EXamining the feasibility of exerCisE to manage symptoms of Lupus (EXCEL): a protocol for a randomised controlled pilot study
Introduction SLE is a chronic autoimmune disease that results in sustained hyperactivation of innate and adaptive immune cells and widespread inflammatory damage. Regular exercise reduces SLE symptoms including fatigue and joint pain and improves patient quality of life. However, most individuals wi...
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| Format: | Article |
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BMJ Publishing Group
2025-01-01
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| Series: | Lupus Science and Medicine |
| Online Access: | https://lupus.bmj.com/content/12/1/e001382.full |
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| author | John Reynolds Katie Hesketh Matthew Cocks Megan Quickfall Alex J Wadley Scott Green Jet Veldhuijzen Van Zanten |
| author_facet | John Reynolds Katie Hesketh Matthew Cocks Megan Quickfall Alex J Wadley Scott Green Jet Veldhuijzen Van Zanten |
| author_sort | John Reynolds |
| collection | DOAJ |
| description | Introduction SLE is a chronic autoimmune disease that results in sustained hyperactivation of innate and adaptive immune cells and widespread inflammatory damage. Regular exercise reduces SLE symptoms including fatigue and joint pain and improves patient quality of life. However, most individuals with SLE are not sufficiently active to achieve these benefits, and guidance on the optimal approach to exercise is limited. EXCEL will examine the feasibility of conducting a large-scale randomised controlled trial comparing the effects of a remotely monitored, home-based, exercise programme with standard of care for individuals with SLE.Methods and analysis 30 females with SLE will be recruited, and those randomised into Exercise (SLE-Ex) will codesign a progressive training plan with support from the research team. The aim of each 12-week plan will be to complete 150 min of moderate (60–70% heart rate max, HRmax) or 90 min of vigorous exercise (>70% HRmax) per week. SLE-Ex will be encouraged to exercise independently (without support) from weeks 13–18. Participants with SLE that are randomised into Control (SLE-Con) will maintain habitual activity without support for 18 weeks. Measures of feasibility and acceptability will be reported, and peripheral blood will be collected at weeks 0, 12 and 18 to explore whether the frequency, phenotype and metabolic profile of lymphocyte subsets has changed. Biomarkers of SLE activity, and self-reported measures of fatigue, sleep quality and health-related quality of life will also be monitored at these timepoints. Blood and self-reported measures will be compared with a healthy control (HC) group (n=15, age and body mass index matched) at baseline only.Ethics and dissemination A favourable ethical opinion was given by South East Scotland Research Ethics Committee (22/SS/0082). Findings will be disseminated at conferences and published in peer-reviewed journals.Trial registration number ISRCTN72757645. |
| format | Article |
| id | doaj-art-5aa668439deb45b282499b165dd2125d |
| institution | Kabale University |
| issn | 2053-8790 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | Lupus Science and Medicine |
| spelling | doaj-art-5aa668439deb45b282499b165dd2125d2025-01-18T04:20:10ZengBMJ Publishing GroupLupus Science and Medicine2053-87902025-01-0112110.1136/lupus-2024-001382EXamining the feasibility of exerCisE to manage symptoms of Lupus (EXCEL): a protocol for a randomised controlled pilot studyJohn Reynolds0Katie Hesketh1Matthew Cocks2Megan Quickfall3Alex J Wadley4Scott Green5Jet Veldhuijzen Van Zanten6Institute of Inflammation and Ageing, University of Birmingham, Birmingham, UKSchool of Sport, Exercise and Rehabilitation Sciences, University of Birmingham, Birmingham, UKResearch Institute for Sport and Exercise Sciences, Liverpool John Moores University, Liverpool, UKSchool of Sport, Exercise and Rehabilitation Sciences, University of Birmingham, Birmingham, UK1 School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham, Birmingham, UKSchool of Sport, Exercise and Rehabilitation Sciences, University of Birmingham, Birmingham, UKSchool of Sport, Exercise and Rehabilitation Sciences, University of Birmingham, Birmingham, UKIntroduction SLE is a chronic autoimmune disease that results in sustained hyperactivation of innate and adaptive immune cells and widespread inflammatory damage. Regular exercise reduces SLE symptoms including fatigue and joint pain and improves patient quality of life. However, most individuals with SLE are not sufficiently active to achieve these benefits, and guidance on the optimal approach to exercise is limited. EXCEL will examine the feasibility of conducting a large-scale randomised controlled trial comparing the effects of a remotely monitored, home-based, exercise programme with standard of care for individuals with SLE.Methods and analysis 30 females with SLE will be recruited, and those randomised into Exercise (SLE-Ex) will codesign a progressive training plan with support from the research team. The aim of each 12-week plan will be to complete 150 min of moderate (60–70% heart rate max, HRmax) or 90 min of vigorous exercise (>70% HRmax) per week. SLE-Ex will be encouraged to exercise independently (without support) from weeks 13–18. Participants with SLE that are randomised into Control (SLE-Con) will maintain habitual activity without support for 18 weeks. Measures of feasibility and acceptability will be reported, and peripheral blood will be collected at weeks 0, 12 and 18 to explore whether the frequency, phenotype and metabolic profile of lymphocyte subsets has changed. Biomarkers of SLE activity, and self-reported measures of fatigue, sleep quality and health-related quality of life will also be monitored at these timepoints. Blood and self-reported measures will be compared with a healthy control (HC) group (n=15, age and body mass index matched) at baseline only.Ethics and dissemination A favourable ethical opinion was given by South East Scotland Research Ethics Committee (22/SS/0082). Findings will be disseminated at conferences and published in peer-reviewed journals.Trial registration number ISRCTN72757645.https://lupus.bmj.com/content/12/1/e001382.full |
| spellingShingle | John Reynolds Katie Hesketh Matthew Cocks Megan Quickfall Alex J Wadley Scott Green Jet Veldhuijzen Van Zanten EXamining the feasibility of exerCisE to manage symptoms of Lupus (EXCEL): a protocol for a randomised controlled pilot study Lupus Science and Medicine |
| title | EXamining the feasibility of exerCisE to manage symptoms of Lupus (EXCEL): a protocol for a randomised controlled pilot study |
| title_full | EXamining the feasibility of exerCisE to manage symptoms of Lupus (EXCEL): a protocol for a randomised controlled pilot study |
| title_fullStr | EXamining the feasibility of exerCisE to manage symptoms of Lupus (EXCEL): a protocol for a randomised controlled pilot study |
| title_full_unstemmed | EXamining the feasibility of exerCisE to manage symptoms of Lupus (EXCEL): a protocol for a randomised controlled pilot study |
| title_short | EXamining the feasibility of exerCisE to manage symptoms of Lupus (EXCEL): a protocol for a randomised controlled pilot study |
| title_sort | examining the feasibility of exercise to manage symptoms of lupus excel a protocol for a randomised controlled pilot study |
| url | https://lupus.bmj.com/content/12/1/e001382.full |
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