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

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02370654
• Other study ID #: TCCOPD CER21009
• Status: Completed
• Phase: N/A
• First received: February 11, 2015
• Last updated: April 22, 2018
• Start date: March 2014
• Est. completion date: July 1, 2017

Study information

• Verified date: April 2018
• Source: Laval University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: July 1, 2017
• Est. primary completion date: July 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Behavioral:
• Tai chi

• Conventional exercise

Locations

Country	Name	City	State
Canada	Institut universitaire de cardiologie et de pneumologie de Québec	Quebec

Sponsors (3)

Lead Sponsor	Collaborator
Laval University	Maltais, Francois, M.D., Saey, Didier, M.D.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline dyspnea at 12 weeks	Dyspnea will be assessed using the chronic respiratory questionnaire (CRQ)	Baseline, 12 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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