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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00149747 |
This study will evaluate the effect of regular aerobic exercise on improving sleep in older adults with moderate difficulty sleeping.
Condition | Intervention | Phase |
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Sleep Initiation and Maintenance Disorders Sleep Disorders, Intrinsic |
Behavioral: Moderate-Intensity Aerobic Physical Activity Behavioral: Health Education Class |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Promoting Exercise, Sleep and Well-Being in Older Adults |
Enrollment: | 66 |
Study Start Date: | August 1999 |
Study Completion Date: | September 2003 |
Primary Completion Date: | September 2003 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Regular, aerobic endurance physical activity
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Behavioral: Moderate-Intensity Aerobic Physical Activity
4+ days per week, 60+ minutes per day, moderate or greater intensity physical activity
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2: Placebo Comparator
Weekly general health education classes
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Behavioral: Health Education Class
2 classes a week, 90+minutes per class, general health education, excluding information on physical activity
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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.
Ages Eligible for Study: | 55 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Stanford University ( Abby C. King, Principal Investigator ) |
Study ID Numbers: | R01 MH58853, DAHBR HB-C |
Study First Received: | September 6, 2005 |
Last Updated: | January 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00149747 |
Health Authority: | United States: Federal Government |
Sleep Exercise Older Adults |
Sleep Initiation and Maintenance Disorders Signs and Symptoms Mental Disorders Neurologic Manifestations |
Dyssomnias Sleep Disorders Sleep Disorders, Intrinsic |
Pathologic Processes Disease Nervous System Diseases |