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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
Sponsor:
Information provided by (Responsible Party):
Yuan-Ming Luo, State Key Laboratory of Respiratory Disease

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 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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation
Drug Information available for: Indacaterol

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




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


Information from the National Library of Medicine

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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
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.

Information from the National Library of Medicine

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


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Yuan-Ming Luo, State Key Laboratory of Respiratory Disease
ClinicalTrials.gov Identifier: NCT02665130     History of Changes
Other Study ID Numbers: CQAB149BCN01T
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

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

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases