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

Condition	Intervention	Phase
Sleep Initiation and Maintenance Disorders Sleep Disorders, Intrinsic	Behavior: Moderate-intensity aerobic physical activity  Behavior: Health Education class	Phase II Phase III

Further Study Details: 

Primary Outcomes: Total wake time at night,wake time after sleep onset, sleep latency, and percent of total sleep in stages 1, 2, 3, 4 and REM as measured by in-home polysomnography collected at baseline, 6 months, and 12 months
Secondary Outcomes: Subjective sleep quality, sleep duration, and sleep-onset latency as measured by the Pittsburgh Sleep Quality Index;; Physical performance as measured by symptom-limited treadmill exercise testing; all measures collected at baseline, 6 months, and 12 months
Expected Total Enrollment:  66

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.

Ages Eligible for Study:  55 Years and above,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

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

California
      Stanford Prevention Research Center, Stanford,  California,  94305-5705,  United States

Study chairs or principal investigators

Abby C King, Ph.D.,  Principal Investigator,  Stanford University   

Study ID Numbers:  R01-MH058853; R01 MH058853
Last Updated:  September 7, 2005
Record first received:  September 6, 2005
ClinicalTrials.gov Identifier:  NCT00149747
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-09-13