Effect of Baduanjin exercise of obstructive sleep apnea-hypopnea in chronic obstructive pulmonary disease: a study protocol for a randomized, single-blind, controlled trial

Background Baduanjin is one of the traditional Chinese treatments for respiratory diseases. However, its effects on overlap syndrome (obstructive sleep apnea-hypopnea and chronic obstructive pulmonary disease) have not been rigorously tested. This study aims to evaluate the benefits and safety of Baduanjin treatment in chronic obstructive pulmonary disease (COPD) patients with obstructive sleep apnea-hypopnea (OSAH). Methods COPD patients with OSAH will be randomly allocated in a 1:1 ratio to Baduanjin group or control group. Both groups receive continuous positive airway pressure therapy and basic medication for 12 weeks. Baduanjin group will receive additional instructional Baduanjin exercises. The primary outcomes are BODE index. The secondary outcomes are polysomnogram, cardiopulmonary exercise test, Beck Depression Scale-II, and Saint George’s Respiratory Questionnaire. Discussion This trial will provide preliminary evidence about the efficacy and safety of Baduanjin exercise for COPD patients with OSAH. Baduanjin exercises may become an additional option for pulmonary rehabilitation of OSA-COPD overlap syndrome. Trial registration [ClinicalTrials.gov][1], ID: NCT ChiCTR2200063171. Registered retrospectively on 1 June 2022. ### Competing Interest Statement The authors have declared that no competing interests exist. ### Clinical Trial ChiCTR2200063171. ### Funding Statement NO -The funders did not and will not have a role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The study received approval from ethics committee of Guangdong Provincial Hospital of Chinese Medicine (NO. BF2022-139-1). The investigator will explain the benefits and risks of trial participation to patients and their families, and written informed consent should be obtained before patients participate in the trial. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes All relevant data from this study will be made available upon study completion. * IPAP : inspired positive airway pressure EPAP : expiratory positive airway pressure CRF : Case Report Form BODE : B:Body Mass Index;O:Obstruction;D:Dyspnea;E:Exercise Capacity; SAS : Statistics Analysis System SPSS : Statistical Product and Service Solutions [1]: http://ClinicalTrials.gov