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

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD)

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Tai chi
Conventional exercise
Sponsored by
Laval University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring COPD, Tai chi, Pulmonary rehabilitation

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institut universitaire de cardiologie et de pneumologie de Québec

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Tai Chi

Conventional exercise

Arm Description

12 week Tai chi intervention, 3 sessions per week, 90 minutes per session

12 week conventional exercise intervention, 3 sessions per week, 90 minutes per session

Outcomes

Primary Outcome Measures

Change from baseline dyspnea at 12 weeks
Dyspnea will be assessed using the chronic respiratory questionnaire (CRQ)

Secondary Outcome Measures

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.
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.
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.
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.
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).
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.
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.
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).
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.
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.

Full Information

First Posted
February 11, 2015
Last Updated
April 22, 2018
Sponsor
Laval University
Collaborators
Saey, Didier, M.D., Maltais, Francois, M.D.
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1. Study Identification

Unique Protocol Identification Number
NCT02370654
Brief Title
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

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
July 1, 2017 (Actual)
Study Completion Date
July 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Laval University
Collaborators
Saey, Didier, M.D., Maltais, Francois, M.D.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD)
Keywords
COPD, Tai chi, Pulmonary rehabilitation

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tai Chi
Arm Type
Experimental
Arm Description
12 week Tai chi intervention, 3 sessions per week, 90 minutes per session
Arm Title
Conventional exercise
Arm Type
Active Comparator
Arm Description
12 week conventional exercise intervention, 3 sessions per week, 90 minutes per session
Intervention Type
Behavioral
Intervention Name(s)
Tai chi
Intervention Type
Behavioral
Intervention Name(s)
Conventional exercise
Primary Outcome Measure Information:
Title
Change from baseline dyspnea at 12 weeks
Description
Dyspnea will be assessed using the chronic respiratory questionnaire (CRQ)
Time Frame
Baseline, 12 weeks
Secondary Outcome Measure Information:
Title
Change from baseline lung function at week 12 (Spirometry and whole-body plethysmography)
Description
Spirometry and whole-body plethysmography will be used for baseline and post-training (12 weeks) lung function testing.
Time Frame
Baseline, 12 weeks
Title
Change from baseline walking distance at 12 weeks (distance walked during the six-minute walk test)
Description
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.
Time Frame
Baseline, 12 weeks
Title
Change from baseline exercise capacity at 12 weeks(Endurance time during a constant work rate bicycle ergometry exercise test)
Description
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.
Time Frame
Baseline, 12 weeks
Title
Change from baseline isokinetic quadriceps muscle function at 12 weeks
Description
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.
Time Frame
Baseline, 12 weeks
Title
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)
Description
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).
Time Frame
Baseline, 12 weeks
Title
Change from baseline physical activity at 12 weeks (participants will be equipped with a physical activity monitor)
Description
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.
Time Frame
Baseline, 12 weeks
Title
Change from baseline quality of life (QoL) at 12 weeks
Description
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.
Time Frame
Baseline, 12 weeks
Title
Change from baseline health status at 12 weeks (determined with the COPD Assessment test (CAT).
Description
Impact of COPD on a person's life will be determined with the COPD Assessment test (CAT).
Time Frame
Baseline, 12 weeks
Title
Change from baseline balance (Berg Balance Test (BBT) at 12 weeks
Description
The Berg Balance Test (BBT) will be used to evaluate the effect of the interventions on patient's balance.
Time Frame
Baseline, 12 weeks
Title
Change from baseline of composite serum and plasma biomarkers at 12 weeks
Description
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.
Time Frame
Baseline, 12 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
François Maltais, MD, PhD
Organizational Affiliation
Francois.Maltais@fmed.ulaval.ca
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut universitaire de cardiologie et de pneumologie de Québec
City
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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