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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

State Key Laboratory of Respiratory Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02665130
• Other study ID #: CQAB149BCN01T
• Status: Completed
• Phase: Phase 4
• First received: October 28, 2015
• Last updated: October 12, 2016
• Start date: December 2014
• Est. completion date: August 2016

Study information

• Verified date: October 2016
• Source: State Key Laboratory of Respiratory Disease
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

1. bronchodilator naïve patients

2. 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)

3. patients who are residents in Xingning city (Guangdong Province, China) will be recruited.

Exclusion Criteria:

1. Patients currently or previous on any type of Tai Chi exercise or pulmonary rehabilitation

2. Patients with a history of malignancy of any organ system treated or untreated, within the past 5 years.

3. Patients with clinically significant renal, cardiovascular, neurological, metabolism, immunological, psychiatric, gastrointestinal, hepatic, or haematological abnormalities.

4. Patients with concomitant pulmonary disease (e.g. asthma, lung fibrosis, primary bronchiectasis, sarcoidosis, interstitial lung disorder, tuberculosis)

5. Patients with obesity (BMI> 40 kg/m2).

6. Patients requiring long term oxygen therapy (> 12 h a day) on a daily basis for chronic hypoxemia or recovering from acute exacerbation less than 6 weeks.

7. Patients with Asthma.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• Tai-chi plus Indacaterol
Participants perform Tai-chi exercise 5 days/week and take indacaterol 150ug/day for 24 weeks
• Pulmonary rehabilitation plus Indacaterol
Participants perform conventional exercise 5 days/week and take indacaterol 150ug/day for 24 weeks

Locations

Country	Name	City	State
China	Xing-Ning Hospital	Meizhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Yuan-Ming Luo

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in St. George's Respiratory Questionnaire (SGRQ)		14 weeks after intervention	No