-while-talking. They will also be asked to rate their visual and kinesthetic qualities of their images on a 1-5 scale following each trial. Imagined Gait Intervention: Phone-based imagined gait intervention: participants will be called by the experimenter three times a week and be asked to imagine walking, imagine talking and imagine walking-while-talking. They will also be asked to rate their visual and kinesthetic qualities of their images on a 1-5 scale following each trial.
Visual Imagery Intervention
During the phone-based visual imagery intervention, participants will be called three times a week by the experimenter and be asked to imagine concrete objects (e.g. octopus, teapot, and shovel). They will also be asked to rate their visual qualities of their images on a 1-5 scale following each trial. Visual Imagery Intervention: Phone-based visual imagery intervention: participants will be called three times a week by the experimenter and be asked to imagine concrete objects (e.g. octopus, teapot, and shovel). They will also be asked to rate their visual qualities of their images on a 1-5 scale following each trial.
Overall Study
STARTED
25
24
Overall Study
COMPLETED
22
14
Overall Study
NOT COMPLETED
3
10

Reasons for withdrawal

Reasons for withdrawal
Measure
Imagined Gait Intervention
During the phone-based imagined gait intervention, participants will be called by the experimenter three times a week and be asked to imagine walking, imagine talking and imagine walking-while-talking. They will also be asked to rate their visual and kinesthetic qualities of their images on a 1-5 scale following each trial. Imagined Gait Intervention: Phone-based imagined gait intervention: participants will be called by the experimenter three times a week and be asked to imagine walking, imagine talking and imagine walking-while-talking. They will also be asked to rate their visual and kinesthetic qualities of their images on a 1-5 scale following each trial.
Visual Imagery Intervention
During the phone-based visual imagery intervention, participants will be called three times a week by the experimenter and be asked to imagine concrete objects (e.g. octopus, teapot, and shovel). They will also be asked to rate their visual qualities of their images on a 1-5 scale following each trial. Visual Imagery Intervention: Phone-based visual imagery intervention: participants will be called three times a week by the experimenter and be asked to imagine concrete objects (e.g. octopus, teapot, and shovel). They will also be asked to rate their visual qualities of their images on a 1-5 scale following each trial.
Overall Study
Lost to Follow-up
2
7
Overall Study
Study Suspension due to COVID pandemic
1
3

Baseline Characteristics

Years of education for one participant in the Visual Imagery (VI) Intervention condition was missing

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Imagined Gait Intervention
n=25 Participants
During the phone-based imagined gait intervention, participants will be called by the experimenter three times a week and be asked to imagine walking, imagine talking and imagine walking-while-talking. They will also be asked to rate their visual and kinesthetic qualities of their images on a 1-5 scale following each trial. Imagined Gait Intervention: Phone-based imagined gait intervention: participants will be called by the experimenter three times a week and be asked to imagine walking, imagine talking and imagine walking-while-talking. They will also be asked to rate their visual and kinesthetic qualities of their images on a 1-5 scale following each trial.
Visual Imagery Intervention
n=24 Participants
During the phone-based visual imagery intervention, participants will be called three times a week by the experimenter and be asked to imagine concrete objects (e.g. octopus, teapot, and shovel). They will also be asked to rate their visual qualities of their images on a 1-5 scale following each trial. Visual Imagery Intervention: Phone-based visual imagery intervention: participants will be called three times a week by the experimenter and be asked to imagine concrete objects (e.g. octopus, teapot, and shovel). They will also be asked to rate their visual qualities of their images on a 1-5 scale following each trial.
Total
n=49 Participants
Total of all reporting groups
Age, Continuous
72.92 years
STANDARD_DEVIATION 5.28 • n=25 Participants
72.79 years
STANDARD_DEVIATION 4.84 • n=24 Participants
72.86 years
STANDARD_DEVIATION 5.02 • n=49 Participants
Sex: Female, Male
Female
8 Participants
n=25 Participants
9 Participants
n=24 Participants
17 Participants
n=49 Participants
Sex: Female, Male
Male
17 Participants
n=25 Participants
15 Participants
n=24 Participants
32 Participants
n=49 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants
n=25 Participants
4 Participants
n=24 Participants
6 Participants
n=49 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
20 Participants
n=25 Participants
19 Participants
n=24 Participants
39 Participants
n=49 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
3 Participants
n=25 Participants
1 Participants
n=24 Participants
4 Participants
n=49 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=25 Participants
0 Participants
n=24 Participants
0 Participants
n=49 Participants
Race (NIH/OMB)
Asian
0 Participants
n=25 Participants
0 Participants
n=24 Participants
0 Participants
n=49 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=25 Participants
0 Participants
n=24 Participants
0 Participants
n=49 Participants
Race (NIH/OMB)
Black or African American
10 Participants
n=25 Participants
6 Participants
n=24 Participants
16 Participants
n=49 Participants
Race (NIH/OMB)
White
10 Participants
n=25 Participants
12 Participants
n=24 Participants
22 Participants
n=49 Participants
Race (NIH/OMB)
More than one race
2 Participants
n=25 Participants
4 Participants
n=24 Participants
6 Participants
n=49 Participants
Race (NIH/OMB)
Unknown or Not Reported
3 Participants
n=25 Participants
2 Participants
n=24 Participants
5 Participants
n=49 Participants
Region of Enrollment
United States
25 participants
n=25 Participants
24 participants
n=24 Participants
49 participants
n=49 Participants
Years of Education
15.60 years
STANDARD_DEVIATION 3.06 • n=25 Participants • Years of education for one participant in the Visual Imagery (VI) Intervention condition was missing
16.52 years
STANDARD_DEVIATION 2.95 • n=23 Participants • Years of education for one participant in the Visual Imagery (VI) Intervention condition was missing
16.04 years
STANDARD_DEVIATION 3.01 • n=48 Participants • Years of education for one participant in the Visual Imagery (VI) Intervention condition was missing

PRIMARY outcome

Timeframe: Baseline and 3 months

Population: Overall number of participants analyzed includes all randomized participants with baseline measures. Data was unable to be analyzed for 14 participants in the Visual Imagery group due to a protocol deviation (incorrect intervention procedure).

Change in gait speed (centimeters per second) measured during normal pace walking and walking while talking conditions using an instrumented pathway. A positive mean value is indicative of an improvement (increase) in gait speed post-intervention, whereas a negative mean value is indicative of a decrease in gait speed post-intervention.

