Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
State Key Laboratory of Respiratory Disease
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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