Trial Outcomes & Findings for Cognitive Remediation to Improve Mobility in Sedentary Seniors (NCT NCT02567227)
NCT ID: NCT02567227
Last Updated: 2024-02-28
Results Overview
Between group difference in change per arm of gait speed (centimeters/second) measured during normal pace walking and walking while talking conditions using an instrumented walkway (GAITRite® electronic walkway system).
COMPLETED
NA
383 participants
Baseline and 2 months
2024-02-28
Participant Flow
Participant milestones
| Measure |
Cognitive Remediation
An individualized computerized cognitive remediation program.
Cognitive Remediation: This computerized program has successfully been used by seniors in different settings. It trains a number of cognitive processes including attention and Executive Function.The Cognitive Remediation (CREM) training is constructed based on the program's built in baseline cognitive evaluation.
|
Active Control
Individualized computer based exposure and interactive health education classes.
Active Control: Computer, multimedia and group based health education programs.
|
|---|---|---|
|
9 Weeks
STARTED
|
192
|
191
|
|
9 Weeks
COMPLETED
|
158
|
167
|
|
9 Weeks
NOT COMPLETED
|
34
|
24
|
|
6 Month
STARTED
|
158
|
167
|
|
6 Month
COMPLETED
|
113
|
127
|
|
6 Month
NOT COMPLETED
|
45
|
40
|
|
12 Months
STARTED
|
113
|
127
|
|
12 Months
COMPLETED
|
82
|
93
|
|
12 Months
NOT COMPLETED
|
31
|
34
|
Reasons for withdrawal
| Measure |
Cognitive Remediation
An individualized computerized cognitive remediation program.
Cognitive Remediation: This computerized program has successfully been used by seniors in different settings. It trains a number of cognitive processes including attention and Executive Function.The Cognitive Remediation (CREM) training is constructed based on the program's built in baseline cognitive evaluation.
|
Active Control
Individualized computer based exposure and interactive health education classes.
Active Control: Computer, multimedia and group based health education programs.
|
|---|---|---|
|
9 Weeks
Adverse Event
|
5
|
5
|
|
9 Weeks
Withdrawal by Subject
|
18
|
8
|
|
9 Weeks
Study suspended due to COVID-19 pandemic
|
11
|
11
|
|
6 Month
Death
|
2
|
0
|
|
6 Month
Lost to Follow-up
|
43
|
40
|
|
12 Months
Lost to Follow-up
|
31
|
32
|
|
12 Months
Death
|
0
|
2
|
Baseline Characteristics
Cognitive Remediation to Improve Mobility in Sedentary Seniors
Baseline characteristics by cohort
| Measure |
Cognitive Remediation
n=186 Participants
An individualized computerized cognitive remediation program.
Cognitive Remediation: This computerized program has successfully been used by seniors in different settings. It trains a number of cognitive processes including attention and Executive Function.The Cognitive Remediation (CREM) training is constructed based on the program's built in baseline cognitive evaluation.
|
Active Control
n=186 Participants
Individualized computer based exposure and interactive health education classes.
Active Control: Computer, multimedia and group based health education programs.
|
Total
n=372 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
76.94 years
STANDARD_DEVIATION 5.66 • n=5 Participants
|
77.18 years
STANDARD_DEVIATION 5.61 • n=7 Participants
|
77.03 years
STANDARD_DEVIATION 5.61 • n=5 Participants
|
|
Sex: Female, Male
Female
|
135 Participants
n=5 Participants
|
136 Participants
n=7 Participants
|
271 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
51 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
28 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
151 Participants
n=5 Participants
|
142 Participants
n=7 Participants
|
293 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
93 Participants
n=5 Participants
|
90 Participants
n=7 Participants
|
183 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
57 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
28 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
186 participants
n=5 Participants
|
186 participants
n=7 Participants
|
372 participants
n=5 Participants
|
|
Gait Speed, cm/s
|
75.82 centimeters per second
STANDARD_DEVIATION 17.73 • n=5 Participants
|
75.92 centimeters per second
STANDARD_DEVIATION 16.81 • n=7 Participants
|
75.87 centimeters per second
STANDARD_DEVIATION 17.25 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 2 monthsPopulation: Includes all participants who were randomized. Excludes participants diagnosed with dementia post-hoc (n=6 in Experimental; n=5 in Active Comparator).
