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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Other: Tai-chi plus Indacaterol; Other: Pulmonary rehabilitation plus Indacaterol

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Meizhou, Guangdong, China
      • Xing-Ning Hospital

Participation Criteria

Eligibility Criteria

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

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
change in St. George's Respiratory Questionnaire (SGRQ)	14 weeks after intervention

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: October 28, 2015
• First Submitted That Met QC Criteria: January 22, 2016
• First Posted (Estimate): January 27, 2016

Study Record Updates

• Last Update Posted (Estimate): October 13, 2016
• Last Update Submitted That Met QC Criteria: October 12, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: COPD; Pulmonary rehabilitation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: CQAB149BCN01T

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES