The Effectiveness of Regular Exercise on Improving Sleep in Older Adults (RTC)

Stanford University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Sleep Initiation and Maintenance Disorders; Sleep Disorders, Intrinsic

Treatments: Behavioral: Health Education Class; Behavioral: Moderate-Intensity Aerobic Physical Activity

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00149747

DAHBR HB-C

R01MH058853 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full description

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.

Enrollment: 66 patients

Sex: All

Ages: 55+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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66 participants in 2 patient groups, including a placebo group

Exercise training

Experimental group

Description:

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.

Treatment:

Behavioral: Moderate-Intensity Aerobic Physical Activity

2

Placebo Comparator group

Description:

Attention-control of exposure to study staff. Weekly general health education classes conducted in group sessions.

Treatment:

Behavioral: Health Education Class