Between group difference in change per arm of gait speed (centimeters/second) measured during normal pace walking and walking while talking conditions using an instrumented walkway (GAITRite® electronic walkway system).
Outcome measures
| Measure |
Cognitive Remediation
n=186 Participants
An individualized computerized cognitive remediation program.
Cognitive Remediation: This computerized program has successfully been used by seniors in different settings. It trains a number of cognitive processes including attention and Executive Function.The Cognitive Remediation (CREM) training is constructed based on the program's built in baseline cognitive evaluation.
|
Active Control
n=186 Participants
Individualized computer based exposure and interactive health education classes.
Active Control: Computer, multimedia and group based health education programs.
|
|---|---|---|
|
Change in Walking Speed During Single and Dual-task Conditions.
Walking while talking
|
6.02 centimeters per second
Standard Error 1.16
|
5.43 centimeters per second
Standard Error 1.13
|
|
Change in Walking Speed During Single and Dual-task Conditions.
Normal pace walking
|
1.73 centimeters per second
Standard Error 0.94
|
2.76 centimeters per second
Standard Error 0.91
|
SECONDARY outcome
Timeframe: Baseline and 2 monthsPopulation: Includes all participants who were randomized. Excludes participants diagnosed with dementia post-hoc (n=6 in Experimental; n=5 in Active Comparator)
Between group difference in change per arm in mobility measured using the SPPB. The SPPB is comprised of balance, chair rise, and gait speed tests. A score is assigned in each of these three areas (0-4), and summed to obtain an overall summary score (0-12, higher better).
Outcome measures
| Measure |
Cognitive Remediation
n=186 Participants
An individualized computerized cognitive remediation program.
Cognitive Remediation: This computerized program has successfully been used by seniors in different settings. It trains a number of cognitive processes including attention and Executive Function.The Cognitive Remediation (CREM) training is constructed based on the program's built in baseline cognitive evaluation.
|
Active Control
n=186 Participants
Individualized computer based exposure and interactive health education classes.
Active Control: Computer, multimedia and group based health education programs.
|
|---|---|---|
|
Change in Short Physical Performance Battery (SPPB).
|
0.70 score on a scale
Standard Error 0.13
|
0.85 score on a scale
Standard Error 0.12
|
SECONDARY outcome
Timeframe: Baseline and 2 monthsPopulation: Includes all participants who were randomized. Excludes participants diagnosed with dementia post-hoc (n=6 Experimental; n=5 Active Comparator).
Between group difference in change per arm in stride length (cm) collected during normal walking and walking while talking conditions on an instrumented walkway.
Outcome measures
| Measure |
Cognitive Remediation
n=186 Participants
An individualized computerized cognitive remediation program.
Cognitive Remediation: This computerized program has successfully been used by seniors in different settings. It trains a number of cognitive processes including attention and Executive Function.The Cognitive Remediation (CREM) training is constructed based on the program's built in baseline cognitive evaluation.
|
Active Control
n=186 Participants
Individualized computer based exposure and interactive health education classes.
Active Control: Computer, multimedia and group based health education programs.
|
|---|---|---|
|
Stride Length.
Walking while talking stride length
|
3.09 centimeters
Standard Error 1.08
|
2.26 centimeters
Standard Error 1.05
|
|
Stride Length.
Normal walking stride length
|
0.13 centimeters
Standard Error 0.81
|
2.08 centimeters
Standard Error 0.66
|
SECONDARY outcome
Timeframe: Baseline and 2 monthsPopulation: Includes all participants who were randomized. Excludes participants diagnosed with dementia post-hoc (n=6 Experimental; n=5 Active Comparator).
Between group difference in change per arm in gait stride length variability, measured in standard deviation units, collected during normal walking and walking while talking on an instrumented walkway. Gait variability is defined as differences in length from one stride to the next.
Outcome measures
| Measure |
Cognitive Remediation
n=186 Participants
An individualized computerized cognitive remediation program.
Cognitive Remediation: This computerized program has successfully been used by seniors in different settings. It trains a number of cognitive processes including attention and Executive Function.The Cognitive Remediation (CREM) training is constructed based on the program's built in baseline cognitive evaluation.
|
Active Control
n=186 Participants
Individualized computer based exposure and interactive health education classes.
