Supplementary information files for Management of fatigue with physical activity and behavioural change support in vasculitis: a feasibility study
datasetposted on 29.11.2021, 10:43 by Lorraine Harper, Catherine A. Hewitt, Ian Litchfield, Matthew D. Morgan, Dimitrios Chanouzas, Hollie K. Caulfield, Linda Coughlan, Caroline Dean, Kate Fletcher, Fiona Cramp, Sheila Greenfield, Natalie J. Ives, Sue Jowett, Shalela Kodabuckus, Sarah Tearne, Sukhwant Sehmi, Charlotte Edwardson, Nathan P. Dawkins, Amanda DaleyAmanda Daley
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.
Arthritis Research UK grant number 21199
University of Birmingham
NIHR Research Professorship award
- Sport, Exercise and Health Sciences