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Completed

NCT Number: NCT02370654

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease (COPD) Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut universitaire de cardiologie et de pneumologie de Québec

Québec, G1V 4G5, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tai Chi

Behavioral

Conventional Exercise

Behavioral

Primary outcomes

  1. Change from baseline dyspnea at 12 weeks

    Time frame: Baseline, 12 weeks

    Dyspnea will be assessed using the chronic respiratory questionnaire (CRQ)

Secondary outcomes

  1. Change from baseline lung function at week 12 (Spirometry and whole-body plethysmography)

    Time frame: Baseline, 12 weeks

    Spirometry and whole-body plethysmography will be used for baseline and post-training (12 weeks) lung function testing.

  2. Change from baseline walking distance at 12 weeks (distance walked during the six-minute walk test)

    Time frame: Baseline, 12 weeks

    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.

  3. Change from baseline exercise capacity at 12 weeks(Endurance time during a constant work rate bicycle ergometry exercise test)

    Time frame: Baseline, 12 weeks

    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.

  4. Change from baseline isokinetic quadriceps muscle function at 12 weeks

    Time frame: Baseline, 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.

  5. 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)

    Time frame: Baseline, 12 weeks

    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).

  6. Change from baseline physical activity at 12 weeks (participants will be equipped with a physical activity monitor)

    Time frame: Baseline, 12 weeks

    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.

  7. Change from baseline quality of life (QoL) at 12 weeks

    Time frame: Baseline, 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.

  8. Change from baseline health status at 12 weeks (determined with the COPD Assessment test (CAT).

    Time frame: Baseline, 12 weeks

    Impact of COPD on a person's life will be determined with the COPD Assessment test (CAT).

  9. Change from baseline balance (Berg Balance Test (BBT) at 12 weeks

    Time frame: Baseline, 12 weeks

    The Berg Balance Test (BBT) will be used to evaluate the effect of the interventions on patient's balance.

  10. Change from baseline of composite serum and plasma biomarkers at 12 weeks

    Time frame: Baseline, 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.

Sponsors and collaborators

Lead sponsor

Laval University

Other

Collaborators

  • Maltais, Francois, M.D.
  • Saey, Didier, M.D.

Registry information

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Feb 25, 2015
Registry last updated
Apr 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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