Active Control: Computer, multimedia and group based health education programs.
|
|---|---|---|
|
Gait Variability.
Normal walking gait variability
|
-0.37 standard deviation
Standard Error 0.25
|
-0.13 standard deviation
Standard Error 0.24
|
|
Gait Variability.
Walking while talking gait variability
|
-0.52 standard deviation
Standard Error 0.26
|
-0.08 standard deviation
Standard Error 0.26
|
SECONDARY outcome
Timeframe: Baseline and 2 MonthsPopulation: Includes all participants who were randomized. Excludes participants diagnosed with dementia post-hoc (n=6 Experimental; n=5 Active Comparator).
Between group difference in change per arm in gait domains (summary measures reported as standard deviation units) derived from factor analysis of quantitative gait variables collected on an instrumented walkway during normal walking and walking while talking. Based on previous findings of gait patterns, pace, rhythm and variation factors are defined (using z-scores based on mean and standard deviation at baseline). Higher values are indicative of better performance for pace and rhythm factors and indicative of worse performance for variation factors.
Outcome measures
| Measure |
Cognitive Remediation
n=186 Participants
An individualized computerized cognitive remediation program.
Cognitive Remediation: This computerized program has successfully been used by seniors in different settings. It trains a number of cognitive processes including attention and Executive Function.The Cognitive Remediation (CREM) training is constructed based on the program's built in baseline cognitive evaluation.
|
Active Control
n=186 Participants
Individualized computer based exposure and interactive health education classes.
Active Control: Computer, multimedia and group based health education programs.
|
|---|---|---|
|
Variability in Gait Domains
Normal walking pace
|
0.21 standard deviation
Standard Error 0.14
|
0.37 standard deviation
Standard Error 0.11
|
|
Variability in Gait Domains
Normal walking rhythm
|
0.36 standard deviation
Standard Error 0.12
|
0.25 standard deviation
Standard Error 0.10
|
|
Variability in Gait Domains
Normal walking variation
|
0.07 standard deviation
Standard Error 0.16
|
-0.15 standard deviation
Standard Error 0.13
|
|
Variability in Gait Domains
Walking while talking pace
|
0.75 standard deviation
Standard Error 0.15
|
0.60 standard deviation
Standard Error 0.15
|
|
Variability in Gait Domains
Walking while talking rhythm
|
0.72 standard deviation
Standard Error 0.15
|
0.74 standard deviation
Standard Error 0.19
|
|
Variability in Gait Domains
Walking while talking variation
|
-0.24 standard deviation
Standard Error 0.11
|
-0.22 standard deviation
Standard Error 0.15
|
SECONDARY outcome
Timeframe: Baseline and 2 MonthsPopulation: Includes all participants who were randomized. Excludes participants diagnosed with dementia post-hoc (n=6 Experimental; n=5 Active Comparator) and participants who did not complete the 2 month follow-up assessment (n=34 Experimental; n=24 Active Comparator).
Substantial gait speed improvement is defined as change of ≥1 standard deviation units from baseline performance in gait speed measured during normal walking and walking while talking conditions.
Outcome measures
| Measure |
Cognitive Remediation
n=152 Participants
An individualized computerized cognitive remediation program.
Cognitive Remediation: This computerized program has successfully been used by seniors in different settings. It trains a number of cognitive processes including attention and Executive Function.The Cognitive Remediation (CREM) training is constructed based on the program's built in baseline cognitive evaluation.
|
Active Control
n=162 Participants
Individualized computer based exposure and interactive health education classes.
Active Control: Computer, multimedia and group based health education programs.
|
|---|---|---|
|
Number of Participants With Substantial Gait Speed Change.
Substantial normal walking speed improvement · Improved walking speed ≥1 standard deviation units from baseline
|
10 Participants
|
11 Participants
|
|
Number of Participants With Substantial Gait Speed Change.
Substantial normal walking speed improvement · Did not improve walking speed ≥1 standard deviation units from baseline
|
142 Participants
|
151 Participants
|
|
Number of Participants With Substantial Gait Speed Change.
Substantial walking while talking speed improvement · Improved walking speed ≥1 standard deviation units from baseline
|
23 Participants
|
25 Participants
|
|
Number of Participants With Substantial Gait Speed Change.
