The Effectiveness of Regular Exercise on Improving Sleep in Older Adults

Study Overview
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Brief Summary
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This study will evaluate the effect of regular aerobic exercise on improving sleep in older adults with moderate difficulty sleeping.

Detailed Description
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Sleep deprivation is a common problem among older adults. It is often at the root of increased mortality and some psychiatric disorders. Regular participation in a medium-intensity exercise regimen may help people sleep better. This study will assess the effectiveness of a regular exercise program on improving sleep in older adults with moderate difficulty sleeping. Participants will be randomly assigned to one of two conditions. One group will partake in a moderate-intensity physical activity training regimen. The other group will act as a non-exercise attention-control comparison group. Each group will undergo its assigned treatment for 12 months. Sleep quantity and quality will be measured objectively using in-home polysomnography. Subjective sleep quality and health-related quality of life measures will be evaluated with questionnaires. All measurements will be performed at the beginning of the study, Month 6, and Month 12.

Official Title
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Promoting Exercise, Sleep and Well-Being in Older Adults

Conditions
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Sleep Initiation and Maintenance Disorders, Sleep Disorders, Intrinsic

Intervention / Treatment
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* Behavioral: Moderate-Intensity Aerobic Physical Activity
* Behavioral: Health Education Class


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Moderate difficulty sleeping unrelated to a physical illness or psychopathology (determined by the Sleep Questionnaire and Assessment of Wakefulness) Currently not physically active on a regular basis Body mass index less than 38 Exclusion Criteria: Currently physically active on a regular basis Diagnosed with a clinically significant sleep disorder Mild or no sleep complaints (determined by the Sleep Questionnaire and Assessment of Wakefulness) Unstable on medications Current smoker Consumes more than three alcoholic beverages per day Medical condition that may limit participation in moderate-intensity exercise Diagnosed with clinical psychopathology

Ages Eligible for Study
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Minimum Age: 55 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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise training<br>Group based exercise training. Two weekly classes including aerobic endurance physical activity and strength and flexibility training, and up to three home-based sessions of similar composition of aerobic endurance, strength and flexibility training. | Behavioral: Moderate-Intensity Aerobic Physical Activity<br>* Moderate-Intensity Aerobic Physical Activity. 4+ days per week, 60+ minutes per day, moderate or greater intensity physical activity<br>* Other names: Comprehensive fitness class;|
| Placebo Comparator: 2<br>Attention-control of exposure to study staff. Weekly general health education classes conducted in group sessions. | Behavioral: Health Education Class<br>* 2 classes a week, 90+minutes per class, general health education, excluding information on physical activity<br>* Other names: Healthy Aging Workshops;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % Time in Stage 2 Sleep at 12 Months, Adjusted for Baseline | Percent of total sleep time spent in Stage 2 sleep at 12 months after adjusting for baseline level of Stage 2 sleep (i.e., baseline value included as a covariate in regression models conducted). | baseline, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep Disturbances | Self-reported sleep disturbance subscale on Pittsburgh Sleep Quality Index Subscale consists of 9 items scored on a range of 0 to 3, 0 indicating no disturbance and 3 indicating frequent disturbance. All 9 items are summed, and the summary scores is captured by 1 of 4 categories ranging from 0 to 3, with 0 indicating less frequent disturbances and 3 indicating greater frequency of disturbances. | 12 months | 
| Peak Exercise Oxygen Consumption | Peak oxygen consumption measured during symptom limited treadmill exercise stress test | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sleep, Exercise, Older Adults