Abstract
Background: Walking is a recommended but underused treatment for intermittent claudication (IC) caused by peripheral arterial disease. Following feasibility evaluation, the efficacy of a novel physiotherapist-led intervention targeting walking in people with IC will be evaluated.
Methods: A phase II, multicentre, parallel, two-arm, single-blind, randomised controlled superiority trial will allocate (1:1, stratified by site) 192 people with IC to receive MOtivating Structured walking in Intermittent Claudication (MOSAIC) or usual NHS care. MOSAIC includes two 60-min individual face-to-face sessions and two 20-minute telephone boosters delivered over three months by a physiotherapist trained in motivational interviewing and behaviour-change techniques. The primary outcome is walking ability (6 Minute Walking Distance [6MWD]) 3 months post-randomisation. Secondary outcomes include, walking ability, activities of daily living, and quality of life (3 and 6-months). A qualitative sub-study (purposive sample of ~30 participants,10 physiotherapists) will explore in-depth experiences. A process evaluation of MOSAIC implementation, mechanisms, and unexpected pathways and consequences will be conducted.
Results: Intention-to-treat analysis using multiple regression (baseline 6MWD value, stratification factor and centre as covariates) will evaluate the primary outcome. Mean differences (95% Confidence Intervals) between groups will be reported. Other continuous outcomes will be evaluated similarly. Logistic regression will be used to analyse binary outcomes. Interviews with up to 30 participants and physiotherapists will be analysed thematically.
Discussion: MOSAIC is designed to support walking self-management in people with IC who frequently receive only simple walking advice, which is ineffective.
Conclusion: If efficacious, MOSAIC will enable people with IC to improve their mobility, daily activities, independence and quality of life.
Methods: A phase II, multicentre, parallel, two-arm, single-blind, randomised controlled superiority trial will allocate (1:1, stratified by site) 192 people with IC to receive MOtivating Structured walking in Intermittent Claudication (MOSAIC) or usual NHS care. MOSAIC includes two 60-min individual face-to-face sessions and two 20-minute telephone boosters delivered over three months by a physiotherapist trained in motivational interviewing and behaviour-change techniques. The primary outcome is walking ability (6 Minute Walking Distance [6MWD]) 3 months post-randomisation. Secondary outcomes include, walking ability, activities of daily living, and quality of life (3 and 6-months). A qualitative sub-study (purposive sample of ~30 participants,10 physiotherapists) will explore in-depth experiences. A process evaluation of MOSAIC implementation, mechanisms, and unexpected pathways and consequences will be conducted.
Results: Intention-to-treat analysis using multiple regression (baseline 6MWD value, stratification factor and centre as covariates) will evaluate the primary outcome. Mean differences (95% Confidence Intervals) between groups will be reported. Other continuous outcomes will be evaluated similarly. Logistic regression will be used to analyse binary outcomes. Interviews with up to 30 participants and physiotherapists will be analysed thematically.
Discussion: MOSAIC is designed to support walking self-management in people with IC who frequently receive only simple walking advice, which is ineffective.
Conclusion: If efficacious, MOSAIC will enable people with IC to improve their mobility, daily activities, independence and quality of life.
| Original language | English |
|---|---|
| Title of host publication | Clinical Rehabilitation |
| Publication status | Accepted/In press - 6 Feb 2018 |
| Event | The Society for Research in Rehabilitation Winter Meeting - Bristol, United Kingdom Duration: 6 Feb 2018 → 6 Feb 2018 Conference number: 40th |
Conference
| Conference | The Society for Research in Rehabilitation Winter Meeting |
|---|---|
| Abbreviated title | 40th SRR |
| Country/Territory | United Kingdom |
| City | Bristol |
| Period | 6/02/2018 → 6/02/2018 |