Comparison of Tai Chi and Pulmonary Rehabilitation on the Effect of Indacaterol in Treatment naïve COPD Participants
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|ClinicalTrials.gov Identifier: NCT02665130|
Recruitment Status : Completed
First Posted : January 27, 2016
Last Update Posted : October 13, 2016
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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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- change in St. George's Respiratory Questionnaire (SGRQ) [ Time Frame: 14 weeks after intervention ]
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|Ages Eligible for Study:||40 Years to 80 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02665130
|Meizhou, Guangdong, China|
|Principal Investigator:||Yuan-Ming Luo, PhD||The Affiliated Hospital og Guangzhou Medical University|
|Responsible Party:||Yuan-Ming Luo, State Key Laboratory of Respiratory Disease|
|Other Study ID Numbers:||
|First Posted:||January 27, 2016 Key Record Dates|
|Last Update Posted:||October 13, 2016|
|Last Verified:||October 2016|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases