Assessing the impact of diverse mask types on COPD patients: a randomised controlled trial study protocol
Hong Yang,
Shisan Bao,
Xuwen Chen,
Xiaomei Jiang,
Xuhui Zhang,
Dong Ren,
Caihong Wei,
Aihong Xu,
Ruijia Bai,
Caiyun Li,
Feiyan Yue,
Jungang Shi,
Jingchun Fan
Affiliations
Hong Yang
Ganzhou Institute of Medical Imaging, Ganzhou Key Laboratory of Medical Imaging and Artificial Intelligence, Medical Imaging Center, Ganzhou People`s Hospital, Ganzhou Hospital-Nanfang Hospital, Southern Medical University, Ganzhou, People`s Republic of China
Shisan Bao
Center for Laboratory and Simulation Training, School of Public Health, Center for Evidence-Based Medicine, Gansu University of Chinese Medicine, Lanzhou, Gansu, China
Xuwen Chen
Center for Laboratory and Simulation Training, School of Public Health, Center for Evidence-Based Medicine, Gansu University of Chinese Medicine, Lanzhou, Gansu, China
Xiaomei Jiang
Department of Psychosomatic and Sleep Medicine, Gansu Gem Flower Hospital, Lanzhou, Gansu, China
Xuhui Zhang
Department of Pulmonary Diseases, Affiliated Hospital of Gansu University of Chinese Medicine, Lanzhou, Gansu, China
Dong Ren
Department of Psychosomatic and Sleep Medicine, Gansu Gem Flower Hospital, Lanzhou, Gansu, China
Caihong Wei
Pulmonary and Critical Care Medicine, Gansu Gem Flower Hospital, Lanzhou, Gansu, China
Aihong Xu
Pulmonary and Critical Care Medicine, Gansu Gem Flower Hospital, Lanzhou, Gansu, China
Ruijia Bai
Department of Pulmonary Diseases, Affiliated Hospital of Gansu University of Chinese Medicine, Lanzhou, Gansu, China
Caiyun Li
Center for Laboratory and Simulation Training, School of Public Health, Center for Evidence-Based Medicine, Gansu University of Chinese Medicine, Lanzhou, Gansu, China
Feiyan Yue
Center for Laboratory and Simulation Training, School of Public Health, Center for Evidence-Based Medicine, Gansu University of Chinese Medicine, Lanzhou, Gansu, China
Jungang Shi
Pulmonary and Critical Care Medicine, Gansu Gem Flower Hospital, Lanzhou, Gansu, China
Jingchun Fan
Center for Laboratory and Simulation Training, School of Public Health, Center for Evidence-Based Medicine, Gansu University of Chinese Medicine, Lanzhou, Gansu, China
Introduction Wearing masks has proven beneficial in preventing respiratory pathogen infections in individuals with chronic obstructive pulmonary disease (COPD). However, the impact of different mask types on physiological indicators and daily physical activity in COPD patients remains uncertain. This study aims to assess the immediate effects of various mask types on cardiopulmonary function indicators, subjective perceptions and the 6-minute walking distance (6MWD) in individuals with COPD.Methods and analysis This randomised controlled trial will enrol 129 stable COPD patients. Participants will be randomly divided into three groups: control, N95 mask and surgical mask groups. Each group will undergo both a 6-minute seated test and a 6-minute walk test (6MWT), without or with their respective masks. A 10-minute interval will be provided between the two phases. The primary indicators of the study include the 6MWD and blood oxygen saturation. Secondary outcomes encompass blood pressure, pulse rate, Borg score, Rate of Perceived Exertion (RPE) score and subjective perception score. Oxygen saturation, pulse rate and blood pressure will be recorded four times during the trial, while Borg and RPE scores will be compared before and after the 6MWT. Additionally, subjective perception scores will be collected after each mask-wearing stage.Ethics and dissemination This study has received approval from the Ethics Committee of the Affiliated Hospital of Gansu University of Chinese Medicine (approval number: 202335). We plan to disseminate research results through publication in a peer-reviewed journal or presentation at a conference.Trial registration number ChiCTR2300074554.
