NCT02370654

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

February 11, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 25, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

April 24, 2018

Status Verified

April 1, 2018

Enrollment Period

3.3 years

First QC Date

February 11, 2015

Last Update Submit

April 22, 2018

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

COPDTai chiPulmonary rehabilitation

Outcome Measures

Primary Outcomes (1)

  • Change from baseline dyspnea at 12 weeks

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

    Baseline, 12 weeks

Secondary Outcomes (10)

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

    Baseline, 12 weeks

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

    Baseline, 12 weeks

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

    Baseline, 12 weeks

  • Change from baseline isokinetic quadriceps muscle function at 12 weeks

    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)

    Baseline, 12 weeks

  • +5 more secondary outcomes

Study Arms (2)

Tai Chi

EXPERIMENTAL

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

Behavioral: Tai chi

Conventional exercise

ACTIVE COMPARATOR

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

Behavioral: Conventional exercise

Interventions

Tai chiBEHAVIORAL
Tai Chi
Conventional exerciseBEHAVIORAL
Conventional exercise

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • FEV1 between 30 and 80% of the predicted normal values
  • FEV1/FVC ratio \< 70%

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut universitaire de cardiologie et de pneumologie de Québec

Québec, G1V 4G5, Canada

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Tai Ji

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • François Maltais, MD, PhD

    Francois.Maltais@fmed.ulaval.ca

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc

Study Record Dates

First Submitted

February 11, 2015

First Posted

February 25, 2015

Study Start

March 1, 2014

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

April 24, 2018

Record last verified: 2018-04

Locations

CA(1)