Substantial walking while talking speed improvement · Did not improve walking speed ≥1 standard deviation units from baseline
|
129 Participants
|
137 Participants
|
SECONDARY outcome
Timeframe: Baseline and 2 MonthsPopulation: Includes all participants who were randomized. Excludes participants diagnosed with dementia post-hoc (n=6 Experimental; n=5 Active Comparator) and 86 participants (n=43 Experimental; n=43 Active Comparator) with performance inaccuracy \>75%.
Between group difference in change per arm on the Flanker task, a measure of speed of processing, attention and inhibitory control. Scoring is based on reaction time in milliseconds (ms) and calculated as the difference in reaction time that it takes a person, on average, to respond to an incongruent minus congruent stimulus. Lower values reflect better outcome.
Outcome measures
| Measure |
Cognitive Remediation
n=143 Participants
An individualized computerized cognitive remediation program.
Cognitive Remediation: This computerized program has successfully been used by seniors in different settings. It trains a number of cognitive processes including attention and Executive Function.The Cognitive Remediation (CREM) training is constructed based on the program's built in baseline cognitive evaluation.
|
Active Control
n=143 Participants
Individualized computer based exposure and interactive health education classes.
Active Control: Computer, multimedia and group based health education programs.
|
|---|---|---|
|
Flanker Task.
|
-9.05 milliseconds
Standard Error 9.48
|
-1.54 milliseconds
Standard Error 10.55
|
SECONDARY outcome
Timeframe: Baseline and 2 MonthsPopulation: Includes all participants who were randomized. Excludes participants diagnosed with dementia post-hoc (n=6 Experimental; n=5 Active Comparator).
Between group difference in change per arm on the Digit Symbol Substitution Test (a subtest of the Wechsler Adult Intelligence Scale - Revised), a measure of attention, transcription and speed of processing. Scoring is based on the total number of correct responses generated during a 90-sec time interval. Scores range from 0-133 with higher scores indicating better performance.
Outcome measures
| Measure |
Cognitive Remediation
n=186 Participants
An individualized computerized cognitive remediation program.
Cognitive Remediation: This computerized program has successfully been used by seniors in different settings. It trains a number of cognitive processes including attention and Executive Function.The Cognitive Remediation (CREM) training is constructed based on the program's built in baseline cognitive evaluation.
|
Active Control
n=186 Participants
Individualized computer based exposure and interactive health education classes.
Active Control: Computer, multimedia and group based health education programs.
|
|---|---|---|
|
Digit Symbol Substitution Test.
|
2.22 score on a scale
Standard Error 0.48
|
1.21 score on a scale
Standard Error 0.46
|
SECONDARY outcome
Timeframe: Baseline and 2 MonthsPopulation: Includes all participants who were randomized. Excludes participants diagnosed with dementia post-hoc (n=6 Experimental; n=5 Active Comparator).
Between group difference in change per arm on Trail Making Test form A, a timed measure of attention. Scoring is based on the time required to complete the task and on accuracy. Scores range from 0-300 seconds with longer time indicating worse performance. Scores were log transformed prior to analysis.
Outcome measures
| Measure |
Cognitive Remediation
n=186 Participants
An individualized computerized cognitive remediation program.
Cognitive Remediation: This computerized program has successfully been used by seniors in different settings. It trains a number of cognitive processes including attention and Executive Function.The Cognitive Remediation (CREM) training is constructed based on the program's built in baseline cognitive evaluation.
|
Active Control
n=186 Participants
Individualized computer based exposure and interactive health education classes.
Active Control: Computer, multimedia and group based health education programs.
|
|---|---|---|
|
Trail Making Test Form A.
|
-0.06 log (scores on a scale)
Standard Error 0.02
|
-0.07 log (scores on a scale)
Standard Error 0.02
|
SECONDARY outcome
Timeframe: Baseline and 2 MonthsPopulation: Includes all participants who were randomized. Excludes participants diagnosed with dementia post-hoc (n=6 Experimental; n=5 Active Comparator).
Between group difference in change per arm on Trail Making Test form B, a timed measure of attention, set shifting and processing speed. Scoring is based on the time required to complete the task and on accuracy. Scores range from 0-300 seconds with longer time indicating worse performance. Scores were log transformed prior to analysis.
Outcome measures
| Measure |
Cognitive Remediation
n=186 Participants
An individualized computerized cognitive remediation program.
