Trial Outcomes & Findings for Independent Walking for Brain Health (NCT NCT03058146)

NCT ID: NCT03058146

Last Updated: 2023-07-17

Results Overview

Average minutes per day spent in moderate to vigorous levels of physical activity (MVPA) (defined as =\>1952 accelerometer counts per minute). MVPA minutes were determined based on one-week of accelerometer wear on the hip at baseline and post intervention.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 53 participants
• Primary outcome timeframe: Pre (baseline) and post (3 months)
• Results posted on: 2023-07-17

Participant Flow

Participants were recruited from ongoing studies at the University of California San Diego and the Shiley-Marcos Alzheimer's Disease Research Center, as well as from ResearchMatch, flyers, community engagement talks (ie, talks at retirement communities, senior centers, libraries, and health fairs) and by word of mouth. All participants were enrolled between October 2017 and March 2020, at which time study recruitment was terminated because of the COVID-19 pandemic.

53 participants were enrolled (signed informed consent). After enrollment, 7 did not meet further eligibility criteria (based on cognitive and fitness testing) and 2 did not complete the baseline sessions due to the COVID-19 shut down. Out of 53 enrolled, 44 were randomized to the exercise (n=21) and control conditions (n=23). One participant randomized to the control condition could not start the intervention due to the COVID-19 shut down. Total analytic sample is N=43 (exercise=21,control=22).

Participant milestones

Measure	Physical Activity Condition Physically inactive older adults in this condition will perform 3 months of prescribed brisk walking (to increase cardio respiratory fitness) in their real world environments, using mobile health (mHealth) devices during each exercise session to achieve and maintain a minimum of 150 minutes of moderate to vigorous physical activity (MVPA) per week.	Healthy Aging Education Condition The education control condition will provide participants with materials and homework assignments on issues related to successful aging, such as nutrition, healthcare, and the typical changes associated with aging.
Overall Study STARTED	21	23
Overall Study COMPLETED	17	21
Overall Study NOT COMPLETED	4	2

Reasons for withdrawal

Measure	Physical Activity Condition Physically inactive older adults in this condition will perform 3 months of prescribed brisk walking (to increase cardio respiratory fitness) in their real world environments, using mobile health (mHealth) devices during each exercise session to achieve and maintain a minimum of 150 minutes of moderate to vigorous physical activity (MVPA) per week.	Healthy Aging Education Condition The education control condition will provide participants with materials and homework assignments on issues related to successful aging, such as nutrition, healthcare, and the typical changes associated with aging.
Overall Study Withdrawal by Subject	4	1
Overall Study Coronavirus (COVID)-19 shutdown	0	1

Baseline Characteristics

Independent Walking for Brain Health

Baseline characteristics by cohort

Measure	Physical Activity Condition n=21 Participants Physically inactive older adults in this condition will perform 3 months of prescribed brisk walking (to increase cardio respiratory fitness) in their real world environments, using mobile health (mHealth) devices during each exercise session to achieve and maintain a minimum of 150 minutes of moderate to vigorous physical activity (MVPA) per week.	Healthy Aging Education Condition n=22 Participants The education control condition will provide participants with materials and homework assignments on issues related to successful aging, such as nutrition, healthcare, and the typical changes associated with aging.	Total n=43 Participants Total of all reporting groups
Age, Continuous	71.24 years STANDARD_DEVIATION 4.27 • n=5 Participants	72.27 years STANDARD_DEVIATION 4.14 • n=7 Participants	71.77 years STANDARD_DEVIATION 4.19 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	16 Participants n=7 Participants	32 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=5 Participants	21 Participants n=7 Participants	37 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	0 Participants n=7 Participants	3 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	2 Participants n=5 Participants	0 Participants n=7 Participants	2 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	18 Participants n=5 Participants	22 Participants n=7 Participants	40 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	21 participants n=5 Participants	22 participants n=7 Participants	43 participants n=5 Participants
Baseline MVPA	26.37 Average MVPA minutes per day STANDARD_DEVIATION 17.31 • n=5 Participants	21.32 Average MVPA minutes per day STANDARD_DEVIATION 17.42 • n=7 Participants	23.8 Average MVPA minutes per day STANDARD_DEVIATION 17.36 • n=5 Participants

PRIMARY outcome

Timeframe: Pre (baseline) and post (3 months)

Population: All participants who were randomized and completed the baseline sessions were included in the analyses (N=43).

