Assessing the impact of diverse mask types on COPD patients: a randomised controlled trial study protocol
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. Thi...
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BMJ Publishing Group
2024-01-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/14/1/e080721.full |
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| author | 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 |
| author_facet | 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 |
| author_sort | Hong Yang |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-0e507622df1241da9aa580be3169c1fb |
| institution | OA Journals |
| issn | 2044-6055 |
| language | English |
| publishDate | 2024-01-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-0e507622df1241da9aa580be3169c1fb2025-08-20T02:13:32ZengBMJ Publishing GroupBMJ Open2044-60552024-01-0114110.1136/bmjopen-2023-080721Assessing the impact of diverse mask types on COPD patients: a randomised controlled trial study protocolHong Yang0Shisan Bao1Xuwen Chen2Xiaomei Jiang3Xuhui Zhang4Dong Ren5Caihong Wei6Aihong Xu7Ruijia Bai8Caiyun Li9Feiyan Yue10Jungang Shi11Jingchun Fan12KTH Royal Institute of Technology, Solna, Stockholm, SwedenCenter for Laboratory and Simulation Training, School of Public Health, Center for Evidence-Based Medicine, Gansu University of Chinese Medicine, Lanzhou, Gansu, ChinaCenter for Laboratory and Simulation Training, School of Public Health, Center for Evidence-Based Medicine, Gansu University of Chinese Medicine, Lanzhou, Gansu, China1 Social Medicine Center, National Research Institute for Family Planning, Beijing, ChinaDepartment of Pulmonary Diseases, Affiliated Hospital of Gansu University of Chinese Medicine, Lanzhou, Gansu, ChinaDepartment of Psychosomatic and Sleep Medicine, Gansu Gem Flower Hospital, Lanzhou, Gansu, ChinaPulmonary and Critical Care Medicine, Gansu Gem Flower Hospital, Lanzhou, Gansu, ChinaPulmonary and Critical Care Medicine, Gansu Gem Flower Hospital, Lanzhou, Gansu, ChinaDepartment of Pulmonary Diseases, Affiliated Hospital of Gansu University of Chinese Medicine, Lanzhou, Gansu, ChinaCenter for Laboratory and Simulation Training, School of Public Health, Center for Evidence-Based Medicine, Gansu University of Chinese Medicine, Lanzhou, Gansu, ChinaCenter for Laboratory and Simulation Training, School of Public Health, Center for Evidence-Based Medicine, Gansu University of Chinese Medicine, Lanzhou, Gansu, ChinaPulmonary and Critical Care Medicine, Gansu Gem Flower Hospital, Lanzhou, Gansu, ChinaCenter for Laboratory and Simulation Training, School of Public Health, Center for Evidence-Based Medicine, Gansu University of Chinese Medicine, Lanzhou, Gansu, ChinaIntroduction 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.https://bmjopen.bmj.com/content/14/1/e080721.full |
| spellingShingle | 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 Assessing the impact of diverse mask types on COPD patients: a randomised controlled trial study protocol BMJ Open |
| title | Assessing the impact of diverse mask types on COPD patients: a randomised controlled trial study protocol |
| title_full | Assessing the impact of diverse mask types on COPD patients: a randomised controlled trial study protocol |
| title_fullStr | Assessing the impact of diverse mask types on COPD patients: a randomised controlled trial study protocol |
| title_full_unstemmed | Assessing the impact of diverse mask types on COPD patients: a randomised controlled trial study protocol |
| title_short | Assessing the impact of diverse mask types on COPD patients: a randomised controlled trial study protocol |
| title_sort | assessing the impact of diverse mask types on copd patients a randomised controlled trial study protocol |
| url | https://bmjopen.bmj.com/content/14/1/e080721.full |
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