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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.
BMJ Open. 2016 08 04; 6(8):e011297.BO

Abstract

INTRODUCTION

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.

METHODS AND ANALYSIS

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 AND DISSEMINATION

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.

TRIAL REGISTRATION NUMBER

ChiCTR-IOR-15006874; Pre-results.

Authors+Show Affiliations

Respiratory Group, Department of Integrated Traditional Chinese and Western Medicine, West China Hospital, Sichuan University, Chengdu, China.Respiratory Group, Department of Integrated Traditional Chinese and Western Medicine, West China Hospital, Sichuan University, Chengdu, China.Department of Rehabilitation, West China Hospital, Sichuan University, Chengdu, China.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.Respiratory Group, Department of Integrated Traditional Chinese and Western Medicine, West China Hospital, Sichuan University, Chengdu, China.

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

27491669

Citation

Fu, Juan-Juan, et al. "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." BMJ Open, vol. 6, no. 8, 2016, pp. e011297.
Fu JJ, Min J, Yu PM, et al. 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. BMJ Open. 2016;6(8):e011297.
Fu, J. J., Min, J., Yu, P. M., McDonald, V. M., & Mao, B. (2016). 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. BMJ Open, 6(8), e011297. https://doi.org/10.1136/bmjopen-2016-011297
Fu JJ, et al. 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. BMJ Open. 2016 08 4;6(8):e011297. PubMed PMID: 27491669.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Fu,Juan-Juan, AU - Min,Jie, AU - Yu,Peng-Ming, AU - McDonald,Vanessa M, AU - Mao,Bing, Y1 - 2016/08/04/ PY - 2016/8/6/entrez PY - 2016/8/6/pubmed PY - 2017/12/26/medline KW - Tai Chi KW - chronic obstructive pulmonary disease KW - pulmonary rehabilitation KW - randomized controlled trial KW - traditional Chinese medicine SP - e011297 EP - e011297 JF - BMJ open JO - BMJ Open VL - 6 IS - 8 N2 - INTRODUCTION: 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. METHODS AND ANALYSIS: 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 AND DISSEMINATION: 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. TRIAL REGISTRATION NUMBER: ChiCTR-IOR-15006874; Pre-results. SN - 2044-6055 UR - https://www.unboundmedicine.com/medline/citation/27491669/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_ L2 - https://bmjopen.bmj.com/lookup/pmidlookup?view=long&pmid=27491669 DB - PRIME DP - Unbound Medicine ER -