Cognitive Remediation: This computerized program has successfully been used by seniors in different settings. It trains a number of cognitive processes including attention and Executive Function.The Cognitive Remediation (CREM) training is constructed based on the program's built in baseline cognitive evaluation.
|
Active Control
n=186 Participants
Individualized computer based exposure and interactive health education classes.
Active Control: Computer, multimedia and group based health education programs.
|
|---|---|---|
|
Trail Making Test Form B.
|
-0.10 log (scores on a scale)
Standard Error 0.024
|
-0.10 log (scores on a scale)
Standard Error 0.02
|
SECONDARY outcome
Timeframe: Baseline and 2 MonthsPopulation: Includes all participants who were randomized. Excludes participants diagnosed with dementia post-hoc (n=6 Experimental; n=5 Active Comparator).
Between group difference in change per arm on the Controlled Oral Word Association Test, a verbal fluency test that measures word generation performance under specified timed phonemic and semantic conditions. Performance measured by the total number of correct words as well as the number of errors. Scores range from 25-41 seconds with higher scores indicating better performance.
Outcome measures
| Measure |
Cognitive Remediation
n=186 Participants
An individualized computerized cognitive remediation program.
Cognitive Remediation: This computerized program has successfully been used by seniors in different settings. It trains a number of cognitive processes including attention and Executive Function.The Cognitive Remediation (CREM) training is constructed based on the program's built in baseline cognitive evaluation.
|
Active Control
n=186 Participants
Individualized computer based exposure and interactive health education classes.
Active Control: Computer, multimedia and group based health education programs.
|
|---|---|---|
|
Controlled Oral Word Association Test.
|
1.20 score on a scale
Standard Error 0.56
|
0.53 score on a scale
Standard Error 0.54
|
SECONDARY outcome
Timeframe: Baseline and 2 MonthsPopulation: No outcome measure data was collected for this outcome.
Between group difference in change on the Repeatable Battery for the Assessment of Neuropsychological Status, a relatively brief battery that assesses overall level of cognitive function This battery consists of 10 neurocognitive tests measuring memory (immediate and delayed), attention, language, visuospatial abilities and executive functions. Performance is converted to standardized scores derived from a normative sample.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 2 MonthsPopulation: No outcome measure data was collected for this outcome.
Changes in prefrontal activation measure using functional near infra-red spectroscopy.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 6 monthsPopulation: Includes all participants who were randomized. Excludes participants diagnosed with dementia post-hoc (n=6 Experimental; n=5 Active Comparator).
Between group difference in change per arm in gait speed during normal pace and walking while talking conditions measured at six months.
Outcome measures
| Measure |
Cognitive Remediation
n=186 Participants
An individualized computerized cognitive remediation program.
Cognitive Remediation: This computerized program has successfully been used by seniors in different settings. It trains a number of cognitive processes including attention and Executive Function.The Cognitive Remediation (CREM) training is constructed based on the program's built in baseline cognitive evaluation.
|
Active Control
n=186 Participants
Individualized computer based exposure and interactive health education classes.
Active Control: Computer, multimedia and group based health education programs.
|
|---|---|---|
|
Durability
Normal Walking Gait Speed
|
-0.47 centimeters per second
Standard Error 1.03
|
-1.60 centimeters per second
Standard Error 0.97
|
|
Durability
Walking While Talking Gait Speed
|
3.16 centimeters per second
Standard Error 1.30
|
1.77 centimeters per second
Standard Error 1.23
|
SECONDARY outcome
Timeframe: Baseline and 2 MonthsPopulation: Includes all participants who were randomized. Excludes participants diagnosed with dementia post-hoc (n=6 Experimental; n=5 Active Comparator).
Between group difference in change per arm in mobility and balance assessed during stair climbing, which provides a valid assessment tool for predicting disability. Scores are measured as time in seconds to climb 3 stairs with longer time indicating worse performance. Scores were log transformed prior to analysis.
Outcome measures
| Measure |
Cognitive Remediation
n=186 Participants
An individualized computerized cognitive remediation program.
Cognitive Remediation: This computerized program has successfully been used by seniors in different settings. It trains a number of cognitive processes including attention and Executive Function.The Cognitive Remediation (CREM) training is constructed based on the program's built in baseline cognitive evaluation.
|
Active Control
n=186 Participants
Individualized computer based exposure and interactive health education classes.
