Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: State Key Laboratory of Respiratory Disease
Brief 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.


Options:
A: Arm Label: Healthy control subjects; Type: N/A; Interventions: N/A | Arm Label: Asymptomatic GOLD stage I COPD patients; Type: N/A; Interventions: Drug: Combination ipratropium/salbutamol or placebo (nebulization) | Arm Label: Symptomatic GOLD stage I COPD patients; Type: N/A; Interventions: Drug: Combination ipratropium/salbutamol or placebo (nebulization) | Intervention Type: DRUG; Name: Combination ipratropium/salbutamol or placebo (nebulization); Assigned to Arm(s): Asymptomatic GOLD stage I COPD patients, Symptomatic GOLD stage I COPD patients
B: Arm Label: Tai-Chi group; Type: ACTIVE_COMPARATOR; Interventions: Other: Tai-chi plus Indacaterol | Arm Label: Pulmonary rehabilitation group; Type: PLACEBO_COMPARATOR; Interventions: Other: Pulmonary rehabilitation plus Indacaterol | Intervention Type: OTHER; Name: Tai-chi plus Indacaterol; Assigned to Arm(s): Tai-Chi group | Intervention Type: OTHER; Name: Pulmonary rehabilitation plus Indacaterol; Assigned to Arm(s): Pulmonary rehabilitation group
C: Arm Label: Activity-Self Management; Type: EXPERIMENTAL; Interventions: Behavioral: Self-Management and Motivational Interviewing | Arm Label: Usual Care; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Self-Management and Motivational Interviewing; Assigned to Arm(s): Activity-Self Management
D: Arm Label: Aclidinium bromide; Type: EXPERIMENTAL; Interventions: Drug: Aclidinium Bromide | Arm Label: Placebo; Type: EXPERIMENTAL; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Aclidinium Bromide; Assigned to Arm(s): Aclidinium bromide | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo

Answer: B