Back to resultsComparing Tai Chi Training to a Low-Stress Physical Activity to Enhance Sleep in Older Adults
Primary Purpose
Sleep Deprivation, Sleep Initiation and Maintenance Disorders
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Tai Chi
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Deprivation focused on measuring Tai Ji
Eligibility Criteria
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
Sites / Locations
- Oregon Research Institute
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00079664
First Posted
March 10, 2004
Last Updated
September 30, 2013
Sponsor
Oregon Research Institute
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00079664
Brief Title
Comparing Tai Chi Training to a Low-Stress Physical Activity to Enhance Sleep in Older Adults
Official Title
Tai Chi Training and Sleep Enhancement in the Elderly
Study Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
September 2001 (undefined)
Primary Completion Date
March 2002 (Actual)
Study Completion Date
July 2003 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oregon Research Institute
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to examine the effects of Tai Chi, in comparison to conventional exercise, on the quality of sleep among sedentary older adults.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Deprivation, Sleep Initiation and Maintenance Disorders
Keywords
Tai Ji
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Tai Chi
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Oregon Research Institute
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97403
Country
United States
12. IPD Sharing Statement
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Comparing Tai Chi Training to a Low-Stress Physical Activity to Enhance Sleep in Older Adults
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