- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00079664
Comparing Tai Chi Training to a Low-Stress Physical Activity to Enhance Sleep in Older Adults
Tai Chi Training and Sleep Enhancement in the Elderly
Study Overview
Status
Intervention / Treatment
Detailed Description
Elderly individuals often suffer from sleep disturbances. Chronic sleep problems can cause significant medical, psychological, and social disruptions. Although many sleep-related studies exist, few studies have focused on improving quality of sleep. Tai Chi, an exercise that incorporates meditation and breathing with whole body movements, may improve the quality of sleep and health status of elderly individuals.
Participants will be randomly assigned to either a Tai Chi group or a conventional exercise control group. Participants in each group will exercise for 60 minutes, 3 times per week, for 6 months. Assessment of sleep quality and health status will be done at study start, 3 months, 6 months, at the end of the study, and at a 3-month follow-up visit.
Study Type
Enrollment
Phase
- Phase 1
Contacts and Locations
Study Locations
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Oregon
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Eugene, Oregon, United States, 97403
- Oregon Research Institute
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Sedentary, as defined by a lack of regular exercise during the previous 6 months
- Healthy to the degree that participation in exercise testing and an exercise program would not exacerbate any existing disease condition
- Physician's clearance for participation
- Willingness to adhere to the conditions of the study
Exclusion Criteria:
- Sleep medication or other psychotropic medication during the study
- Current sleep disorder treatment
- Significant cognitive impairment as indicated by a score of 3 on the Pfeiffer Mental Status Questionnaire
- More than 7 alcoholic beverages per week or use of alcohol close to bedtime
- Smoking more than 10 cigarettes per day
- Score of 5 or higher in the Pittsburgh Sleep Quality Index questionnaire
- Score of 3 or higher on 2 out of 3 sleep items drawn from the Sleep Questionnaire and Assessment of Wakefulness
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R03MH062327 (U.S. NIH Grant/Contract)
- DSIR AT-SO (NorthShore LIJ Health System)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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