Outcome measures

Outcome measures
Measure
Imagined Gait Intervention
n=25 Participants
During the phone-based imagined gait intervention, participants will be called by the experimenter three times a week and be asked to imagine walking, imagine talking and imagine walking-while-talking. They will also be asked to rate their visual and kinesthetic qualities of their images on a 1-5 scale following each trial. Imagined Gait Intervention: Phone-based imagined gait intervention: participants will be called by the experimenter three times a week and be asked to imagine walking, imagine talking and imagine walking-while-talking. They will also be asked to rate their visual and kinesthetic qualities of their images on a 1-5 scale following each trial.
Visual Imagery Intervention
n=10 Participants
During the phone-based visual imagery intervention, participants will be called three times a week by the experimenter and be asked to imagine concrete objects (e.g. octopus, teapot, and shovel). They will also be asked to rate their visual qualities of their images on a 1-5 scale following each trial. Visual Imagery Intervention: Phone-based visual imagery intervention: participants will be called three times a week by the experimenter and be asked to imagine concrete objects (e.g. octopus, teapot, and shovel). They will also be asked to rate their visual qualities of their images on a 1-5 scale following each trial.
Change in Walking Speed During Single and Dual-task Walking Conditions
Gait speed (normal pace)
-3.33 centimeters per second
Standard Deviation 14.13
-0.53 centimeters per second
Standard Deviation 25.77
Change in Walking Speed During Single and Dual-task Walking Conditions
Gait speed (walking-while-talking)
5.89 centimeters per second
Standard Deviation 20.44
-10.55 centimeters per second
Standard Deviation 15.68

SECONDARY outcome

Timeframe: Baseline and 3 months

Population: Overall number of participants analyzed includes all randomized participants with baseline measures. Data was unable to be analyzed for 14 participants in the Visual Imagery group due to a protocol deviation (incorrect intervention procedure). Data was also unable to be analyzed for 2 participants in the Visual Imagery group and 7 participants in the Imagined Gait group due to missing data.

Change in cognitive performance was assessed by the number of correct letters/time (in seconds) generated during walking while talking (WWT). This exercise consists of having the participant walk around a computerized walkway while reciting alternate letters of the alphabet (WWT), starting with the letter "B." A positive mean value reflects an improvement in cognitive performance (increase in the number of correct letters/time generated) post-intervention; whereas, a negative mean value reflects worsening in cognitive performance (decrease in the number of correct letters/time generated) post-intervention.

Outcome measures

Outcome measures
Measure
Imagined Gait Intervention
n=18 Participants
During the phone-based imagined gait intervention, participants will be called by the experimenter three times a week and be asked to imagine walking, imagine talking and imagine walking-while-talking. They will also be asked to rate their visual and kinesthetic qualities of their images on a 1-5 scale following each trial. Imagined Gait Intervention: Phone-based imagined gait intervention: participants will be called by the experimenter three times a week and be asked to imagine walking, imagine talking and imagine walking-while-talking. They will also be asked to rate their visual and kinesthetic qualities of their images on a 1-5 scale following each trial.
Visual Imagery Intervention
n=8 Participants
During the phone-based visual imagery intervention, participants will be called three times a week by the experimenter and be asked to imagine concrete objects (e.g. octopus, teapot, and shovel). They will also be asked to rate their visual qualities of their images on a 1-5 scale following each trial. Visual Imagery Intervention: Phone-based visual imagery intervention: participants will be called three times a week by the experimenter and be asked to imagine concrete objects (e.g. octopus, teapot, and shovel). They will also be asked to rate their visual qualities of their images on a 1-5 scale following each trial.
Change in Cognitive Performance During Walking While Talking
0.19 correct letters/second
Standard Deviation 1.46
-1.54 correct letters/second
Standard Deviation 1.50

SECONDARY outcome

Timeframe: Baseline and 3 months

Population: Overall number of participants analyzed includes all randomized participants with baseline measures. Data was unable to be analyzed for 14 participants in the Visual Imagery group due to a protocol deviation (incorrect intervention procedure). Data was also unable to be analyzed for 2 participants in the Visual Imagery group and 2 participants in the Imagined Gait group due to incomplete tasks/sessions or corrupted data files.

Change in blood-oxygen-level-dependent (BOLD) signal (neuroplasticity) during imagined walking and walking while talking (iWWT) conditions were measured using functional magnetic resonance imaging (fMRI). The mean values reported are changes in factor scores that reflect the overall change in BOLD signal pre- to post-intervention. Positive values reflect an increase in BOLD signal post-intervention, whereas, negative mean values reflect a decrease in BOLD signal post intervention. There are no minimum or maximum values or ranges or thresholds associated with the BOLD measure.

Outcome measures

Outcome measures
Measure
Imagined Gait Intervention
n=23 Participants
During the phone-based imagined gait intervention, participants will be called by the experimenter three times a week and be asked to imagine walking, imagine talking and imagine walking-while-talking. They will also be asked to rate their visual and kinesthetic qualities of their images on a 1-5 scale following each trial. Imagined Gait Intervention: Phone-based imagined gait intervention: participants will be called by the experimenter three times a week and be asked to imagine walking, imagine talking and imagine walking-while-talking. They will also be asked to rate their visual and kinesthetic qualities of their images on a 1-5 scale following each trial.
Visual Imagery Intervention
n=8 Participants
During the phone-based visual imagery intervention, participants will be called three times a week by the experimenter and be asked to imagine concrete objects (e.g. octopus, teapot, and shovel). They will also be asked to rate their visual qualities of their images on a 1-5 scale following each trial. Visual Imagery Intervention: Phone-based visual imagery intervention: participants will be called three times a week by the experimenter and be asked to imagine concrete objects (e.g. octopus, teapot, and shovel). They will also be asked to rate their visual qualities of their images on a 1-5 scale following each trial.
Change in Blood-oxygen-level-dependent (BOLD) Signal During Dual-task Imagined Walking While Talking (iWWT) Conditions
-2.98 Factor score for BOLD signal
Standard Deviation 19.35
-3.07 Factor score for BOLD signal
Standard Deviation 11.89

SECONDARY outcome

Timeframe: Baseline and 3 months

Population: Overall number of participants analyzed includes all randomized participants with baseline measures. Data was unable to be analyzed for 14 participants in the Visual Imagery group due to a protocol deviation (incorrect intervention procedure).

Change in Trail Making Test Form A (TMT-A), is a timed measurement of attention and processing speed. Scoring is based on the time required to complete the task (i.e., drawing a line between 24 consecutive circles randomly arranged on a page) and ranges from 0-300 seconds with shorter time indicating better performance. A negative mean difference reflects an improvement pre to post intervention. The TMT-A uses all numbers (no letters) and includes correction of errors prompted by the examiner.

Outcome measures

Outcome measures
Measure
Imagined Gait Intervention
n=25 Participants
During the phone-based imagined gait intervention, participants will be called by the experimenter three times a week and be asked to imagine walking, imagine talking and imagine walking-while-talking. They will also be asked to rate their visual and kinesthetic qualities of their images on a 1-5 scale following each trial. Imagined Gait Intervention: Phone-based imagined gait intervention: participants will be called by the experimenter three times a week and be asked to imagine walking, imagine talking and imagine walking-while-talking. They will also be asked to rate their visual and kinesthetic qualities of their images on a 1-5 scale following each trial.
Visual Imagery Intervention
n=10 Participants
During the phone-based visual imagery intervention, participants will be called three times a week by the experimenter and be asked to imagine concrete objects (e.g. octopus, teapot, and shovel). They will also be asked to rate their visual qualities of their images on a 1-5 scale following each trial. Visual Imagery Intervention: Phone-based visual imagery intervention: participants will be called three times a week by the experimenter and be asked to imagine concrete objects (e.g. octopus, teapot, and shovel). They will also be asked to rate their visual qualities of their images on a 1-5 scale following each trial.
Change in Trail Making Test Form A
-0.72 seconds
Standard Deviation 19.16
-1.45 seconds
Standard Deviation 5.93

SECONDARY outcome

Timeframe: Baseline and 3 months

Population: Overall number of participants analyzed includes all randomized participants with baseline measures. Data was unable to be analyzed for 14 participants in the Visual Imagery group due to a protocol deviation (incorrect intervention procedure).

Change in Trail Making Test, Form B (TMT-B), is a timed measurement of attention, processing speed, and set-shifting. Scoring is based on the time required to complete the task (i.e., drawing a line between 24 consecutive circles randomly arranged on a page) and ranges from 0-300 seconds with shorter times indicating better performance. A negative mean difference reflects an improvement pre to post intervention. The TMT-B alternates between numbers and letters requiring the participant to switch between numbers and letters in consecutive order and includes correction of errors prompted by the examiner.

Outcome measures

Outcome measures
Measure
Imagined Gait Intervention
n=25 Participants
During the phone-based imagined gait intervention, participants will be called by the experimenter three times a week and be asked to imagine walking, imagine talking and imagine walking-while-talking. They will also be asked to rate their visual and kinesthetic qualities of their images on a 1-5 scale following each trial. Imagined Gait Intervention: Phone-based imagined gait intervention: participants will be called by the experimenter three times a week and be asked to imagine walking, imagine talking and imagine walking-while-talking. They will also be asked to rate their visual and kinesthetic qualities of their images on a 1-5 scale following each trial.
Visual Imagery Intervention
n=10 Participants
During the phone-based visual imagery intervention, participants will be called three times a week by the experimenter and be asked to imagine concrete objects (e.g. octopus, teapot, and shovel). They will also be asked to rate their visual qualities of their images on a 1-5 scale following each trial. Visual Imagery Intervention: Phone-based visual imagery intervention: participants will be called three times a week by the experimenter and be asked to imagine concrete objects (e.g. octopus, teapot, and shovel). They will also be asked to rate their visual qualities of their images on a 1-5 scale following each trial.
Change in Trail Making Test Form B
4.49 seconds
Standard Deviation 54.18
-9.54 seconds
Standard Deviation 19.74

SECONDARY outcome

Timeframe: Baseline and 3 months

Population: Overall number of participants analyzed includes all randomized participants with baseline measures. Data was unable to be analyzed for 14 participants in the Visual Imagery group due to a protocol deviation (incorrect intervention procedure).

Change in Trail Making Test Form B (TMT-B) minus Form A (TMT-A), a timed measure of set-shifting. Scoring is based on the change in time between completing Form B compared to Form A. A negative mean difference reflects an improvement post intervention.

Outcome measures

Outcome measures
Measure
Imagined Gait Intervention
n=25 Participants
During the phone-based imagined gait intervention, participants will be called by the experimenter three times a week and be asked to imagine walking, imagine talking and imagine walking-while-talking. They will also be asked to rate their visual and kinesthetic qualities of their images on a 1-5 scale following each trial. Imagined Gait Intervention: Phone-based imagined gait intervention: participants will be called by the experimenter three times a week and be asked to imagine walking, imagine talking and imagine walking-while-talking. They will also be asked to rate their visual and kinesthetic qualities of their images on a 1-5 scale following each trial.
Visual Imagery Intervention
n=10 Participants
During the phone-based visual imagery intervention, participants will be called three times a week by the experimenter and be asked to imagine concrete objects (e.g. octopus, teapot, and shovel). They will also be asked to rate their visual qualities of their images on a 1-5 scale following each trial. Visual Imagery Intervention: Phone-based visual imagery intervention: participants will be called three times a week by the experimenter and be asked to imagine concrete objects (e.g. octopus, teapot, and shovel). They will also be asked to rate their visual qualities of their images on a 1-5 scale following each trial.
Change in Trail Making Test Form B Minus Form A
5.22 seconds
Standard Deviation 50.28
-8.09 seconds
Standard Deviation 23.09

SECONDARY outcome

Timeframe: Baseline and 3 months

Population: Overall number of participants analyzed includes all randomized participants with baseline measures. Data was unable to be analyzed for 14 participants in the Visual Imagery group due to a protocol deviation (incorrect intervention procedure).

Change in scoring in the letter number sequencing task, a measure of item manipulation, was derived from the letter number sequencing subtest of the working memory domain within the Wechsler Adult Intelligence Scale (WAIS) III battery, a widely used intelligence test for adults. Scoring is based on the number of correctly sequenced letters and numbers with increasing (positive) mean scores indicating an improvement in task performance post intervention. A negative mean score reflects a decrease in task performance post intervention.

Outcome measures

Outcome measures
Measure
Imagined Gait Intervention
n=25 Participants
During the phone-based imagined gait intervention, participants will be called by the experimenter three times a week and be asked to imagine walking, imagine talking and imagine walking-while-talking. They will also be asked to rate their visual and kinesthetic qualities of their images on a 1-5 scale following each trial. Imagined Gait Intervention: Phone-based imagined gait intervention: participants will be called by the experimenter three times a week and be asked to imagine walking, imagine talking and imagine walking-while-talking. They will also be asked to rate their visual and kinesthetic qualities of their images on a 1-5 scale following each trial.
Visual Imagery Intervention
n=10 Participants
During the phone-based visual imagery intervention, participants will be called three times a week by the experimenter and be asked to imagine concrete objects (e.g. octopus, teapot, and shovel). They will also be asked to rate their visual qualities of their images on a 1-5 scale following each trial. Visual Imagery Intervention: Phone-based visual imagery intervention: participants will be called three times a week by the experimenter and be asked to imagine concrete objects (e.g. octopus, teapot, and shovel). They will also be asked to rate their visual qualities of their images on a 1-5 scale following each trial.
Change in Letter Number Sequencing Task Score
-0.55 Correct sequences
Standard Deviation 2.15
0.61 Correct sequences
Standard Deviation 1.84

SECONDARY outcome

Timeframe: Baseline and 3 months

Population: Overall number of participants analyzed includes all randomized participants with baseline measures. Data was unable to be analyzed for 14 participants in the Visual Imagery group due to a protocol deviation (incorrect intervention procedure) and for 1 participant in the Imagined Gait group due to missing data.

Change in Stroop Interference Test: Color-Word (incongruent trials) minus Color (congruent trials) scores were determined. It is a measure of response competition and interference. Scoring is based on the time it takes to read (complete) incongruent trials relative to congruent trials. A negative mean value reflects an improvement in performance after the intervention. A positive mean value reflects an decrease in performance after the intervention.

