Effects of combining acupuncture with exercise training on relieving dyspnea and improving exercise tolerance in chronic obstructive pulmonary disease patients: a protocol for a single-blind, randomized, sham-controlled trial.

BACKGROUND

Exercise training is beneficial for patients with chronic obstructive pulmonary disease (COPD). However, the effect of exercise training is limited by patients' impaired exercise capacity, exertional dyspnea and other respiratory problems. Acupuncture, as a reliable and safe therapy, is effective in reducing dyspnea, relieving respiratory muscle fatigue, and improving exercise capacity of COPD patients. However, it is not known whether the combination of exercise training and acupuncture reduces dyspnea and improves quality of life of COPD patients or induces more pronounced effects in dyspnea and exercise tolerance. This trial aims to determine whether acupuncture enhances the effect of exercise training in COPD patients compared to sham acupuncture.

METHODS

In this single-blind, randomized, sham-controlled trial, 70 COPD patients will be enrolled and randomly assigned (1:1) to the following 2 groups: (I) real acupuncture and exercise training group; and (II) sham acupuncture and exercise training group. For acupoint selection, CV 4, CV 12, CV 17, ST 40, ST 16 and ST 25 will be used for all patients. For sham acupuncture group, Streitberger placebo needles will be used. A single-blind method will be adopted in this trial. Data collectors and statisticians will be blinded in this trial, only the acupuncturists will know the group allocation. The intervention will be conducted 3 times a week for 8 weeks, totaling 24 treatments. Patients will be evaluated at the baseline, after 14 treatments during the 5th week, after 24 treatments during the 8th week, and at a 5-month follow-up period. The primary outcomes will be assessed by a modified British medical research council questionnaire (mMRC), COPD assessment test (CAT), and 6-minute walk test (6MWT). The secondary outcomes will be measured by changes in variables from the lung function test, cardiopulmonary exercise testing, and blood gas analysis. Two-independent sample t-tests will be used to compare differences in the changes in all outcome measures after the intervention between two groups. Safety evaluation will be performed at each treatment visit and assessment by recording adverse events (AE) in the AE Report Form.

DISCUSSION

This study will help to determine whether acupuncture increases the benefits obtained from exercise training in COPD patients.

TRIAL REGISTRATION

Chinese Clinical Trial Registry: ChiCTR1900028627. Registered on December 29, 2019.