Management of fatigue with physical activity and behavioural change support in vasculitis: a feasibility study.
Author
Harper, LorraineHewitt, Catherine A
Litchfield, Ian
Morgan, Matthew D
Chanouzas, Dimitrios
Caulfield, Hollie K
Coughlan, Linda
Dean, Caroline
Fletcher, Kate
Cramp, Fiona
Greenfield, Sheila
Ives, Natalie J
Jowett, Sue
Kodabuckus, Shalela
Tearne, Sarah
Sehmi, Sukhwant
Edwardson, Charlotte
Dawkins, Nathan P
Daley, Amanda J
Publication date
2021-09-01
Metadata
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Objective: Patients with ANCA-associated vasculitis (AAV) experience high levels of fatigue, despite disease remission. This study assessed the feasibility and acceptability of a definitive randomized controlled trial of a behavioural-based physical activity intervention to support fatigue self-management in AAV patients. Methods: AAV patients in disease remission with fatigue (Multidimensional Fatigue Inventory-20 general fatigue domain ≥14) were randomly allocated to intervention or standard care in this single-centre open-label randomized controlled feasibility study. The intervention lasted 12 weeks and comprised eight face-to-face physical activity sessions with a facilitator and 12 weekly telephone calls. Participants were encouraged to monitor their physical activity using a tracker device (Fitbit). Standard care involved sign-posting to fatigue websites. The primary outcome was feasibility of a phase III trial assessed against three stop/go traffic light criteria, (recruitment, intervention adherence and study withdrawal). A qualitative study assessed participant views about the intervention. Results: A total of 248 patients were screened and 134 were eligible to participate (54%). Stop/go criteria were amber for recruitment; 43/134 (32%, 95% CI: 24, 40) eligible participants randomized, amber for adherence; 73% of participants attended all eight physical activity sessions, but only 11/22 (50%, 95% CI: 29, 71%) completed the intervention as per the intended schedule, and green for study withdrawal; 2/43 participants withdrew before 24 weeks (5%, 95% CI: 0, 11). Qualitative results suggested the intervention was acceptable. Conclusion: This study suggests a behavioural-based physical activity intervention targeting fatigue self-management was acceptable to patients with AAV, although recruitment and protocol adherence will need modification prior to a definitive trial. Clinical trial registration number: ISRCTN11929227.Citation
Harper L, Hewitt CA, Litchfield I, Morgan MD, Chanouzas D, Caulfield HK, Coughlan L, Dean C, Fletcher K, Cramp F, Greenfield S, Ives NJ, Jowett S, Kodabuckus S, Tearne S, Sehmi S, Edwardson C, Dawkins NP, Daley AJ. Management of fatigue with physical activity and behavioural change support in vasculitis: a feasibility study. Rheumatology (Oxford). 2021 Sep 1;60(9):4130-4140. doi: 10.1093/rheumatology/keaa890Type
ArticleAdditional Links
https://academic.oup.com/rheumatologyPMID
33369680Journal
RheumatologyPublisher
Oxford University Pressae974a485f413a2113503eed53cd6c53
10.1093/rheumatology/keaa890