Outcome measures

Outcome measures
Measure
Imagined Gait Intervention
n=24 Participants
During the phone-based imagined gait intervention, participants will be called by the experimenter three times a week and be asked to imagine walking, imagine talking and imagine walking-while-talking. They will also be asked to rate their visual and kinesthetic qualities of their images on a 1-5 scale following each trial. Imagined Gait Intervention: Phone-based imagined gait intervention: participants will be called by the experimenter three times a week and be asked to imagine walking, imagine talking and imagine walking-while-talking. They will also be asked to rate their visual and kinesthetic qualities of their images on a 1-5 scale following each trial.
Visual Imagery Intervention
n=10 Participants
During the phone-based visual imagery intervention, participants will be called three times a week by the experimenter and be asked to imagine concrete objects (e.g. octopus, teapot, and shovel). They will also be asked to rate their visual qualities of their images on a 1-5 scale following each trial. Visual Imagery Intervention: Phone-based visual imagery intervention: participants will be called three times a week by the experimenter and be asked to imagine concrete objects (e.g. octopus, teapot, and shovel). They will also be asked to rate their visual qualities of their images on a 1-5 scale following each trial.
Change in Stroop Interference Test: Color-Word Minus Color Score
-8.38 seconds
Standard Deviation 30.14
-14.47 seconds
Standard Deviation 31.37

SECONDARY outcome

Timeframe: Baseline and 3 months

Population: Overall number of participants analyzed includes all randomized participants with baseline measures. Data was unable to be analyzed for 14 participants in the Visual Imagery group due to a protocol deviation (incorrect intervention procedure). Data was also unable to be analyzed for 7 participants in the Visual Imagery Group and 13 participants in the Imagined Gait group due to incomplete tasks/sessions or corrupted data files.

Change in the Flanker Interference Task measures how much interference is generated by the presentation of adjacent incongruent and congruent visual information. Scoring is based on the difference in reaction time (in milliseconds) between incongruent and congruent trials responded to correctly. A negative mean is indicative of improved interference post intervention and a positive mean value is indicative of worsening interference post intervention.

Outcome measures

Outcome measures
Measure
Imagined Gait Intervention
n=12 Participants
During the phone-based imagined gait intervention, participants will be called by the experimenter three times a week and be asked to imagine walking, imagine talking and imagine walking-while-talking. They will also be asked to rate their visual and kinesthetic qualities of their images on a 1-5 scale following each trial. Imagined Gait Intervention: Phone-based imagined gait intervention: participants will be called by the experimenter three times a week and be asked to imagine walking, imagine talking and imagine walking-while-talking. They will also be asked to rate their visual and kinesthetic qualities of their images on a 1-5 scale following each trial.
Visual Imagery Intervention
n=3 Participants
During the phone-based visual imagery intervention, participants will be called three times a week by the experimenter and be asked to imagine concrete objects (e.g. octopus, teapot, and shovel). They will also be asked to rate their visual qualities of their images on a 1-5 scale following each trial. Visual Imagery Intervention: Phone-based visual imagery intervention: participants will be called three times a week by the experimenter and be asked to imagine concrete objects (e.g. octopus, teapot, and shovel). They will also be asked to rate their visual qualities of their images on a 1-5 scale following each trial.
Change in Flanker Interference Task
-49.55 milliseconds
Standard Deviation 108.85
-94.69 milliseconds
Standard Deviation 93.97

SECONDARY outcome

Timeframe: Baseline and 3 months

Population: Overall number of participants analyzed includes all randomized participants with baseline measures. Data was unable to be analyzed for 14 participants in the Visual Imagery group due to a protocol deviation (incorrect intervention procedure). Data was also unable to be analyzed for 1 participant in the Visual Imagery group and 6 participants in the Imagined Gait group due to missing data or corrupted data files.

Change in stride length were collected during walking while talking (WWT) conditions on an instrumented walkway. Stride length was defined as the distance between the heel points of 2 consecutive footfalls of the same foot and measured in centimeters (cm).

Outcome measures

Outcome measures
Measure
Imagined Gait Intervention
n=19 Participants
During the phone-based imagined gait intervention, participants will be called by the experimenter three times a week and be asked to imagine walking, imagine talking and imagine walking-while-talking. They will also be asked to rate their visual and kinesthetic qualities of their images on a 1-5 scale following each trial. Imagined Gait Intervention: Phone-based imagined gait intervention: participants will be called by the experimenter three times a week and be asked to imagine walking, imagine talking and imagine walking-while-talking. They will also be asked to rate their visual and kinesthetic qualities of their images on a 1-5 scale following each trial.
Visual Imagery Intervention
n=9 Participants
During the phone-based visual imagery intervention, participants will be called three times a week by the experimenter and be asked to imagine concrete objects (e.g. octopus, teapot, and shovel). They will also be asked to rate their visual qualities of their images on a 1-5 scale following each trial. Visual Imagery Intervention: Phone-based visual imagery intervention: participants will be called three times a week by the experimenter and be asked to imagine concrete objects (e.g. octopus, teapot, and shovel). They will also be asked to rate their visual qualities of their images on a 1-5 scale following each trial.
Change in Stride Length
3.08 centimeters
Standard Deviation 9.33
-11.49 centimeters
Standard Deviation 13.37

SECONDARY outcome

Timeframe: Baseline and 3 months

Population: Overall number of participants analyzed includes all randomized participants with baseline measures. Data was unable to be analyzed for 14 participants in the Visual Imagery group due to a protocol deviation (incorrect intervention procedure). Data was also unable to be analyzed for 1 participant in the Visual Imagery group and 6 participants in the Imagined Gait group due to missing data or corrupted data files.

Change in gait variability is collected during walking while talking on an instrumented walkway. Gait variability, defined as the stride-to-stride fluctuations in walking, was measured by the coefficient of variation (CV) of the mean value of stride-to stride time. CV reflects the level of gait rhythmicity, with lower values indicating greater rhythmicity. A negative mean CV reflects improved (less) variability post intervention whereas a positive mean CV value reflects worse (increased) variability. Stride time CV is closely associated with falls

Outcome measures

Outcome measures
Measure
Imagined Gait Intervention
n=19 Participants
During the phone-based imagined gait intervention, participants will be called by the experimenter three times a week and be asked to imagine walking, imagine talking and imagine walking-while-talking. They will also be asked to rate their visual and kinesthetic qualities of their images on a 1-5 scale following each trial. Imagined Gait Intervention: Phone-based imagined gait intervention: participants will be called by the experimenter three times a week and be asked to imagine walking, imagine talking and imagine walking-while-talking. They will also be asked to rate their visual and kinesthetic qualities of their images on a 1-5 scale following each trial.
Visual Imagery Intervention
n=9 Participants
During the phone-based visual imagery intervention, participants will be called three times a week by the experimenter and be asked to imagine concrete objects (e.g. octopus, teapot, and shovel). They will also be asked to rate their visual qualities of their images on a 1-5 scale following each trial. Visual Imagery Intervention: Phone-based visual imagery intervention: participants will be called three times a week by the experimenter and be asked to imagine concrete objects (e.g. octopus, teapot, and shovel). They will also be asked to rate their visual qualities of their images on a 1-5 scale following each trial.
Change in Gait Variability
-0.17 Coefficient of Variation (CV)
Standard Deviation 2.45
1.81 Coefficient of Variation (CV)
Standard Deviation 1.56

SECONDARY outcome

Timeframe: Baseline and 3 months

Population: Data were unable to be accurately computed for Gait Domain outcome measure due to incomplete data collection of the individual gait variable measurements which would have been summed to generate a Gait Domain Score. Since there was not enough data overall for the models to converge Gait Domain data was not able to be collected.