Active Control: Computer, multimedia and group based health education programs.
|
|---|---|---|
|
Stair Climbing Time.
|
-0.02 log (seconds)
Standard Error 0.03
|
0.01 log (seconds)
Standard Error 0.02
|
SECONDARY outcome
Timeframe: Baseline and 2 MonthsPopulation: Includes all participants who were randomized. Excludes participants diagnosed with dementia post-hoc (n=6 Experimental; n=5 Active Comparator).
Between group difference in change per arm in mobility assessed by activities of daily living tasks on the Activities of Daily Living-Prevention Instrument. Scores range from 0-45 and higher scores indicate poorer function.
Outcome measures
| Measure |
Cognitive Remediation
n=186 Participants
An individualized computerized cognitive remediation program.
Cognitive Remediation: This computerized program has successfully been used by seniors in different settings. It trains a number of cognitive processes including attention and Executive Function.The Cognitive Remediation (CREM) training is constructed based on the program's built in baseline cognitive evaluation.
|
Active Control
n=186 Participants
Individualized computer based exposure and interactive health education classes.
Active Control: Computer, multimedia and group based health education programs.
|
|---|---|---|
|
Disability Scale.
|
-0.18 score on a scale
Standard Error 0.21
|
-0.21 score on a scale
Standard Error 0.24
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 2 monthsPopulation: Includes all participants who were randomized. Excludes participants diagnosed with dementia post-hoc (n=6 Experimental; n=5 Active Comparator).
Between group difference in change per arm in depressive symptoms assessed using the 30 item GDS, scores range from 0 (not depressed) to 30 (depressed).
Outcome measures
| Measure |
Cognitive Remediation
n=186 Participants
An individualized computerized cognitive remediation program.
Cognitive Remediation: This computerized program has successfully been used by seniors in different settings. It trains a number of cognitive processes including attention and Executive Function.The Cognitive Remediation (CREM) training is constructed based on the program's built in baseline cognitive evaluation.
|
Active Control
n=186 Participants
Individualized computer based exposure and interactive health education classes.
Active Control: Computer, multimedia and group based health education programs.
|
|---|---|---|
|
The Geriatric Depression Scale (GDS).
|
0.41 score on a scale
Standard Error 0.26
|
0.15 score on a scale
Standard Error 0.21
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 2 monthsPopulation: Only baseline data was collected on this outcome measure, therefore no data was analyzed.
Between group difference in change per arm in self-esteem assessed using a ten-item Likert-type scale (higher scores are better).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 2 monthsPopulation: Includes all participants who were randomized. Excludes participants diagnosed with dementia post-hoc (n=6 Experimental; n=5 Active Comparator).
Between group difference in change per arm in self-efficacy scores (range 0-100). Higher scores indicate less confidence.
Outcome measures
| Measure |
Cognitive Remediation
n=186 Participants
An individualized computerized cognitive remediation program.
Cognitive Remediation: This computerized program has successfully been used by seniors in different settings. It trains a number of cognitive processes including attention and Executive Function.The Cognitive Remediation (CREM) training is constructed based on the program's built in baseline cognitive evaluation.
|
Active Control
n=186 Participants
Individualized computer based exposure and interactive health education classes.
Active Control: Computer, multimedia and group based health education programs.
|
|---|---|---|
|
Falls Efficacy Scale.
|
0.79 score on a scale
Standard Error 0.69
|
0.40 score on a scale
Standard Error 0.58
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 2 monthsPopulation: Includes all participants who were randomized. Excludes participants diagnosed with dementia post-hoc (n=6 Experimental; n=5 Active Comparator).
Between group difference in change per arm in perceptions of health and quality of life in domains that include social, physical, emotional and mental functions. The SF-12 has 12 items; two component scores capturing perceptions of mental and physical function can be derived. The Physical Component Summary (PCS-12) and Mental Component Summary (MCS-12) scores are calculated using 12 questions with a range of 0-100 (zero indicating the poorest level of health measured and 100 indicating the highest).
Outcome measures
| Measure |
Cognitive Remediation
n=186 Participants
An individualized computerized cognitive remediation program.
Cognitive Remediation: This computerized program has successfully been used by seniors in different settings. It trains a number of cognitive processes including attention and Executive Function.The Cognitive Remediation (CREM) training is constructed based on the program's built in baseline cognitive evaluation.
|
Active Control
n=186 Participants
Individualized computer based exposure and interactive health education classes.
