Aging, Physical Activity
Conditions
Keywords
Exercise, Fitness, Physical Activity, Cognitive Aging, Cerebral Blood Flow, Brain Imaging, Unsupervised Intervention, Mobile Health, Free-living exercise intervention
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALMobile Health Walking 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.
BEHAVIORALHealthy Aging Education 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.
Sponsors
National Institutes of Health (NIH)
National Institute on Aging (NIA)
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized Controlled Trial with ongoing enrollment into each arm (individual intervention)
Eligibility
Sex/Gender
ALL
Age
65 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Men and women between the ages of 65-80 * Ability to obtain a signed physician's clearance for participation in this study * English-speaking as needed to complete cognitive testing and follow study procedures * Cognitively normal (based on comprehensive neuropsychological assessment) * No contraindications for Magnetic Resonance Imaging (MRI) * Must be ambulatory and able to walk independently
Exclusion criteria
* History of head injury involving loss of consciousness within the past 6 months and/or history of severe traumatic brain injury * Major neurological disorders (dementia, multiple sclerosis, epilepsy, etc) * Chronic major psychiatric disorders (schizophrenia, major recurrent affective disorder) * History of major vascular events (myocardial infarction, stroke, etc), * History of diabetes * History of falls in the last year resulting in hospitalization * Unstable or poorly controlled medical problems e.g. heart failure, diabetes (poorly controlled or on insulin), uncontrolled hypertension, pulmonary disease with hypoxia or hypercapnia, significant liver problems or renal failure, treatment of cancer in the past 2 years (other than non-melanoma skin cancer), HIV positive * Objective evidence of cognitive impairment based on neuropsychological assessment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Moderate to Vigorous Physical Activity (MVPA) Average Per Day | Pre (baseline) and post (3 months) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cerebral Blood Flow (Hippocampal and Frontal) | Pre (baseline) and post (3 months) | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Memory Function | Pre (baseline) and post (3 months) | 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. |
| Executive Function | Pre (baseline) and post (3 months) | 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. |
| Cardiorespiratory Fitness | Pre (baseline) and post (3 months) | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| 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. | 21 |
| 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. | 22 |
| Total | 43 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Coronavirus (COVID)-19 shutdown | 0 | 1 |
| Overall Study | Withdrawal by Subject | 4 | 1 |
Baseline characteristics
| Characteristic | Physical Activity Condition | Healthy Aging Education Condition | Total |
|---|---|---|---|
| Age, Continuous | 71.24 years STANDARD_DEVIATION 4.27 | 72.27 years STANDARD_DEVIATION 4.14 | 71.77 years STANDARD_DEVIATION 4.19 |
| Baseline MVPA | 26.37 Average MVPA minutes per day STANDARD_DEVIATION 17.31 | 21.32 Average MVPA minutes per day STANDARD_DEVIATION 17.42 | 23.8 Average MVPA minutes per day STANDARD_DEVIATION 17.36 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 1 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 16 Participants | 21 Participants | 37 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 18 Participants | 22 Participants | 40 Participants |
| Region of Enrollment United States | 21 participants | 22 participants | 43 participants |
| Sex: Female, Male Female | 16 Participants | 16 Participants | 32 Participants |
| Sex: Female, Male Male | 5 Participants | 6 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 22 |
| other Total, other adverse events | 3 / 21 | 2 / 22 |
| serious Total, serious adverse events | 0 / 21 | 0 / 22 |
Outcome results
Primary
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)
Population: All participants who were randomized and completed the baseline sessions were included in the analyses (N=43).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Physical Activity Condition | 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 |
| Physical Activity Condition | 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 |
| Healthy Aging Education Condition | Moderate to Vigorous Physical Activity (MVPA) Average Per Day | Pre MVPA average minutes per day | 21.34 average minutes per day | Standard Deviation 17.44 |
| Healthy Aging Education Condition | Moderate to Vigorous Physical Activity (MVPA) Average Per Day | Post MVPA average minutes per day | 25.28 average minutes per day | Standard Deviation 15.99 |
Secondary
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)
Population: We provide descriptive statistics for pre and post cerebral blood flow in the hippocampus and frontal cortex.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Physical Activity Condition | Cerebral Blood Flow (Hippocampal and Frontal) | Pre hippocampal cerebral blood flow | 40.4 ml/100g/minute | Standard Deviation 10.82 |
| Physical Activity Condition | Cerebral Blood Flow (Hippocampal and Frontal) | Post hippocampal cerebral blood flow | 35.36 ml/100g/minute | Standard Deviation 5.56 |
| Physical Activity Condition | Cerebral Blood Flow (Hippocampal and Frontal) | Pre frontal cerebral blood flow | 45.52 ml/100g/minute | Standard Deviation 11.58 |
| Physical Activity Condition | Cerebral Blood Flow (Hippocampal and Frontal) | Post frontal cerebral blood flow | 41.31 ml/100g/minute | Standard Deviation 7.41 |
| Healthy Aging Education Condition | Cerebral Blood Flow (Hippocampal and Frontal) | Post frontal cerebral blood flow | 46.96 ml/100g/minute | Standard Deviation 10.7 |
| Healthy Aging Education Condition | Cerebral Blood Flow (Hippocampal and Frontal) | Pre hippocampal cerebral blood flow | 41.03 ml/100g/minute | Standard Deviation 12.24 |
| Healthy Aging Education Condition | Cerebral Blood Flow (Hippocampal and Frontal) | Pre frontal cerebral blood flow | 47.24 ml/100g/minute | Standard Deviation 10.46 |
| Healthy Aging Education Condition | Cerebral Blood Flow (Hippocampal and Frontal) | Post hippocampal cerebral blood flow | 40.99 ml/100g/minute | Standard Deviation 9.1 |
Other Pre-specified
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)
Population: Descriptive data are presented for pre and post.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Physical Activity Condition | Cardiorespiratory Fitness | Pre cardiorespiratory fitness (seconds) | 873.48 seconds | Standard Deviation 175.47 |
| Physical Activity Condition | Cardiorespiratory Fitness | Post cardiorespiratory fitness (seconds) | 995.71 seconds | Standard Deviation 157.43 |
| Healthy Aging Education Condition | Cardiorespiratory Fitness | Pre cardiorespiratory fitness (seconds) | 840.55 seconds | Standard Deviation 277.62 |
| Healthy Aging Education Condition | Cardiorespiratory Fitness | Post cardiorespiratory fitness (seconds) | 948.61 seconds | Standard Deviation 172.52 |
Other Pre-specified
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)
Population: All participants were included and descriptive statistics are presented for pre and post.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Physical Activity Condition | Executive Function | Pre executive function score | .15 z-score | Standard Deviation 0.69 |
| Physical Activity Condition | Executive Function | Post executive function score | .07 z-score | Standard Deviation 0.73 |
| Healthy Aging Education Condition | Executive Function | Pre executive function score | -.14 z-score | Standard Deviation 0.8 |
| Healthy Aging Education Condition | Executive Function | Post executive function score | -.06 z-score | Standard Deviation 0.84 |
Other Pre-specified
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)
Population: All participants completed neuropsychological testing at pre and post.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Physical Activity Condition | Memory Function | Pre memory score | .08 z-score | Standard Deviation 0.8 |
| Physical Activity Condition | Memory Function | Post memory score | -.10 z-score | Standard Deviation 0.94 |
| Healthy Aging Education Condition | Memory Function | Pre memory score | -.07 z-score | Standard Deviation 0.82 |
| Healthy Aging Education Condition | Memory Function | Post memory score | .09 z-score | Standard Deviation 0.68 |