title: Study design for a randomised controlled trial to explore the modality and mechanism of Tai Chi in the pulmonary rehabilitation of chronic obstructive pulmonary disease.
abstract: Although pulmonary rehabilitation (PR) is associated with significant clinical benefits in chronic obstructive pulmonary disease (COPD) and has been recommended by guidelines, PR with conventional exercise training has not been widely applied in the clinic because of its inherent limitations. Alternative exercise such as Tai Chi has been investigated and the results are promising. However, the strengths and weaknesses of the exercise modality of Tai Chi, conventional PR and a combination of Tai Chi and conventional PR and the possible mechanisms underlying Tai Chi exercise remain unclear. This study aims to address the above research gaps in a well-designed clinical trial.
  
  
  
  This study is a single-blind, randomised controlled trial. Participants with stable COPD will be recruited and randomly assigned to one of four groups receiving Tai Chi exercise, conventional PR using a total body recumbent stepper (TBRS), combined Tai Chi and TBRS, or usual care (control) in a 1:1:1:1 ratio. Participants will perform 30 min of supervised exercise three times a week for 8 weeks; they will receive sequential follow-ups until 12 months after recruitment. The primary outcome will be health-related quality of life as measured by the St George's Respiratory Questionnaire. Secondary outcomes will include 6 min walking distance, pulmonary function, the modified Medical Research Council Dyspnoea Scale, the COPD Assessment Test, the Hospital Anxiety and Depression Scale, the Berg Balance Scale, exacerbation frequency during the study period, and systemic inflammatory and immune markers.
  
  
  
  Ethics approval has been granted by the Clinical Trial and Biomedical Ethics Committee of West China Hospital of Sichuan University (No TCM-2015-82). Written informed consent will be obtained from each participant before any procedures are performed. The study findings will be published in peer-reviewed journals and presented at national and international conferences.
  
  
  
  ChiCTR-IOR-15006874; Pre-results.
authors: Respiratory Group, Department of Integrated Traditional Chinese and Western Medicine, West China Hospital, Sichuan University, Chengdu, China.
authors: Juan-Juan
authors: JJ
authors: Fu
authors: Respiratory Group, Department of Integrated Traditional Chinese and Western Medicine, West China Hospital, Sichuan University, Chengdu, China.
authors: Jie
authors: J
authors: Min
authors: Department of Rehabilitation, West China Hospital, Sichuan University, Chengdu, China.
authors: Peng-Ming
authors: PM
authors: Yu
authors: Priority Research Centre for Asthma and Respiratory Diseases, University of Newcastle, Newcastle, New South Wales, Australia Faculty of Health, School of Nursing and Midwifery, University of Newcastle, Newcastle, New South Wales, Australia.
authors: Vanessa M
authors: VM
authors: McDonald
authors: Respiratory Group, Department of Integrated Traditional Chinese and Western Medicine, West China Hospital, Sichuan University, Chengdu, China.
authors: Bing
authors: B
authors: Mao
mesh_terms: D000368:Aged; D002681:China; D005081:Exercise Therapy / Q000379:methods*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D029424:Pulmonary Disease, Chronic Obstructive / Q000534:rehabilitation*; D011788:Quality of Life; D012107:Research Design; D016037:Single-Blind Method; D011795:Surveys and Questionnaires; D026302:Tai Ji
keywords: Tai Chi; chronic obstructive pulmonary disease; pulmonary rehabilitation; randomized controlled trial; traditional Chinese medicine