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临床试验/NCT02665130
NCT02665130已完成4 期

State Key Laboratory of Respiratory Disease

Yuan-Ming Luo1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2014年12月1日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
120
试验地点
1
主要终点
change in St. George's Respiratory Questionnaire (SGRQ)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

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

时间窗: 14 weeks after intervention

次要结局

未报告次要终点

研究者

发起方
Yuan-Ming Luo
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Yuan-Ming Luo

State Key Laboratory of Respiratory Disease

State Key Laboratory of Respiratory Disease

研究点 (1)

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