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

• ClinicalTrials.gov Identifier: NCT02665130
• Recruitment Status: Completed
• First Posted: January 27, 2016
• Last Update Posted: October 13, 2016
• Sponsor: Yuan-Ming Luo
• Information provided by (Responsible Party): Yuan-Ming Luo, State Key Laboratory of Respiratory Disease

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Chronic Obstructive Pulmonary Disease	Other: Tai-chi plus Indacaterol; Other: Pulmonary rehabilitation plus Indacaterol	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: State Key Laboratory of Respiratory Disease
• Study Start Date: December 2014
• Actual Primary Completion Date: August 2016
• Actual Study Completion Date: August 2016

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Tai-Chi group; Tai-Chi exercise plus Indacaterol 150ug/day	Other: Tai-chi plus Indacaterol; Participants perform Tai-chi exercise 5 days/week and take indacaterol 150ug/day for 24 weeks
Placebo Comparator: Pulmonary rehabilitation group; Conventional exercise plus Indacaterol 150ug/day	Other: Pulmonary rehabilitation plus Indacaterol; Participants perform conventional exercise 5 days/week and take indacaterol 150ug/day for 24 weeks

Outcome Measures

Primary Outcome Measures :

1. change in St. George's Respiratory Questionnaire (SGRQ) [ Time Frame: 14 weeks after intervention ]

Eligibility Criteria

• Ages Eligible for Study: 40 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

China, Guangdong

Xing-Ning Hospital

Meizhou, Guangdong, China

Sponsors and Collaborators

Yuan-Ming Luo

Investigators

• Principal Investigator: Yuan-Ming Luo, PhD; The Affiliated Hospital og Guangzhou Medical University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Polkey MI, Qiu ZH, Zhou L, Zhu MD, Wu YX, Chen YY, Ye SP, He YS, Jiang M, He BT, Mehta B, Zhong NS, Luo YM. Tai Chi and Pulmonary Rehabilitation Compared for Treatment-Naive Patients With COPD: A Randomized Controlled Trial. Chest. 2018 May;153(5):1116-1124. doi: 10.1016/j.chest.2018.01.053. Epub 2018 Apr 3.

• Responsible Party: Yuan-Ming Luo, State Key Laboratory of Respiratory Disease
• ClinicalTrials.gov Identifier: NCT02665130
• Other Study ID Numbers: CQAB149BCN01T
• First Posted: January 27, 2016
• Last Update Posted: October 13, 2016
• Last Verified: October 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes

Keywords provided by Yuan-Ming Luo, State Key Laboratory of Respiratory Disease:

COPD; Pulmonary rehabilitation

Additional relevant MeSH terms:

Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Lung Diseases; Respiratory Tract Diseases