Change in gait domains (summary measures reported in standard deviation units) derived from factor analysis of quantitative gait variables collected on an instrumented walkway during normal pace walking and walking while talking. Gait domain score is calculated by summing ratings for individual items and dividing by the maximum possible score for the domain, then multiplying by 100. The domain score ranges from 0 to 100, with higher scores reflecting more gait disturbance and lower scores reflecting less gait disturbance.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 3 months

Population: Overall number of participants analyzed includes all randomized participants with baseline measures. Data was unable to be analyzed for 14 participants in the Visual Imagery group due to a protocol deviation (incorrect intervention procedure).

Changes in free recall performance were based on the free cued serial recall test, a measure of verbal learning and memory. Scores range from 0 to 48. Mean values reflect the change in the number of items recalled pre and post intervention. A positive mean value indicates improved recall performance post intervention whereas a negative mean value reflects decreased performance post intervention.

Outcome measures

Outcome measures
Measure
Imagined Gait Intervention
n=25 Participants
During the phone-based imagined gait intervention, participants will be called by the experimenter three times a week and be asked to imagine walking, imagine talking and imagine walking-while-talking. They will also be asked to rate their visual and kinesthetic qualities of their images on a 1-5 scale following each trial. Imagined Gait Intervention: Phone-based imagined gait intervention: participants will be called by the experimenter three times a week and be asked to imagine walking, imagine talking and imagine walking-while-talking. They will also be asked to rate their visual and kinesthetic qualities of their images on a 1-5 scale following each trial.
Visual Imagery Intervention
n=10 Participants
During the phone-based visual imagery intervention, participants will be called three times a week by the experimenter and be asked to imagine concrete objects (e.g. octopus, teapot, and shovel). They will also be asked to rate their visual qualities of their images on a 1-5 scale following each trial. Visual Imagery Intervention: Phone-based visual imagery intervention: participants will be called three times a week by the experimenter and be asked to imagine concrete objects (e.g. octopus, teapot, and shovel). They will also be asked to rate their visual qualities of their images on a 1-5 scale following each trial.
Change in Free Cued Serial Recall Test
1.14 correct items recalled
Standard Deviation 13.01
-1.02 correct items recalled
Standard Deviation 5.81

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 3 months

Population: Overall number of participants analyzed includes all randomized participants with baseline measures. Data was unable to be analyzed for 14 participants in the Visual Imagery group due to a protocol deviation (incorrect intervention procedure).

Change in delayed figure copy recall performance from the RBANS assessment, a measure of spatial learning and memory. Figure copy recall scores range from 0 to 20. A positive mean is indicative of an increase in recall post intervention whereas a negative mean is indicative of a decrease in recall post intervention.

Outcome measures

Outcome measures
Measure
Imagined Gait Intervention
n=25 Participants
During the phone-based imagined gait intervention, participants will be called by the experimenter three times a week and be asked to imagine walking, imagine talking and imagine walking-while-talking. They will also be asked to rate their visual and kinesthetic qualities of their images on a 1-5 scale following each trial. Imagined Gait Intervention: Phone-based imagined gait intervention: participants will be called by the experimenter three times a week and be asked to imagine walking, imagine talking and imagine walking-while-talking. They will also be asked to rate their visual and kinesthetic qualities of their images on a 1-5 scale following each trial.
Visual Imagery Intervention
n=10 Participants
During the phone-based visual imagery intervention, participants will be called three times a week by the experimenter and be asked to imagine concrete objects (e.g. octopus, teapot, and shovel). They will also be asked to rate their visual qualities of their images on a 1-5 scale following each trial. Visual Imagery Intervention: Phone-based visual imagery intervention: participants will be called three times a week by the experimenter and be asked to imagine concrete objects (e.g. octopus, teapot, and shovel). They will also be asked to rate their visual qualities of their images on a 1-5 scale following each trial.
Change in Delayed Figure Copy Recall on Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
0.84 correct items recalled
Standard Deviation 5.83
2.47 correct items recalled
Standard Deviation 5.48

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 3 months

Population: Overall number of participants analyzed includes all randomized participants with baseline measures. Data was unable to be analyzed for 14 participants in the Visual Imagery group due to a protocol deviation (incorrect intervention procedure).

Change in the number of correct words generated on the controlled oral word fluency test, a measure of language processing. Scores range from 0 to 36. A positive mean reflects an improvement in language processing post intervention whereas a negative mean reflects worsening of language processing post intervention

Outcome measures

Outcome measures
Measure
Imagined Gait Intervention
n=25 Participants
During the phone-based imagined gait intervention, participants will be called by the experimenter three times a week and be asked to imagine walking, imagine talking and imagine walking-while-talking. They will also be asked to rate their visual and kinesthetic qualities of their images on a 1-5 scale following each trial. Imagined Gait Intervention: Phone-based imagined gait intervention: participants will be called by the experimenter three times a week and be asked to imagine walking, imagine talking and imagine walking-while-talking. They will also be asked to rate their visual and kinesthetic qualities of their images on a 1-5 scale following each trial.
Visual Imagery Intervention
n=10 Participants
During the phone-based visual imagery intervention, participants will be called three times a week by the experimenter and be asked to imagine concrete objects (e.g. octopus, teapot, and shovel). They will also be asked to rate their visual qualities of their images on a 1-5 scale following each trial. Visual Imagery Intervention: Phone-based visual imagery intervention: participants will be called three times a week by the experimenter and be asked to imagine concrete objects (e.g. octopus, teapot, and shovel). They will also be asked to rate their visual qualities of their images on a 1-5 scale following each trial.
Change in Controlled Oral Word Fluency Test
0.32 correct items generated
Standard Deviation 18.37
2.90 correct items generated
Standard Deviation 11.72

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 3 months

Population: Overall number of participants analyzed includes all randomized participants with baseline measures. Data was unable to be analyzed for 14 participants in the Visual Imagery group due to a protocol deviation (incorrect intervention procedure).

Change in the total number of correct words generated for each category on the semantic fluency test, a measure of language processing. Scores reflect the number of correct items generated in a 60 second window. A positive mean value reflects improved semantic fluency post intervention and a negative mean value reflects worsening of semantic fluency post intervention.

Outcome measures

Outcome measures
Measure
Imagined Gait Intervention
n=25 Participants
During the phone-based imagined gait intervention, participants will be called by the experimenter three times a week and be asked to imagine walking, imagine talking and imagine walking-while-talking. They will also be asked to rate their visual and kinesthetic qualities of their images on a 1-5 scale following each trial. Imagined Gait Intervention: Phone-based imagined gait intervention: participants will be called by the experimenter three times a week and be asked to imagine walking, imagine talking and imagine walking-while-talking. They will also be asked to rate their visual and kinesthetic qualities of their images on a 1-5 scale following each trial.
Visual Imagery Intervention
n=10 Participants
During the phone-based visual imagery intervention, participants will be called three times a week by the experimenter and be asked to imagine concrete objects (e.g. octopus, teapot, and shovel). They will also be asked to rate their visual qualities of their images on a 1-5 scale following each trial. Visual Imagery Intervention: Phone-based visual imagery intervention: participants will be called three times a week by the experimenter and be asked to imagine concrete objects (e.g. octopus, teapot, and shovel). They will also be asked to rate their visual qualities of their images on a 1-5 scale following each trial.
Change in Semantic Fluency Test
3.53 correct words/minute
Standard Deviation 17.04
-4.20 correct words/minute
Standard Deviation 14.18

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 3 months

Population: Overall number of participants analyzed includes all randomized participants with baseline measures. Please note that data was unable to be analyzed for 14 participants in the Visual Imagery group due to a protocol deviation (incorrect intervention procedure). Data was also unable to be analyzed for 1 participant in the Imagined Gait group due to missing data.

Change in number of correct digit symbols generated on the digit symbol substitution test (DSST), a measure of processing speed, attention and working memory. The number of correct symbols within the allowed time in seconds is measured. A positive mean reflects an improvement in the number of correct digit symbols generated post intervention whereas a negative mean value reflects fewer correct digits generated post intervention.

Outcome measures

Outcome measures
Measure
Imagined Gait Intervention
n=24 Participants
During the phone-based imagined gait intervention, participants will be called by the experimenter three times a week and be asked to imagine walking, imagine talking and imagine walking-while-talking. They will also be asked to rate their visual and kinesthetic qualities of their images on a 1-5 scale following each trial. Imagined Gait Intervention: Phone-based imagined gait intervention: participants will be called by the experimenter three times a week and be asked to imagine walking, imagine talking and imagine walking-while-talking. They will also be asked to rate their visual and kinesthetic qualities of their images on a 1-5 scale following each trial.
Visual Imagery Intervention
n=10 Participants
During the phone-based visual imagery intervention, participants will be called three times a week by the experimenter and be asked to imagine concrete objects (e.g. octopus, teapot, and shovel). They will also be asked to rate their visual qualities of their images on a 1-5 scale following each trial. Visual Imagery Intervention: Phone-based visual imagery intervention: participants will be called three times a week by the experimenter and be asked to imagine concrete objects (e.g. octopus, teapot, and shovel). They will also be asked to rate their visual qualities of their images on a 1-5 scale following each trial.
Change in Digit Symbol Substitution
0.11 correct digit symbols
Standard Deviation 20.10
-2.61 correct digit symbols
Standard Deviation 22.26

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Population: SPPB was only administered at baseline (only the balance and chair tests were administered). Change analyses were not performed.

SPPB is a measure of lower extremity function and includes a balance test, a chair stand test and a gait speed test. Because gait speed/velocity was our primary outcome, only administered the balance and chair stand tests were administered. Thus, possible scores range from 0-8 (rather than the typical 0-12) with 0 being worst performance and 8 being best performance.

Outcome measures

Outcome measures
Measure
Imagined Gait Intervention
n=24 Participants
During the phone-based imagined gait intervention, participants will be called by the experimenter three times a week and be asked to imagine walking, imagine talking and imagine walking-while-talking. They will also be asked to rate their visual and kinesthetic qualities of their images on a 1-5 scale following each trial. Imagined Gait Intervention: Phone-based imagined gait intervention: participants will be called by the experimenter three times a week and be asked to imagine walking, imagine talking and imagine walking-while-talking. They will also be asked to rate their visual and kinesthetic qualities of their images on a 1-5 scale following each trial.
Visual Imagery Intervention
n=10 Participants
During the phone-based visual imagery intervention, participants will be called three times a week by the experimenter and be asked to imagine concrete objects (e.g. octopus, teapot, and shovel). They will also be asked to rate their visual qualities of their images on a 1-5 scale following each trial. Visual Imagery Intervention: Phone-based visual imagery intervention: participants will be called three times a week by the experimenter and be asked to imagine concrete objects (e.g. octopus, teapot, and shovel). They will also be asked to rate their visual qualities of their images on a 1-5 scale following each trial.
Modified Short Physical Performance Battery (SPPB) at Baseline
6.79 score on a scale
Standard Deviation 1.17
6.30 score on a scale
Standard Deviation 1.34

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 3 months

Population: Overall number of participants analyzed includes all randomized participants with baseline measures. Data was unable to be analyzed for 14 participants in the Visual Imagery group due to a protocol deviation (incorrect intervention procedure). Data was also unable to be analyzed for 5 participants in the in the Imagined Gait group due to missing data.

Change in mean immediate maze performance (time in seconds), a measure of spatial navigation and memory, were determined. A negative mean value represents an improvement in immediate maze performance post intervention whereas a positive mean value represents worsening of maze performance post intervention.

Outcome measures

Outcome measures
Measure
Imagined Gait Intervention
n=20 Participants
During the phone-based imagined gait intervention, participants will be called by the experimenter three times a week and be asked to imagine walking, imagine talking and imagine walking-while-talking. They will also be asked to rate their visual and kinesthetic qualities of their images on a 1-5 scale following each trial. Imagined Gait Intervention: Phone-based imagined gait intervention: participants will be called by the experimenter three times a week and be asked to imagine walking, imagine talking and imagine walking-while-talking. They will also be asked to rate their visual and kinesthetic qualities of their images on a 1-5 scale following each trial.
Visual Imagery Intervention
n=10 Participants
During the phone-based visual imagery intervention, participants will be called three times a week by the experimenter and be asked to imagine concrete objects (e.g. octopus, teapot, and shovel). They will also be asked to rate their visual qualities of their images on a 1-5 scale following each trial. Visual Imagery Intervention: Phone-based visual imagery intervention: participants will be called three times a week by the experimenter and be asked to imagine concrete objects (e.g. octopus, teapot, and shovel). They will also be asked to rate their visual qualities of their images on a 1-5 scale following each trial.
Change in Immediate Maze Task Performance
9.27 seconds
Standard Deviation 23.21
4.09 seconds
Standard Deviation 6.48

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 3 months

Population: Overall number of participants analyzed includes all randomized participants with baseline measures. Data was unable to be analyzed for 14 participants in the Visual Imagery group due to a protocol deviation (incorrect intervention procedure). Data was also unable to be analyzed for 4 participants in the in the Imagined Gait group due to missing data.

