Chronic Obstructive Pulmonary Disease (COPD)NCT02370654
Chen-style Tai Chi in Pulmonary Rehabilitation for Chronic Obstructive Pulmonary Disease
A study testing Tai chi and Conventional exercise in people with Chronic Obstructive Pulmonary Disease (COPD), run by Laval University at 1 site in Canada.
Trial summary
This study will evaluate the effects of Chen-style Tai Chi compared to conventional exercise in pulmonary rehabilitation for COPD patients. Half of participants will receive the Chen-style Tai Chi intervention, while the other half will receive the conventional exercise intervention. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Tai chi and Conventional exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2014to 1 Jul 2017
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- FEV1 between 30 and 80% of the predicted normal values
- FEV1/FVC ratio < 70%
Who cannot join
- Patients with very severe COPD (GOLD IV);
- Patients that had a COPD exacerbations within the preceding 2 weeks of the baseline assessments;
- Significant hypoxemia at rest or during exercise (SpO2 <85%);
- Already following a rehabilitation program;
- Have physical limitations that compromises participation to a Tai chi and a conventional exercise program
Trial locations and contacts
1 site in 1 country.
Canada1 site
Institut universitaire de cardiologie et de pneumologie de Québec
Québec, G1V 4G5
About this study
This study will evaluate the effects of Chen-style Tai Chi compared to conventional exercise in pulmonary rehabilitation for COPD patients. Half of participants will receive the Chen-style Tai Chi intervention, while the other half will receive the conventional exercise intervention. Both groups will receive the same eduction and support during pulmonary rehabilitation.
- Being tested
- Tai chi, Conventional exercise
- Keywords
- COPD, Tai chi, Pulmonary rehabilitation
- 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 chiBehavioural
Conventional exerciseBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Tai Chi | Experimental | 12 week Tai chi intervention, 3 sessions per week, 90 minutes per session Receives: Behavioral: Tai chi |
| Conventional exercise | Active comparator | 12 week conventional exercise intervention, 3 sessions per week, 90 minutes per session Receives: Behavioral: Conventional exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline dyspnea at 12 weeks
Dyspnea will be assessed using the chronic respiratory questionnaire (CRQ)
Measured: Baseline, 12 weeks
Secondary outcomes (10)
Change from baseline lung function at week 12 (Spirometry and whole-body plethysmography)
Spirometry and whole-body plethysmography will be used for baseline and post-training (12 weeks) lung function testing.
Measured: Baseline, 12 weeks
Change from baseline walking distance at 12 weeks (distance walked during the six-minute walk test)
The distance walked during the six-minute walk test will be used to evaluate the functional exercise capacity of all participants at baseline and post-rehabilitation.
Measured: Baseline, 12 weeks
Change from baseline exercise capacity at 12 weeks(Endurance time during a constant work rate bicycle ergometry exercise test)
Endurance time during a constant work rate bicycle ergometry exercise test will be used to evaluate the exercise capacity of all participants at baseline and post-rehabilitation.
Measured: Baseline, 12 weeks
Change from baseline isokinetic quadriceps muscle function at 12 weeks
Voluntary isokinetic quadriceps muscle function will be determined by quantification of force, endurance, and fatigability of the dominant quadriceps during a series of 30 repetitions at an angular velocity of 90°/s of a knee extension test.
Measured: Baseline, 12 weeks
Change from baseline isometric quadriceps muscle strength at 12 weeks (force of the dominant quadriceps will be measured during a single magnetic stimulation of the femoral nerve)
The force of the dominant quadriceps will be measured during a single magnetic stimulation of the femoral nerve (Twitch force of the quadriceps [Twq]) and during a maximum voluntary contraction (MVC).
Measured: Baseline, 12 weeks
Change from baseline physical activity at 12 weeks (participants will be equipped with a physical activity monitor)
To monitor physical activity, participants will be equipped with a physical activity monitor. The device will monitor the daily energy expenditure, the duration of physical activities above the pre-determined intensity level (Metabolic Equivalent of Task (MET) >3), and also the total daily number of steps.
Measured: Baseline, 12 weeks
Change from baseline quality of life (QoL) at 12 weeks
In addition to dyspnea (primary outcome), the CRQ will be used also to measure other physical-functional limitations due to COPD with questions related to fatigue and energy levels.
Measured: Baseline, 12 weeks
Change from baseline health status at 12 weeks (determined with the COPD Assessment test (CAT).
Impact of COPD on a person's life will be determined with the COPD Assessment test (CAT).
Measured: Baseline, 12 weeks
Change from baseline balance (Berg Balance Test (BBT) at 12 weeks
The Berg Balance Test (BBT) will be used to evaluate the effect of the interventions on patient's balance.
