Comparing Tai Chi Training to a Low-Stress Physical Activity to Enhance Sleep in Older Adults

This study has been completed.

Sponsor:

Information provided by:

National Institute of Mental Health (NIMH)

ClinicalTrials.gov Identifier:

NCT00079664

First received: March 10, 2004

Last updated: November 18, 2005

Last verified: September 2005

History of Changes

Tracking Information
First Received Date ^ICMJE	March 10, 2004
Last Updated Date	November 18, 2005
Start Date ^ICMJE	March 2002
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00079664 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Comparing Tai Chi Training to a Low-Stress Physical Activity to Enhance Sleep in Older Adults
Official Title ^ICMJE	Tai Chi Training and Sleep Enhancement in the Elderly
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.
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Sleep Deprivation Sleep Initiation and Maintenance Disorders
Intervention ^ICMJE	Behavioral: Tai Chi
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	100
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	60 Years and older
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00079664
Other Study ID Numbers ^ICMJE	R03 MH62327, DSIR AT-SO
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	National Institute of Mental Health (NIMH)
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	National Institute of Mental Health (NIMH)
Verification Date	September 2005
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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