COPDPhase 1NCT01027338
Tai Chi Exercise in Patients With COPD
A Phase 1 study testing Tai chi exercise in people with COPD, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
Trial summary
This is a pilot randomized controlled trial of feasibililty and prelimnary effects of a 12 week tai chi intervention vs. usual care in patients with chronic obstructive pulmonary disease Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- COPD
- What is being tested?
- Tai chi exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- physician diagnosis of COPD
- FEV1<65% of predicted and FEV1/FVC<70% of predicted
- ≥45 years old
Who cannot join
- COPD exacerbation requiring ER visit or hospitalization within past month
- planned major pulmonary intervention in coming 3 months
- severe peripheral vascular disease/claudication or other physical condition precluding walk test
- inability to perform bicycle ergometry
- severe cognitive dysfunction (MMSE ≤ 24)
- inability to speak English
- current participation in a pulmonary rehabilitation or regular practice of tai chi
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: Tai Chi Exercise in Patients With Chronic Obstructive Pulmonary Disease
This is a pilot randomized controlled trial of feasibililty and prelimnary effects of a 12 week tai chi intervention vs. usual care in patients with chronic obstructive pulmonary disease
- Conditions
- COPD
- Being tested
- Tai chi exercise
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tai chi exerciseOther
| Study group | Role | What they receive |
|---|---|---|
| Tai Chi Exercise | Experimental | Not described Receives: Other: Tai chi exercise |
| Usual Care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
study feasibility
Secondary outcomes (2)
quality of life
exercise capacity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies 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
Sponsor and investigators
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)
- Sponsor type
- US National Institutes of Health
- Investigators
- Gloria Y Yeh, MD, MPH, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01027338
- Sponsor's protocol ID
- K24AT000589
- Status last verified
- Dec 2009
- First submitted
- 4 Dec 2009
- Last updated
- 7 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tai Chi Exercise in Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT01027338
- Acronym / sponsor ID
- K24AT000589
- Conditions
- COPD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)US National Institutes of Health
- First posted
- 7 Dec 2009 (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.
This is a pilot randomized controlled trial of feasibililty and prelimnary effects of a 12 week tai chi intervention vs. usual care in patients with chronic obstructive pulmonary disease
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tai Chi Exercise | Experimental | Other: Tai chi exercise |
| Usual Care | No intervention | – |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- physician diagnosis of COPD
- FEV1<65% of predicted and FEV1/FVC<70% of predicted
- ≥45 years old
Key exclusion criteria (7 listed)
- COPD exacerbation requiring ER visit or hospitalization within past month
- planned major pulmonary intervention in coming 3 months
- severe peripheral vascular disease/claudication or other physical condition precluding walk test
- inability to perform bicycle ergometry
- severe cognitive dysfunction (MMSE ≤ 24)
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 exercise | Other | Tai Chi Exercise |
Primary outcome
study feasibility
2 secondary outcomes
quality of life
exercise capacity
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 7 Dec 2009.
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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.
Gloria Y Yeh, MD, MPH principal investigator
Beth Israel Deaconess Medical Center
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 exercise in people with COPD, run by National Center for Complementary and Integrative Health (NCCIH) 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 3 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 7 Dec 2009. 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.
What does the primary outcome measure?
study feasibility. It is what the study was designed to measure, not a finding.
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 7 Dec 2009.