Active Control: Computer, multimedia and group based health education programs.
|
|---|---|---|
|
12-Item Short Form Health Survey (SF-12).
Physical Component Summary
|
0.31 score on a scale
Standard Error 0.45
|
0.52 score on a scale
Standard Error 0.45
|
|
12-Item Short Form Health Survey (SF-12).
Mental Component Summary
|
-0.76 score on a scale
Standard Error 0.50
|
-1.17 score on a scale
Standard Error 0.53
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 12 MonthsPresence and number of falls over 12 months from baseline.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 2 MonthsProgression in cognitive impairment from normal cognitive function at baseline to MCI.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 2 MonthsProgression in cognitive impairment from baseline normal cognitive function to dementia.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 2 MonthsProgression in cognitive impairment from baseline normal cognitive function to MCR.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 2 MonthsProgression in cognitive impairment from baseline normal cognitive function to cognitive impairment defined as presence of incident MCI, dementia, or MCR.
Outcome measures
Outcome data not reported
Adverse Events
Cognitive Remediation
Active Control
Serious adverse events
| Measure |
Cognitive Remediation
n=192 participants at risk
An individualized computerized cognitive remediation program.
Cognitive Remediation: This computerized program has successfully been used by seniors in different settings. It trains a number of cognitive processes including attention and Executive Function.The Cognitive Remediation (CREM) training is constructed based on the program's built in baseline cognitive evaluation.
|
Active Control
n=191 participants at risk
Individualized computer based exposure and interactive health education classes.
Active Control: Computer, multimedia and group based health education programs.
|
|---|---|---|
|
Cardiac disorders
Chest pain
|
1.0%
2/192 • Number of events 2 • 12 months from intervention
Participants were asked if they had any falls or changes in their health at bimonthly phone calls between study visits
|
0.00%
0/191 • 12 months from intervention
Participants were asked if they had any falls or changes in their health at bimonthly phone calls between study visits
|
|
Cardiac disorders
High blood pressure
|
0.52%
1/192 • Number of events 1 • 12 months from intervention
Participants were asked if they had any falls or changes in their health at bimonthly phone calls between study visits
|
0.00%
0/191 • 12 months from intervention
Participants were asked if they had any falls or changes in their health at bimonthly phone calls between study visits
|
|
Musculoskeletal and connective tissue disorders
Leg pain
|
0.52%
1/192 • Number of events 1 • 12 months from intervention
Participants were asked if they had any falls or changes in their health at bimonthly phone calls between study visits
|
0.00%
0/191 • 12 months from intervention
Participants were asked if they had any falls or changes in their health at bimonthly phone calls between study visits
|
|
Musculoskeletal and connective tissue disorders
Fall
|
0.52%
1/192 • Number of events 1 • 12 months from intervention
Participants were asked if they had any falls or changes in their health at bimonthly phone calls between study visits
|
0.52%
1/191 • Number of events 1 • 12 months from intervention
Participants were asked if they had any falls or changes in their health at bimonthly phone calls between study visits
|
Other adverse events
| Measure |
Cognitive Remediation
n=192 participants at risk
An individualized computerized cognitive remediation program.
Cognitive Remediation: This computerized program has successfully been used by seniors in different settings. It trains a number of cognitive processes including attention and Executive Function.The Cognitive Remediation (CREM) training is constructed based on the program's built in baseline cognitive evaluation.
|
Active Control
n=191 participants at risk
Individualized computer based exposure and interactive health education classes.
Active Control: Computer, multimedia and group based health education programs.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Fall
|
17.7%
34/192 • Number of events 41 • 12 months from intervention
Participants were asked if they had any falls or changes in their health at bimonthly phone calls between study visits
|
17.8%
34/191 • Number of events 43 • 12 months from intervention
Participants were asked if they had any falls or changes in their health at bimonthly phone calls between study visits
|
|
Musculoskeletal and connective tissue disorders
Leg pain
|
7.8%
15/192 • Number of events 15 • 12 months from intervention
Participants were asked if they had any falls or changes in their health at bimonthly phone calls between study visits
|
3.7%
7/191 • Number of events 8 • 12 months from intervention
Participants were asked if they had any falls or changes in their health at bimonthly phone calls between study visits
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place