Chen-style Tai Chi in Pulmonary Rehabilitation for Chronic Obstructive Pulmonary Disease

Study Overview
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Brief Summary
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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.

Official Title
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Chen-style Tai Chi in Pulmonary Rehabilitation for Chronic Obstructive Pulmonary Disease

Conditions
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Chronic Obstructive Pulmonary Disease (COPD)

Intervention / Treatment
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* Behavioral: Tai chi
* Behavioral: Conventional exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: FEV1 between 30 and 80% of the predicted normal values FEV1/FVC ratio < 70% Exclusion Criteria: 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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tai Chi<br>12 week Tai chi intervention, 3 sessions per week, 90 minutes per session | Behavioral: Tai chi<br> <br> |
| Active Comparator: Conventional exercise<br>12 week conventional exercise intervention, 3 sessions per week, 90 minutes per session | Behavioral: Conventional exercise<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline dyspnea at 12 weeks | Dyspnea will be assessed using the chronic respiratory questionnaire (CRQ) | Baseline, 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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). | 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. | 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. | 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). | 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. | 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. | Baseline, 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, Tai chi, Pulmonary rehabilitation