An interventional study of Mobile Health Walking Condition and Healthy Aging Education Condition in Physical Activity and Aging, sponsored by University of California, San Diego. Terminated at 1 site in United States. Open to participants aged 65 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-17.
Sponsored by University of California, San Diego · Not applicable, Interventional, and Treatment
Physical activity interventions with older adults can improve brain health; however most interventions have been performed in gym-like settings that reach a small sector of the senior population. Since not everyone can access a gym, it is important to study whether brisk walking in real world environments can also help brain health. This study will use mobile health devices to help older adults independently walk for brain health, thus representing a critical step towards the dissemination of physical activity intervention programs aimed at preserving cognitive function in aging.
Physical activity interventions conducted in supervised settings (laboratories and group settings) with older adults have consistently shown improved cardiovascular and cerebrovascular health and improved cognitive function. What is lacking is the development of interventions that take place in real world environments and that take advantage of new technologies to help objectively track real time physical activity behaviors. Real world physical activity interventions have the potential to reach a larger segment of the population and to enhance maintenance after the intervention period ends. This study will develop a novel physical activity intervention using mobile health technologies to promote physical activity levels likely to affect cerebral blood flow and cognition in real world environments in cognitively normal older adults. A randomized controlled trial will be conducted with 30 participants being assigned to the mobile health physical activity condition (walking in free-living environments tracked via mobile health technologies) and another 30 to an education control condition (at home reading about healthy aging materials) for 3 months.
University of California, San Diego is the lead sponsor of 958 studies on the registry; 191 are open to participants now.
Of its 110 completed or terminated interventional studies of FDA-regulated products, 70 (64%) have results posted.
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Exclusion Criteria:
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.
Behavioral: Mobile Health Walking Condition
The education control condition will provide participants with printed materials and homework assignments on issues related to successful aging, such as nutrition, social activity, cognitive and social engagement.
Behavioral: Healthy Aging Education 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.
The education control condition will provide participants with printed materials and homework assignments on issues related to successful aging, such as nutrition, social activity, cognitive and social engagement.
Moderate to Vigorous Physical Activity (MVPA) Average Per Day
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.
Time frame: Pre (baseline) and post (3 months)
Cerebral Blood Flow (Hippocampal and Frontal)
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.
Time frame: Pre (baseline) and post (3 months)
Memory Function
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.
Time frame: Pre (baseline) and post (3 months)
Executive Function
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.
Time frame: Pre (baseline) and post (3 months)
Cardiorespiratory Fitness
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.
Time frame: Pre (baseline) and post (3 months)
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.
| Milestone | Physical Activity Condition | Healthy Aging Education Condition |
|---|---|---|
| Started | 21 | 23 |
| Completed | 17 | 21 |
| Not completed | 4 | 2 |
| Withdrew: Withdrawal by subject | 4 | 1 |
| Withdrew: Coronavirus (covid)-19 shutdown | 0 | 1 |
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.
| average minutes per day | Physical Activity Condition | Healthy Aging Education Condition |
|---|---|---|
| Pre MVPA average minutes per day | 26.37 ± 17.31 | 21.34 ± 17.44 |
| Post MVPA average minutes per day | 44.09 ± 25.28 | 25.28 ± 15.99 |
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.
| ml/100g/minute | Mobile Health Walking Condition | Healthy Aging Education Condition |
|---|---|---|
| Pre hippocampal cerebral blood flow | 40.4 ± 10.82 | 41.03 ± 12.24 |
| Post hippocampal cerebral blood flow | 35.36 ± 5.56 | 40.99 ± 9.1 |
| Pre frontal cerebral blood flow | 45.52 ± 11.58 | 47.24 ± 10.46 |
| Post frontal cerebral blood flow | 41.31 ± 7.41 | 46.96 ± 10.7 |
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.
| z-score | Physical Activity Condition | Healthy Aging Education Condition |
|---|---|---|
| Pre memory score | .08 ± .8 | -.07 ± .82 |
| Post memory score | -.10 ± .94 | .09 ± .68 |
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.
| z-score | Physical Activity Condition | Healthy Aging Education Condition |
|---|---|---|
| Pre executive function score | .15 ± .69 | -.14 ± .80 |
| Post executive function score | .07 ± .73 | -.06 ± .84 |
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.
| seconds | Physical Activity Condition | Healthy Aging Education Condition |
|---|---|---|
| Pre cardiorespiratory fitness (seconds) | 873.48 ± 175.47 | 840.55 ± 277.62 |
| Post cardiorespiratory fitness (seconds) | 995.71 ± 157.43 | 948.61 ± 172.52 |
Collected over 12 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Physical Activity Condition | 0/21 (0%) | 0/21 (0%) | 3/21 (14.3%) |
| Healthy Aging Education Condition | 0/22 (0%) | 0/22 (0%) | 2/22 (9.1%) |
| Event | Physical Activity Condition | Healthy Aging Education Condition |
|---|---|---|
| Non serious adverse eventRenal and urinary disorders | 1/21 | 0/22 |
| Non serious adverse eventEye disorders | 1/21 | 0/22 |
| Non serious adverse eventMusculoskeletal and connective tissue disorders | 1/21 | 0/22 |
| Non serious adverse eventSocial circumstances | 0/21 | 1/22 |
| Non serious adverse eventSocial circumstances | 0/21 | 1/22 |
In total, 44 participants were randomized to the intervention, with 21 in the Physical Activity Condition and 23 in the Healthy Aging Education Condition. One participant who was randomized to the Healthy Aging Education Condition could not finalize the baseline measurement appointment due to the COVID-19 pandemic shutting down research operations. Therefore, the analytical sample consisted of 43 participants.
| Age, Continuous(years) | Physical Activity Condition | Healthy Aging Education Condition | Total |
|---|---|---|---|
| Mean | 71.24 ± 4.27 | 72.27 ± 4.14 | 71.77 ± 4.19 |
| Sex: Female, Male(Participants) | Physical Activity Condition | Healthy Aging Education Condition | Total |
|---|---|---|---|
| Female | 16 | 16 | 32 |
| Male | 5 | 6 | 11 |
| Ethnicity (NIH/OMB)(Participants) | Physical Activity Condition | Healthy Aging Education Condition | Total |
|---|---|---|---|
| Hispanic or Latino | 2 | 1 | 3 |
| Not Hispanic or Latino | 16 | 21 | 37 |
| Unknown or Not Reported | 3 | 0 | 3 |
| Race (NIH/OMB)(Participants) | Physical Activity Condition | Healthy Aging Education Condition | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 2 | 0 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 18 | 22 | 40 |
| More than one race | 1 | 0 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Physical Activity Condition | Healthy Aging Education Condition | Total |
|---|---|---|---|
| United States | 21 | 22 | 43 |
| Baseline MVPA(Average MVPA minutes per day) | Physical Activity Condition | Healthy Aging Education Condition | Total |
|---|---|---|---|
| Mean | 26.37 ± 17.31 | 21.32 ± 17.42 | 23.8 ± 17.36 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — Access to databases and associated software tools generated under the project will be available for educational, research and non-profit purposes. Such access will be provided using web-based applications, as appropriate. Publication of data shall occur during and at the end of the project, consistent with normal scientific practices. Research data which documents, supports and validates research findings will be made available after the main findings from the final research data set have been accepted for publication. Such research data will be redacted to prevent the disclosure of personal identifiers.
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University of California, San Diego