The Effectiveness of Regular Exercise on Improving Sleep in Older Adults (RTC)
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|ClinicalTrials.gov Identifier: NCT00149747|
Recruitment Status : Completed
First Posted : September 8, 2005
Results First Posted : May 1, 2014
Last Update Posted : May 24, 2016
|Condition or disease||Intervention/treatment||Phase|
|Sleep Initiation and Maintenance Disorders Sleep Disorders, Intrinsic||Behavioral: Moderate-Intensity Aerobic Physical Activity Behavioral: Health Education Class||Phase 2 Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||66 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Promoting Exercise, Sleep and Well-Being in Older Adults|
|Study Start Date :||August 1999|
|Actual Primary Completion Date :||September 2003|
|Actual Study Completion Date :||September 2003|
Experimental: Exercise training
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
Moderate-Intensity Aerobic Physical Activity. 4+ days per week, 60+ minutes per day, moderate or greater intensity physical activity
Other Name: Comprehensive fitness class
Placebo Comparator: 2
Attention-control of exposure to study staff. Weekly general health education classes conducted in group sessions.
Behavioral: Health Education Class
2 classes a week, 90+minutes per class, general health education, excluding information on physical activity
Other Name: Healthy Aging Workshops
- % Time in Stage 2 Sleep at 12 Months, Adjusted for Baseline [ Time Frame: baseline, 12 months ]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).
- Sleep Disturbances [ Time Frame: 12 months ]
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.
- Peak Exercise Oxygen Consumption [ Time Frame: 12 months ]Peak oxygen consumption measured during symptom limited treadmill exercise stress test
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00149747
|United States, California|
|Stanford Prevention Research Center|
|Stanford, California, United States, 94305-5705|
|Principal Investigator:||Abby C King, PhD||Stanford University|