Average minutes per day spent in moderate to vigorous levels of physical activity (MVPA) (defined as =>1952 accelerometer counts per minute). MVPA minutes were determined based on one-week of accelerometer wear on the hip at baseline and post intervention.

Outcome measures

Measure	Physical Activity Condition n=21 Participants Physically inactive older adults in this condition will perform 3 months of prescribed brisk walking (to increase cardio respiratory fitness) in their real world environments, using mobile health (mHealth) devices during each exercise session to achieve and maintain a minimum of 150 minutes of moderate to vigorous physical activity (MVPA) per week.	Healthy Aging Education Condition n=22 Participants The education control condition will provide participants with materials and homework assignments on issues related to successful aging, such as nutrition, healthcare, and the typical changes associated with aging.
Moderate to Vigorous Physical Activity (MVPA) Average Per Day Pre MVPA average minutes per day	26.37 average minutes per day Standard Deviation 17.31	21.34 average minutes per day Standard Deviation 17.44
Moderate to Vigorous Physical Activity (MVPA) Average Per Day Post MVPA average minutes per day	44.09 average minutes per day Standard Deviation 25.28	25.28 average minutes per day Standard Deviation 15.99

SECONDARY outcome

Timeframe: Pre (baseline) and post (3 months)

Population: We provide descriptive statistics for pre and post cerebral blood flow in the hippocampus and frontal cortex.

Average cerebral blood flow measured with arterial spin labeling magnetic resonance imaging in ml/100g/min. Cerebral blood flow was obtained via arterial spin labeling MRI and Freesurfer software was utilized to delineate regions of interest for each participant (right and left regions were averaged). For the frontal lobe cerebral blood flow we averaged the mean of superior frontal, rostral and caudal middle frontal, pars opercularis, pars triangularis, pars orbitalis, lateral and medial orbitofrontal, precentral, paracentral, and frontal pole.

Outcome measures

Measure	Physical Activity Condition n=21 Participants Physically inactive older adults in this condition will perform 3 months of prescribed brisk walking (to increase cardio respiratory fitness) in their real world environments, using mobile health (mHealth) devices during each exercise session to achieve and maintain a minimum of 150 minutes of moderate to vigorous physical activity (MVPA) per week.	Healthy Aging Education Condition n=22 Participants The education control condition will provide participants with materials and homework assignments on issues related to successful aging, such as nutrition, healthcare, and the typical changes associated with aging.
Cerebral Blood Flow (Hippocampal and Frontal) Pre hippocampal cerebral blood flow	40.4 ml/100g/minute Standard Deviation 10.82	41.03 ml/100g/minute Standard Deviation 12.24
Cerebral Blood Flow (Hippocampal and Frontal) Post hippocampal cerebral blood flow	35.36 ml/100g/minute Standard Deviation 5.56	40.99 ml/100g/minute Standard Deviation 9.1
Cerebral Blood Flow (Hippocampal and Frontal) Post frontal cerebral blood flow	41.31 ml/100g/minute Standard Deviation 7.41	46.96 ml/100g/minute Standard Deviation 10.7
Cerebral Blood Flow (Hippocampal and Frontal) Pre frontal cerebral blood flow	45.52 ml/100g/minute Standard Deviation 11.58	47.24 ml/100g/minute Standard Deviation 10.46

OTHER_PRE_SPECIFIED outcome

Timeframe: Pre (baseline) and post (3 months)

Population: All participants completed neuropsychological testing at pre and post.

A memory composite score was created by converting raw scores into z-scores and then averaging them for the following tests: Rey Auditory Verbal Learning Test trials 1 to 5, trial 6 (short-delay free recall), and delayed recall; Wechsler Memory Scale - Revised Logical Memory I and II (immediate and delayed recall scores). Z-scores were calculated using raw scores for these tests in the entire sample [(raw score-mean of the sample)/standard deviation of the sample]. Z-scores of 0 represent the sample's mean performance on the tests, z-scores >0 indicate better performance compared to the sample's mean, while z-scores <0 indicate worse performance compared to the sample's mean.

