Independent Walking for Brain Health

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Novel Mobile Health Exercise Intervention in Aging: Brain Perfusion and Cognition

Conditions
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Physical Activity, Aging

Intervention / Treatment
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* Behavioral: Mobile Health Walking Condition
* Behavioral: Healthy Aging Education Condition


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Controlled Trial with ongoing enrollment into each arm (individual intervention)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mobile Health Walking Condition<br>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<br>* 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.<br>|
| Active Comparator: Healthy Aging Education Condition<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Pre (baseline) and post (3 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Pre (baseline) and post (3 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise, Fitness, Physical Activity, Cognitive Aging, Cerebral Blood Flow, Brain Imaging, Unsupervised Intervention, Mobile Health, Free-living exercise intervention