MedTrace Logo

Comparison of Tai Chi and Pulmonary Rehabilitation on the Effect of Indacaterol in Treatment naïve COPD Participants

NCT02665130 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2016-10-13

No results posted yet for this study

Summary

Tai-Chi may be a beneficial form of rehabilitation which is acceptable to the Chinese population but no data exist concerning metabolic responses to Tai-Chi in COPD patients. Investigators conduct an Randomized controlled trial to evaluate the synergistic effect of a Long acting β2-agonists with Tai-Chi as a culturally acceptable form of PR in the Asian population. Classical western style pulmonary rehabilitation will serve as a comparator Investigators propose a prospective randomized controlled trial in which 120 bronchodilator naïve participants (Age 40-80 with GOLD II-IV COPD (post-bronchodilator FEV1 ≥ 25% and \<80 % of the predicted normal, and a post-bronchodilator FEV1/FVC \< 0.70) are randomized to receive a 26 weeks course of Indacaterol with either Tai-Chi or conventional Pulmonary Rehabilitation. Only participants who are residents in Xingning city (Guangdong Province, China) will be recruited.

Both Tai-Chi and pulmonary rehabilitation will be given by qualified instructors at a rural location in southern China (Xingning). A qualified UK Physiotherapist will also be involved in the management of pulmonary rehabilitation program to further make sure the high quality of pulmonary rehabilitation has been applied. Both arm participants will also receive in an open label fashion Indacaterol 150µg qd. for 6 months giving 2 therapy groups (Tai-Chi/Indacaterol, pulmonary rehabilitation/Indacaterol). The primary endpoint of this study is change in SGRQ between Tai-Chi/Indacaterol and pulmonary rehabilitation/Indacaterol at 14 weeks after entry and the secondary endpoints are change in FEV1% and six minute walk distance. the planned recruitment will be 120 with a view to obtaining 100 completers. The investigators propose the study starts on 31 Dec 2014 and completes on 30 June, 2016.

Conditions

Interventions

OTHER

Tai-chi plus Indacaterol

Participants perform Tai-chi exercise 5 days/week and take indacaterol 150ug/day for 24 weeks

OTHER

Pulmonary rehabilitation plus Indacaterol

Participants perform conventional exercise 5 days/week and take indacaterol 150ug/day for 24 weeks

Sponsors & Collaborators

  • Yuan-Ming Luo

    lead OTHER

Principal Investigators

  • Yuan-Ming Luo, PhD · The Affiliated Hospital og Guangzhou Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2016-08-31
Completion
2016-08-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02665130 on ClinicalTrials.gov