Completed

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

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What is being tested

Tai Chi

Behavioral
Who is being recruted

Sleep Deprivation

+ Sleep Initiation and Maintenance Disorders
Over 60 Years
+11 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: September 2001

See protocol details

Summary

Principal SponsorOregon Research Institute
Last updated: October 1, 2013
Sourced from a government-validated database.Claim as a partner
Study start date: September 1, 2001Actual date on which the first participant was enrolled.

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. 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.

Official TitleTai Chi Training and Sleep Enhancement in the Elderly 
Principal SponsorOregon Research Institute
Last updated: October 1, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
100 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 60 YearsRange of ages for which participants are eligible to join.
Healthy volunteers allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Sleep Deprivation
Sleep Initiation and Maintenance Disorders
Criteria
4 inclusion criteria required to participate
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
7 exclusion criteria prevent from participating
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

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Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
Oregon Research InstituteEugene, United StatesSee the location
CompletedOne Study Center