Measured: Baseline, 12 weeks
Change from baseline of composite serum and plasma biomarkers at 12 weeks
During the baseline assessment and after the rehabilitation program, blood samples from patients will be taken in order to investigate the effect of the interventions on different biomarkers related to systemic inflammation.
Measured: Baseline, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2015 (estimated)
- Study startMar 2014
- Primary completion1 Jul 2017
- Study completion1 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- Saey, Didier, M.D., Maltais, Francois, M.D.
- Responsible party
- Principal investigator, Louis Gendron, Laval University
- Investigators
- François Maltais, MD, PhD, Principal investigator, Francois.Maltais@fmed.ulaval.ca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02370654
- Sponsor's protocol ID
- TCCOPD CER21009
- Status last verified
- Apr 2018
- First submitted
- 11 Feb 2015
- Last updated
- 24 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chen-style Tai Chi in Pulmonary Rehabilitation for Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT02370654
- Acronym / sponsor ID
- TCCOPD CER21009
- Keywords
- COPD, Tai chi, Pulmonary rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- Saey, Didier, M.D., Maltais, Francois, M.D.
- Study start
- Mar 2014
- Primary completion
- 1 Jul 2017 (actual)
- Study completion
- 1 Jul 2017 (actual)
- First posted
- 25 Feb 2015 (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 study will evaluate the effects of Chen-style Tai Chi compared to conventional exercise in pulmonary rehabilitation for COPD patients. Half of participants will receive the Chen-style Tai Chi intervention, while the other half will receive the conventional exercise intervention. Both groups will receive the same eduction and support during pulmonary rehabilitation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tai Chi | Experimental | Behavioral: Tai chi12 week Tai chi intervention, 3 sessions per week, 90 minutes per session |
| Conventional exercise | Active comparator | Behavioral: Conventional exercise12 week conventional exercise intervention, 3 sessions per week, 90 minutes per session |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- FEV1 between 30 and 80% of the predicted normal values
- FEV1/FVC ratio < 70%
Key exclusion criteria (5 listed)
- Patients with very severe COPD (GOLD IV);
- Patients that had a COPD exacerbations within the preceding 2 weeks of the baseline assessments;
- Significant hypoxemia at rest or during exercise (SpO2 <85%);
- Already following a rehabilitation program;
- Have physical limitations that compromises participation to a Tai chi and a conventional exercise program
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 | Tai Chi |
| Conventional exercise | Behavioural | Conventional exercise |
Primary outcome
Change from baseline dyspnea at 12 weeks
Time frame: Baseline, 12 weeks
Dyspnea will be assessed using the chronic respiratory questionnaire (CRQ)
10 secondary outcomes
Change from baseline lung function at week 12 (Spirometry and whole-body plethysmography)
Time frame: Baseline, 12 weeks
Change from baseline walking distance at 12 weeks (distance walked during the six-minute walk test)
Time frame: Baseline, 12 weeks
Change from baseline exercise capacity at 12 weeks(Endurance time during a constant work rate bicycle ergometry exercise test)
Time frame: Baseline, 12 weeks
Change from baseline isokinetic quadriceps muscle function at 12 weeks
Time frame: Baseline, 12 weeks
Change from baseline isometric quadriceps muscle strength at 12 weeks (force of the dominant quadriceps will be measured during a single magnetic stimulation of the femoral nerve)
Time frame: Baseline, 12 weeks
Change from baseline physical activity at 12 weeks (participants will be equipped with a physical activity monitor)
Time frame: Baseline, 12 weeks
Change from baseline quality of life (QoL) at 12 weeks
Time frame: Baseline, 12 weeks
Change from baseline health status at 12 weeks (determined with the COPD Assessment test (CAT).
Time frame: Baseline, 12 weeks
Change from baseline balance (Berg Balance Test (BBT) at 12 weeks
Time frame: Baseline, 12 weeks
Change from baseline of composite serum and plasma biomarkers at 12 weeks
Time frame: Baseline, 12 weeks
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 24 Apr 2018.
Related trials for Chronic Obstructive Pulmonary Disease (COPD)
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic Obstructive
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.
François Maltais, MD, PhD principal investigator
Francois.Maltais@fmed.ulaval.ca
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tai chi and Conventional exercise in people with Chronic Obstructive Pulmonary Disease (COPD), run by Laval University at 1 site in Canada.
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 2 inclusion and 5 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 24 Apr 2018. 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 Canada. 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.
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?
Change from baseline dyspnea at 12 weeks (time frame: Baseline, 12 weeks). 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 24 Apr 2018.