Sleep DeprivationPhase 1NCT00079664
Comparing Tai Chi Training to a Low-Stress Physical Activity to Enhance Sleep in Older Adults
A Phase 1 study testing Tai Chi in people with Sleep Deprivation and Sleep Initiation and Maintenance Disorders, run by Oregon Research Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep Deprivation, Sleep Initiation and Maintenance Disorders
- What is being tested?
- Tai Chi
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2001to Jul 2003
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tai Chi Training and Sleep Enhancement in the Elderly
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.
Read the 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.
- Being tested
- Tai Chi
- Keywords
- Tai Ji
- Medical subject headings
- Sleep Deprivation, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tai ChiBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2004 (estimated)
- Study startSep 2001
- Primary completionMar 2002
- Study completionJul 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DeprivationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- Oregon Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00079664
- Sponsor's protocol ID
- R03MH062327
- Other IDs
- R03MH062327, DSIR AT-SO
- Status last verified
- Sep 2013
- First submitted
- 10 Mar 2004
- Last updated
- 1 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tai Chi Training and Sleep Enhancement in the Elderly
- ClinicalTrials.gov ID
- NCT00079664
- Acronym / sponsor ID
- R03MH062327
- Keywords
- Tai Ji
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- Oregon Research InstituteUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Sep 2001
- Primary completion
- Mar 2002 (actual)
- Study completion
- Jul 2003 (actual)
- First posted
- 12 Mar 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tai Chi | Behavioural | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tai Chi in people with Sleep Deprivation and Sleep Initiation and Maintenance Disorders, run by Oregon Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2013.