Change in mean delayed maze performance (time in seconds), a measurement of spatial navigation and memory, were determined. A negative mean value represents an improvement in delayed maze performance post intervention, whereas a positive mean performance time represents worsening delayed maze performance post intervention

Outcome measures

Outcome measures
Measure
Imagined Gait Intervention
n=21 Participants
During the phone-based imagined gait intervention, participants will be called by the experimenter three times a week and be asked to imagine walking, imagine talking and imagine walking-while-talking. They will also be asked to rate their visual and kinesthetic qualities of their images on a 1-5 scale following each trial. Imagined Gait Intervention: Phone-based imagined gait intervention: participants will be called by the experimenter three times a week and be asked to imagine walking, imagine talking and imagine walking-while-talking. They will also be asked to rate their visual and kinesthetic qualities of their images on a 1-5 scale following each trial.
Visual Imagery Intervention
n=10 Participants
During the phone-based visual imagery intervention, participants will be called three times a week by the experimenter and be asked to imagine concrete objects (e.g. octopus, teapot, and shovel). They will also be asked to rate their visual qualities of their images on a 1-5 scale following each trial. Visual Imagery Intervention: Phone-based visual imagery intervention: participants will be called three times a week by the experimenter and be asked to imagine concrete objects (e.g. octopus, teapot, and shovel). They will also be asked to rate their visual qualities of their images on a 1-5 scale following each trial.
Change in Delayed Maze Task Performance
7.25 seconds
Standard Deviation 42.07
4.04 seconds
Standard Deviation 5.23

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 3 months

Population: Overall number of participants analyzed includes all randomized participants with baseline measures. Data was unable to be analyzed for 14 participants in the Visual Imagery group due to a protocol deviation (incorrect intervention procedure). Data was also unable to be analyzed for 5 participants in the in the Imagined Gait group due to missing data.

The number of errors during maze performance, a measure of spatial navigation and memory, will be assessed. A negative mean result is indicative of an improvement (fewer errors) post intervention whereas a positive mean result is indicative of a reduction in performance (more errors) post intervention.

Outcome measures

Outcome measures
Measure
Imagined Gait Intervention
n=20 Participants
During the phone-based imagined gait intervention, participants will be called by the experimenter three times a week and be asked to imagine walking, imagine talking and imagine walking-while-talking. They will also be asked to rate their visual and kinesthetic qualities of their images on a 1-5 scale following each trial. Imagined Gait Intervention: Phone-based imagined gait intervention: participants will be called by the experimenter three times a week and be asked to imagine walking, imagine talking and imagine walking-while-talking. They will also be asked to rate their visual and kinesthetic qualities of their images on a 1-5 scale following each trial.
Visual Imagery Intervention
n=10 Participants
During the phone-based visual imagery intervention, participants will be called three times a week by the experimenter and be asked to imagine concrete objects (e.g. octopus, teapot, and shovel). They will also be asked to rate their visual qualities of their images on a 1-5 scale following each trial. Visual Imagery Intervention: Phone-based visual imagery intervention: participants will be called three times a week by the experimenter and be asked to imagine concrete objects (e.g. octopus, teapot, and shovel). They will also be asked to rate their visual qualities of their images on a 1-5 scale following each trial.
Change in Errors on Maze Task
-0.27 errors
Standard Deviation 1.03
0.14 errors
Standard Deviation 0.32

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 3 months

Population: Overall number of participants analyzed includes all randomized participants with baseline measures. Data was unable to be analyzed for 14 participants in the Visual Imagery group due to a protocol deviation (incorrect intervention procedure). Data was also unable to be analyzed for 3 participants in the in the Imagined Gait group and 2 participants in the in the Visual Imagery group due to missing data.

The Geriatric Depression Scale (GDS) will be used to to determine mean changes in depressive symptoms from baseline. Scores range from 0 to 30. Scores of 0 - 9 are considered normal, 10 - 19 indicate mild depression and 20 30 indicate severe depression. As such, higher scores are indicative of more severe depressive symptoms. A positive mean value reflects an increase in depressive symptoms post-intervention whereas a negative value reflects a decrease in depressive symptoms post intervention.

Outcome measures

Outcome measures
Measure
Imagined Gait Intervention
n=22 Participants
During the phone-based imagined gait intervention, participants will be called by the experimenter three times a week and be asked to imagine walking, imagine talking and imagine walking-while-talking. They will also be asked to rate their visual and kinesthetic qualities of their images on a 1-5 scale following each trial. Imagined Gait Intervention: Phone-based imagined gait intervention: participants will be called by the experimenter three times a week and be asked to imagine walking, imagine talking and imagine walking-while-talking. They will also be asked to rate their visual and kinesthetic qualities of their images on a 1-5 scale following each trial.
Visual Imagery Intervention
n=8 Participants
During the phone-based visual imagery intervention, participants will be called three times a week by the experimenter and be asked to imagine concrete objects (e.g. octopus, teapot, and shovel). They will also be asked to rate their visual qualities of their images on a 1-5 scale following each trial. Visual Imagery Intervention: Phone-based visual imagery intervention: participants will be called three times a week by the experimenter and be asked to imagine concrete objects (e.g. octopus, teapot, and shovel). They will also be asked to rate their visual qualities of their images on a 1-5 scale following each trial.
Change in Geriatric Depression Scale
0.11 score on a scale
Standard Deviation 2.30
0.00 score on a scale
Standard Deviation 2.39

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 3 months

Population: Overall number of participants analyzed includes all randomized participants with baseline measures. Data was unable to be analyzed for 14 participants in the Visual Imagery group due to a protocol deviation (incorrect intervention procedure). Data was also unable to be analyzed for 6 participants in the in the Imagined Gait group and 2 participants in the in the Visual Imagery group due to missing data.

Change in symptoms of anxiety. Scores range from 0 to 84 with higher values reflecting more anxiety symptoms. A negative mean reflects a reduction in anxiety symptoms post intervention and a positive mean value reflects an increase in anxiety symptoms post intervention

Outcome measures

Outcome measures
Measure
Imagined Gait Intervention
n=19 Participants
During the phone-based imagined gait intervention, participants will be called by the experimenter three times a week and be asked to imagine walking, imagine talking and imagine walking-while-talking. They will also be asked to rate their visual and kinesthetic qualities of their images on a 1-5 scale following each trial. Imagined Gait Intervention: Phone-based imagined gait intervention: participants will be called by the experimenter three times a week and be asked to imagine walking, imagine talking and imagine walking-while-talking. They will also be asked to rate their visual and kinesthetic qualities of their images on a 1-5 scale following each trial.
Visual Imagery Intervention
n=8 Participants
During the phone-based visual imagery intervention, participants will be called three times a week by the experimenter and be asked to imagine concrete objects (e.g. octopus, teapot, and shovel). They will also be asked to rate their visual qualities of their images on a 1-5 scale following each trial. Visual Imagery Intervention: Phone-based visual imagery intervention: participants will be called three times a week by the experimenter and be asked to imagine concrete objects (e.g. octopus, teapot, and shovel). They will also be asked to rate their visual qualities of their images on a 1-5 scale following each trial.
Change in Beck Anxiety Inventory
0.24 score on a scale
Standard Deviation 1.92
1.00 score on a scale
Standard Deviation 4.16

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 3 months

Population: Overall number of participants analyzed includes all randomized participants with baseline measures. Data was unable to be analyzed for 14 participants in the Visual Imagery group due to a protocol deviation (incorrect intervention procedure). Data was also unable to be analyzed for 2 participants in the in the Visual Imagery group due to missing data.

