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

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 Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Intervention / Treatment: Behavioral: Tai chi; Behavioral: Conventional exercise

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada, G1V 4G5
    • Institut Universitaire de cardiologie et de pneumologie de Quebec

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Laval University
• Collaborators: Maltais, Francois, M.D.; Saey, Didier, M.D.
• Investigators: Principal Investigator: François Maltais, MD, PhD, Francois.Maltais@fmed.ulaval.ca

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): July 1, 2017
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: February 11, 2015
• First Submitted That Met QC Criteria: February 18, 2015
• First Posted (Estimate): February 25, 2015

Study Record Updates

• Last Update Posted (Actual): April 24, 2018
• Last Update Submitted That Met QC Criteria: April 22, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: COPD; Pulmonary rehabilitation; Tai chi
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: TCCOPD CER21009