Outcome measures

Measure	Physical Activity Condition n=21 Participants Physically inactive older adults in this condition will perform 3 months of prescribed brisk walking (to increase cardio respiratory fitness) in their real world environments, using mobile health (mHealth) devices during each exercise session to achieve and maintain a minimum of 150 minutes of moderate to vigorous physical activity (MVPA) per week.	Healthy Aging Education Condition n=22 Participants The education control condition will provide participants with materials and homework assignments on issues related to successful aging, such as nutrition, healthcare, and the typical changes associated with aging.
Memory Function Pre memory score	.08 z-score Standard Deviation .8	-.07 z-score Standard Deviation .82
Memory Function Post memory score	-.10 z-score Standard Deviation .94	.09 z-score Standard Deviation .68

OTHER_PRE_SPECIFIED outcome

Timeframe: Pre (baseline) and post (3 months)

Population: All participants were included and descriptive statistics are presented for pre and post.

An executive function composite score was created by converting raw scores into z-scores and then averaging them for the following tests: Trail Making Test Part B minus Trail Making Test Part A, Golden version of the Stroop Color Word Trial, and verbal fluency (letters F,A,S). Trail making test scores were reversed prior to averaging, so higher scores = better performance. Z-scores were calculated using raw scores for these tests in the entire sample [(raw score-mean of the sample)/standard deviation of the sample]. Z-scores of 0 represent the sample's mean performance on the tests, z-scores >0 indicate better performance compared to the sample's mean, while z-scores <0 indicate worse performance compared to the sample's mean.

Outcome measures

Measure	Physical Activity Condition n=21 Participants Physically inactive older adults in this condition will perform 3 months of prescribed brisk walking (to increase cardio respiratory fitness) in their real world environments, using mobile health (mHealth) devices during each exercise session to achieve and maintain a minimum of 150 minutes of moderate to vigorous physical activity (MVPA) per week.	Healthy Aging Education Condition n=22 Participants The education control condition will provide participants with materials and homework assignments on issues related to successful aging, such as nutrition, healthcare, and the typical changes associated with aging.
Executive Function Pre executive function score	.15 z-score Standard Deviation .69	-.14 z-score Standard Deviation .80
Executive Function Post executive function score	.07 z-score Standard Deviation .73	-.06 z-score Standard Deviation .84

OTHER_PRE_SPECIFIED outcome

Timeframe: Pre (baseline) and post (3 months)

Population: Descriptive data are presented for pre and post.

Total time it takes the participant to reach 85% of their estimated maximal heart rate (220-age) measured via sub-maximal treadmill test in seconds.

Outcome measures

Measure	Physical Activity Condition n=21 Participants Physically inactive older adults in this condition will perform 3 months of prescribed brisk walking (to increase cardio respiratory fitness) in their real world environments, using mobile health (mHealth) devices during each exercise session to achieve and maintain a minimum of 150 minutes of moderate to vigorous physical activity (MVPA) per week.	Healthy Aging Education Condition n=22 Participants The education control condition will provide participants with materials and homework assignments on issues related to successful aging, such as nutrition, healthcare, and the typical changes associated with aging.
Cardiorespiratory Fitness Pre cardiorespiratory fitness (seconds)	873.48 seconds Standard Deviation 175.47	840.55 seconds Standard Deviation 277.62
Cardiorespiratory Fitness Post cardiorespiratory fitness (seconds)	995.71 seconds Standard Deviation 157.43	948.61 seconds Standard Deviation 172.52

Adverse Events

Physical Activity Condition

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Healthy Aging Education Condition

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Physical Activity Condition n=21 participants at risk Physically inactive older adults in this condition will perform 3 months of prescribed brisk walking (to increase cardio respiratory fitness) in their real world environments, using mobile health (mHealth) devices during each exercise session to achieve and maintain a minimum of 150 minutes of moderate to vigorous physical activity (MVPA) per week.	Healthy Aging Education Condition n=22 participants at risk The education control condition will provide participants with materials and homework assignments on issues related to successful aging, such as nutrition, healthcare, and the typical changes associated with aging.
Renal and urinary disorders Non serious adverse event	4.8% 1/21 • Number of events 1 • 12 weeks Adverse events recording followed the National Institute on Aging (NIA) Adverse Event and Serious Adverse Event Guidelines as outlined by the study's Data and Safety Monitoring Plan (DSMP), which included a safety officer. All adverse events were carefully monitored via telephone contact throughout the trial and were reported to the Institutional Review Board (IRB) of the University of California, San Diego, and the NIA program official following National Institutes of Health (NIH) guidelines.	0.00% 0/22 • 12 weeks Adverse events recording followed the National Institute on Aging (NIA) Adverse Event and Serious Adverse Event Guidelines as outlined by the study's Data and Safety Monitoring Plan (DSMP), which included a safety officer. All adverse events were carefully monitored via telephone contact throughout the trial and were reported to the Institutional Review Board (IRB) of the University of California, San Diego, and the NIA program official following National Institutes of Health (NIH) guidelines.
Eye disorders Non serious adverse event	4.8% 1/21 • Number of events 1 • 12 weeks Adverse events recording followed the National Institute on Aging (NIA) Adverse Event and Serious Adverse Event Guidelines as outlined by the study's Data and Safety Monitoring Plan (DSMP), which included a safety officer. All adverse events were carefully monitored via telephone contact throughout the trial and were reported to the Institutional Review Board (IRB) of the University of California, San Diego, and the NIA program official following National Institutes of Health (NIH) guidelines.	0.00% 0/22 • 12 weeks Adverse events recording followed the National Institute on Aging (NIA) Adverse Event and Serious Adverse Event Guidelines as outlined by the study's Data and Safety Monitoring Plan (DSMP), which included a safety officer. All adverse events were carefully monitored via telephone contact throughout the trial and were reported to the Institutional Review Board (IRB) of the University of California, San Diego, and the NIA program official following National Institutes of Health (NIH) guidelines.
Musculoskeletal and connective tissue disorders Non serious adverse event	4.8% 1/21 • Number of events 1 • 12 weeks Adverse events recording followed the National Institute on Aging (NIA) Adverse Event and Serious Adverse Event Guidelines as outlined by the study's Data and Safety Monitoring Plan (DSMP), which included a safety officer. All adverse events were carefully monitored via telephone contact throughout the trial and were reported to the Institutional Review Board (IRB) of the University of California, San Diego, and the NIA program official following National Institutes of Health (NIH) guidelines.	0.00% 0/22 • 12 weeks Adverse events recording followed the National Institute on Aging (NIA) Adverse Event and Serious Adverse Event Guidelines as outlined by the study's Data and Safety Monitoring Plan (DSMP), which included a safety officer. All adverse events were carefully monitored via telephone contact throughout the trial and were reported to the Institutional Review Board (IRB) of the University of California, San Diego, and the NIA program official following National Institutes of Health (NIH) guidelines.
Social circumstances Non serious adverse event	0.00% 0/21 • 12 weeks Adverse events recording followed the National Institute on Aging (NIA) Adverse Event and Serious Adverse Event Guidelines as outlined by the study's Data and Safety Monitoring Plan (DSMP), which included a safety officer. All adverse events were carefully monitored via telephone contact throughout the trial and were reported to the Institutional Review Board (IRB) of the University of California, San Diego, and the NIA program official following National Institutes of Health (NIH) guidelines.	4.5% 1/22 • Number of events 1 • 12 weeks Adverse events recording followed the National Institute on Aging (NIA) Adverse Event and Serious Adverse Event Guidelines as outlined by the study's Data and Safety Monitoring Plan (DSMP), which included a safety officer. All adverse events were carefully monitored via telephone contact throughout the trial and were reported to the Institutional Review Board (IRB) of the University of California, San Diego, and the NIA program official following National Institutes of Health (NIH) guidelines.

Additional Information

Dr. Zvinka Zlatar

University of California, San Diego

Phone: 858-822-7737

Email: zzlatar@health.ucsd.edu

Results disclosure agreements

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