Change in mean Cortical Thickness obtained from T1-weighted structural images. A positive mean value reflects an increase in cortical thickness post intervention and a negative mean value reflects a decrease in cortical thickness post intervention

Outcome measures

Outcome measures
Measure
Imagined Gait Intervention
n=25 Participants
During the phone-based imagined gait intervention, participants will be called by the experimenter three times a week and be asked to imagine walking, imagine talking and imagine walking-while-talking. They will also be asked to rate their visual and kinesthetic qualities of their images on a 1-5 scale following each trial. Imagined Gait Intervention: Phone-based imagined gait intervention: participants will be called by the experimenter three times a week and be asked to imagine walking, imagine talking and imagine walking-while-talking. They will also be asked to rate their visual and kinesthetic qualities of their images on a 1-5 scale following each trial.
Visual Imagery Intervention
n=8 Participants
During the phone-based visual imagery intervention, participants will be called three times a week by the experimenter and be asked to imagine concrete objects (e.g. octopus, teapot, and shovel). They will also be asked to rate their visual qualities of their images on a 1-5 scale following each trial. Visual Imagery Intervention: Phone-based visual imagery intervention: participants will be called three times a week by the experimenter and be asked to imagine concrete objects (e.g. octopus, teapot, and shovel). They will also be asked to rate their visual qualities of their images on a 1-5 scale following each trial.
Change in Gray Matter Cortical Thickness
-0.03 millimeters
Standard Deviation 0.09
-0.07 millimeters
Standard Deviation 0.03

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 3 months

Population: Results were unable to be computed for White Matter Integrity due to limited data.

Change in White Matter Integrity obtained from diffusion-weighted imaging. Increased white matter integrity is associated with improved cognitive performance whereas decreased white matter integrity is associated with decreased cognitive performance.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 3 months

Population: Results were unable to be computed for White Matter Hyperintensities due to limited data.

Change in White Matter Hyperintensities obtained from Fluid-Attenuated Inversion Recovery imaging. Increased white matter hyperintensities may be indicative of unfavorable outcomes.

Outcome measures

Outcome data not reported

Adverse Events

Imagined Gait Intervention

Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths

Visual Imagery Intervention

Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Imagined Gait Intervention
n=25 participants at risk
During the phone-based imagined gait intervention, participants will be called by the experimenter three times a week and be asked to imagine walking, imagine talking and imagine walking-while-talking. They will also be asked to rate their visual and kinesthetic qualities of their images on a 1-5 scale following each trial. Imagined Gait Intervention: Phone-based imagined gait intervention: participants will be called by the experimenter three times a week and be asked to imagine walking, imagine talking and imagine walking-while-talking. They will also be asked to rate their visual and kinesthetic qualities of their images on a 1-5 scale following each trial.
Visual Imagery Intervention
n=24 participants at risk
During the phone-based visual imagery intervention, participants will be called three times a week by the experimenter and be asked to imagine concrete objects (e.g. octopus, teapot, and shovel). They will also be asked to rate their visual qualities of their images on a 1-5 scale following each trial. Visual Imagery Intervention: Phone-based visual imagery intervention: participants will be called three times a week by the experimenter and be asked to imagine concrete objects (e.g. octopus, teapot, and shovel). They will also be asked to rate their visual qualities of their images on a 1-5 scale following each trial.
Infections and infestations
Pneumonia
0.00%
0/25 • 3 months
Participants were queried weekly about falls and any changes to their health.
4.2%
1/24 • Number of events 1 • 3 months
Participants were queried weekly about falls and any changes to their health.

Other adverse events

Other adverse events
Measure
Imagined Gait Intervention
n=25 participants at risk
During the phone-based imagined gait intervention, participants will be called by the experimenter three times a week and be asked to imagine walking, imagine talking and imagine walking-while-talking. They will also be asked to rate their visual and kinesthetic qualities of their images on a 1-5 scale following each trial. Imagined Gait Intervention: Phone-based imagined gait intervention: participants will be called by the experimenter three times a week and be asked to imagine walking, imagine talking and imagine walking-while-talking. They will also be asked to rate their visual and kinesthetic qualities of their images on a 1-5 scale following each trial.
Visual Imagery Intervention
n=24 participants at risk
During the phone-based visual imagery intervention, participants will be called three times a week by the experimenter and be asked to imagine concrete objects (e.g. octopus, teapot, and shovel). They will also be asked to rate their visual qualities of their images on a 1-5 scale following each trial. Visual Imagery Intervention: Phone-based visual imagery intervention: participants will be called three times a week by the experimenter and be asked to imagine concrete objects (e.g. octopus, teapot, and shovel). They will also be asked to rate their visual qualities of their images on a 1-5 scale following each trial.
Blood and lymphatic system disorders
Anemia
0.00%
0/25 • 3 months
Participants were queried weekly about falls and any changes to their health.
4.2%
1/24 • Number of events 1 • 3 months
Participants were queried weekly about falls and any changes to their health.
Musculoskeletal and connective tissue disorders
Arthritis
0.00%
0/25 • 3 months
Participants were queried weekly about falls and any changes to their health.
8.3%
2/24 • Number of events 2 • 3 months
Participants were queried weekly about falls and any changes to their health.
Ear and labyrinth disorders
Tinnitus
0.00%
0/25 • 3 months
Participants were queried weekly about falls and any changes to their health.
4.2%
1/24 • Number of events 1 • 3 months
Participants were queried weekly about falls and any changes to their health.
Musculoskeletal and connective tissue disorders
Fall
4.0%
1/25 • Number of events 1 • 3 months
Participants were queried weekly about falls and any changes to their health.
8.3%
2/24 • Number of events 2 • 3 months
Participants were queried weekly about falls and any changes to their health.
Musculoskeletal and connective tissue disorders
Back/shoulder pain
12.0%
3/25 • Number of events 5 • 3 months
Participants were queried weekly about falls and any changes to their health.
4.2%
1/24 • Number of events 1 • 3 months
Participants were queried weekly about falls and any changes to their health.
Musculoskeletal and connective tissue disorders
Pain in lower extremities
4.0%
1/25 • Number of events 1 • 3 months
Participants were queried weekly about falls and any changes to their health.
4.2%
1/24 • Number of events 4 • 3 months
Participants were queried weekly about falls and any changes to their health.
Musculoskeletal and connective tissue disorders
Pain in upper extremities
0.00%
0/25 • 3 months
Participants were queried weekly about falls and any changes to their health.
4.2%
1/24 • Number of events 1 • 3 months
Participants were queried weekly about falls and any changes to their health.
Reproductive system and breast disorders
Enlarged prostate
0.00%
0/25 • 3 months
Participants were queried weekly about falls and any changes to their health.
4.2%
1/24 • Number of events 1 • 3 months
Participants were queried weekly about falls and any changes to their health.
Ear and labyrinth disorders
Dizziness
0.00%
0/25 • 3 months
Participants were queried weekly about falls and any changes to their health.
4.2%
1/24 • Number of events 1 • 3 months
Participants were queried weekly about falls and any changes to their health.

Additional Information

Dr. Helena Blumen

Albert Einstein College of Medicine

Phone: 7184303810

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place