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

NCT02665130 | Completed Phase 4 DMC

• 1 other identifier: CQAB149BCN01T
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD; Pulmonary rehabilitation

Outcome Measures

Primary Outcomes (1)

• change in St. George's Respiratory Questionnaire (SGRQ)

  14 weeks after intervention

Study Arms (2)

Tai-Chi group

ACTIVE COMPARATOR

Tai-Chi exercise plus Indacaterol 150ug/day

Other: Tai-chi plus Indacaterol

Pulmonary rehabilitation group

PLACEBO COMPARATOR

Conventional exercise plus Indacaterol 150ug/day

Other: Pulmonary rehabilitation plus Indacaterol

Interventions

Tai-chi plus Indacaterol OTHER

Participants perform Tai-chi exercise 5 days/week and take indacaterol 150ug/day for 24 weeks

Tai-Chi group

Pulmonary rehabilitation plus Indacaterol OTHER

Participants perform conventional exercise 5 days/week and take indacaterol 150ug/day for 24 weeks

Pulmonary rehabilitation group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients currently or previous on any type of Tai Chi exercise or pulmonary rehabilitation
• Patients with a history of malignancy of any organ system treated or untreated, within the past 5 years.
• Patients with clinically significant renal, cardiovascular, neurological, metabolism, immunological, psychiatric, gastrointestinal, hepatic, or haematological abnormalities.
• Patients with concomitant pulmonary disease (e.g. asthma, lung fibrosis, primary bronchiectasis, sarcoidosis, interstitial lung disorder, tuberculosis)
• Patients with obesity (BMI\> 40 kg/m2).
• 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.
• Patients with Asthma.

Sponsors & Collaborators

• Yuan-Ming Luo: lead

Study Sites (1)

Xing-Ning Hospital

Meizhou, Guangdong, China

Location

Related Publications (1)

• 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.

  PMID: 29625777 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Tai Ji; indacaterol

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Yuan-Ming Luo, PhD

  The Affiliated Hospital og Guangzhou Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: State Key Laboratory of Respiratory Disease

Study Record Dates

• First Submitted: October 28, 2015
• First Posted: January 27, 2016
• Study Start: December 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: October 13, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)