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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00079664
Other study ID # R03MH062327
Secondary ID R03MH062327DSIR
Status Completed
Phase Phase 1
First received March 10, 2004
Last updated September 30, 2013
Start date September 2001
Est. completion date July 2003

Study information

Verified date September 2013
Source Oregon Research Institute
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date July 2003
Est. primary completion date March 2002
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 60 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Tai Chi


Locations

Country Name City State
United States Oregon Research Institute Eugene Oregon

Sponsors (2)

Lead Sponsor Collaborator
Oregon Research Institute National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

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