Physical Activity and Cognition Study

Study Overview
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Brief Summary
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The goal of this research study is to examine whether an intervention to increase physical activity using a body-worn sensor affects cognitive (thinking) processes.

Detailed Description
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The overall duration of participation in this research study is approximately 4 months. During this time, three study visits will be required. The first visit is for informed consent and screening, the second visit is for baseline fitness and cognitive testing, and the third visit is for follow-up fitness and cognitive testing after a 12-week physical activity monitoring program. Participants will be randomized to one of two study arms, a physical activity monitoring arm and a flexibility and balance arm. Both study arms involve wearing a physical activity sensor and monitoring physical activity for a duration of 12 weeks.

Official Title
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Feasibility of Using Physical Activity Monitoring for Enhancing Cognition in Healthy Seniors

Conditions
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Aging

Intervention / Treatment
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* Behavioral: Physical Activity


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Non-smoking Age between 55-85 years Sedentary status (physically inactive; not participating in at least 30 minutes of moderate intensity physical activity on at least three days per week for at least three months) Generally healthy men and women Living in the greater Boston area Available for the 4 month duration of the study Native-English speaking or fluent in English (must have attended elementary school and higher in English) Exclusion Criteria: Poor vision that cannot be corrected with glasses or contact lenses Presence of an acute infection Diagnosis of kidney failure Diagnosis of liver disease Diagnosis of thyrotoxicosis/hyperthyroidism Diagnosis of cancer Past or present conditions that affect cognitive functioning: learning disability neurological disorders or conditions (movement disorder, history of head trauma or stroke, epilepsy, etc.) psychiatric disorders or conditions (depression, anxiety disorder, etc.) Past or present conditions that are counter indicators for participation in cardio-respiratory fitness assessment and moderate-intensity physical activity: heart conditions (e.g. heart attack, arrhythmias, etc.) circulatory conditions (e.g. uncontrolled hypertension, leg claudication, high cholesterol, etc.) respiratory conditions (e.g., asthma or lung conditions, such as chronic obstructive pulmonary disease, acute bronchitis, acute common cold, lung cancer, pneumonia, etc.) current musculoskeletal impairments (e.g. fractures, hemiplegia, chronic joint pain, arthritis, osteoporosis, not able to walk comfortably without assistance, etc.) diagnosis of electrolyte disorder or abnormality presence of diabetes mellitus Obesity Prescription medication or other drugs that treat heart, lung, or circulatory conditions (e.g. beta blockers, bronchodilators, etc.) Prescription medication or other drugs that affect chemicals in the brain (e.g. antidepressants, anxiolytics, etc.) Implanted medical devices, such as a pacemaker or defibrillator Unavailable for the approx. 4-month duration of the study

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 85 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physical activity monitoring<br>Participants will wear a physical activity sensor on the hip or waist with a belt. They will be instructed to increase their physical activity level to at least 150 min of moderate-intensity physical activity per week. They will be asked to follow guidelines in the Go4Life brochure, website, and/or videos by the National Institute on Aging. Participants will receive weekly phone calls to monitor their progress, to provide feedback, and to suggest example exercises. | Behavioral: Physical Activity<br>* Trainer-guided at-home behavioral intervention<br>|
| Active Comparator: Flexibility and balance<br>Participants will wear a physical activity sensor on the hip or waist with a belt. They will be instructed to increase their balance and flexibility over the 12 week period of the intervention. They will be asked to follow guidelines in the Go4Life brochure, website, and/or videos by the National Institute on Aging. Participants will receive weekly phone calls to monitor their progress, to provide feedback, and to suggest example exercises. | Behavioral: Physical Activity<br>* Trainer-guided at-home behavioral intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognition | Change in cognitive task performance post-intervention compared to baseline | 80-90 minutes | 
| Aerobic Fitness | Change aerobic fitness measured with treadmill test post-intervention | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional fitness: Five Times Sit to Stand | Change in performance in the Five Times Sit to Stand test post-intervention | 10 min | 
| Functional fitness: Timed Get Up and Go | Change in performance in the Timed Get Up and Go test post-intervention compared to baseline | 10 min | 
| Functional fitness: Flexibility | Change in performance in the Sit and Reach test post-intervention | 10 min | 
| Physical activity | Greater overall moderate-intensity physical activity time and step count and lower sedentary time in the physical activity monitoring than the flexibility and balance group | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognition, Learning, Memory, Executive Function, Attention, Neuropsychological Tests, Physical Activity, Physical Fitness, Exercise, Resistance Training, Walking, Muscle Stretching Exercises, Exercise Test, Balance, Flexibility, Body Composition