Clinical trial NCT02370654: Chen-style Tai Chi in Pulmonary Rehabilitation for Chronic Obstructive Pulmonary Disease
Official title: Chen-style Tai Chi in Pulmonary Rehabilitation for Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: COPD
Tai chi
Pulmonary rehabilitation
Lead sponsor: Laval University
Sponsor class: OTHER
Collaborators: name: Saey, Didier, M.D.
name: Maltais, Francois, M.D.
First posted: 2015-02-25
Enrollment: 44
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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. Both groups will receive the same eduction and support during pulmonary rehabilitation.


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline dyspnea at 12 weeks
timeFrame: Baseline, 12 weeks
Secondary outcomes:
measure: Change from baseline lung function at week 12 (Spirometry and whole-body plethysmography)
timeFrame: Baseline, 12 weeks
measure: Change from baseline walking distance at 12 weeks (distance walked during the six-minute walk test)
timeFrame: Baseline, 12 weeks
measure: Change from baseline exercise capacity at 12 weeks(Endurance time during a constant work rate bicycle ergometry exercise test)
timeFrame: Baseline, 12 weeks
measure: Change from baseline isokinetic quadriceps muscle function at 12 weeks
timeFrame: Baseline, 12 weeks
measure: 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)
timeFrame: Baseline, 12 weeks
measure: Change from baseline physical activity at 12 weeks (participants will be equipped with a physical activity monitor)
timeFrame: Baseline, 12 weeks
measure: Change from baseline quality of life (QoL) at 12 weeks
timeFrame: Baseline, 12 weeks
measure: Change from baseline health status at 12 weeks (determined with the COPD Assessment test (CAT).
timeFrame: Baseline, 12 weeks
measure: Change from baseline balance (Berg Balance Test (BBT) at 12 weeks
timeFrame: Baseline, 12 weeks
measure: Change from baseline of composite serum and plasma biomarkers at 12 weeks
timeFrame: Baseline, 12 weeks
Other outcomes:
Locations:
city: Quebec
country: Canada
facility: Institut universitaire de cardiologie et de pneumologie de Québec
Study officials:
affiliation: Francois.Maltais@fmed.ulaval.ca
name: François Maltais, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: