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. 2019 Jan 11;20(1):41.
doi: 10.1186/s13063-018-3149-7.

Effects of home-based prescribed pulmonary exercise by patients with chronic obstructive pulmonary disease: study protocol for a randomized controlled trial

Xiaodan Liu  1   2 , Peijun Li  3 , Lu Xiao  1 , Yufan Lu  3 , Ning Li  3 , Zhengrong Wang  3 , Hongxia Duan  1 , Jian Li  3 , Weibing Wu  4
Affiliations

Effects of home-based prescribed pulmonary exercise by patients with chronic obstructive pulmonary disease: study protocol for a randomized controlled trial

Xiaodan Liu et al. Trials. .

Abstract

Background: Chronic obstructive pulmonary disease (COPD) not only affects pulmonary function but also leads to skeletal muscle dysfunction. The various characteristics of different forms of traditional Chinese exercise lead to inconsistent clinical effects in COPD patients. Hence, the present study carefully combined and rearranged liuzijue, wuqinxi, baduanjin, and yijinjing into a pulmonary exercise program targeting COPD patients.

Methods/design: This study is a single-blind, randomized controlled trial. A random number table will be generated by an independent person. Each number will be placed in a sealed opaque envelop to blind assignment. All outcome assessors will be blinded to group assignment. COPD patients between 40 and 80 years of age, with stable medical treatment and no regular participation in regular exercise in the last 6 months will be included. All participants will be recruited from the Respiratory Medicine Department of Yue-Yang Integrative Medicine Hospital Affiliated to Shanghai University of Traditional Chinese Medicine. All participants will continue to follow their medical treatment. They will be randomly assigned to one of four groups in a 1:1:1:1 ratio: (1) usual care (control group, CG), (2) pulmonary exercise group (PG), (3) resistance exercise group (RG), or (4) combined pulmonary exercise and resistance exercise group (PRG). CG participants will receive medical treatment only. PG participants will perform 60 min of exercise twice a day 7 days a week for 3 months, with 1 day's exercise per week at hospital under guidance and supervision. RG participants will perform 60 min of resistance exercise once a day, three times a week for 3 months, with 1 day's exercise per week at hospital under guidance and supervision. PRG participants will perform 60 min of prescribed pulmonary exercise combined with resistance exercise for 3 months. The outcomes include the isokinetic strength of peripheral skeletal muscle, surface electromyography, 6-min walking distance, 30-s arm curl test, pulmonary function, respiratory muscle strength, dyspnea, body composition, physical activity, quality of life, and Chronic Disease Self-Efficacy Scale.

Discussion: The results of this study will compensate for the current inadequate understanding of prescribed pulmonary exercise and may provide a new, simple, convenient, and effective home-based exercise intervention for COPD patients.

Trial registration: Chinese Clinical Trial Registry, ChiCTR-1800017405 . Registered on 28 July 2018.

Keywords: COPD; home-based rehabilitation; prescribed pulmonary exercise; resistance exercise; skeletal muscle function.

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Conflict of interest statement

Ethics approval and consent to participate

The patients will be informed both in writing and verbally about the purpose and details of the study and all patients enrolled will provide written consent. The study has been approved by the Ethics Committee of Yue-Yang Integrative Medicine Hospital, Affiliated with Shanghai University of Traditional Chinese Medicine (Shanghai, China). Any changes or amendments to the protocol will be reported to the Ethics Committee of Yue-Yang Integrative Medicine Hospital according to guidelines and to the Chinese Clinical Trial Registry.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Main characteristics of pulmonary exercise. The picture is from the “Teaching video of COPD patient pulmonary exercise” self-recorded by the research group. The teacher in the video is Xiaodan Liu, a member of the research group. (a) Rise-up position. (b) “hu” sound. (c) “si” sound. (d) Pushing up the sky to regulate the triple warmer. (e) Drawing a bow to shoot a vulture. (f) Crane actions, including the crane spreading its wings and flying. (g) Cross-armed iron staff. (h) Restore position
Fig. 2
Fig. 2
Study flow chart. 6MWT 6-min walking test, CG control group, COPD chronic obstructive pulmonary disease, mMRC Modified Medical Research Council Dyspnea Scale, PASE Physical Activity Scale for the Elderly, PG pulmonary exercise group, PRG pulmonary exercise and resistance exercise group, RG resistance exercise group, sEMG surface electromyography, SES Chronic Disease Self-Efficacy Scale, SGRQ St. George’s Respiratory Questionnaire
Fig. 3
Fig. 3
SPIRIT figure showing time points for enrollment, interventions and assessment. PE pulmonary exercise, RE resistance exercise. *Baseline characteristics include pulmonary function assessed by spirometry, dyspnea assessed by the Modified Medical Research Council Dyspnea Scale, body composition assessed by dual-energy X-ray absorptiometry, and height and weight assessed by a body tester. **Muscle function test includes respiratory muscle strength assessed by spirometry, dominant upper and lower limb muscle strength assessed by a CON-TREX isokinetic dynamometer and by a wireless remote-sensing surface electromyography and analysis system. ***Exercise capacity test includes 30-s arm curl test and 6-min walking test. ****Questionnaire includes St. George’s Respiratory Questionnaire, the Physical Activity Scale for the Elderly, and the Chronic Disease Self-Efficacy Scale
See this image and copyright information in PMC

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