A physiotherapist-led, home-based walking intervention for peripheral arterial disease: MOtivating Structured walking Activity for Intermittent Claudication (MOSAIC) randomised controlled trial

ABSTRACT

Keywords Peripheral arterial disease;Exercise;Behaviour change Purpose: Walking is recommended for adults with peripheral arterial disease. However, provision of supervised walking programmes is variable and adherence to self-directed walking tends to be low. MOtivating Structured walking Activity for Intermittent Claudication (MOSAIC) is a physiotherapist-led, structured, home-based intervention that incorporates motivational interviewing and behaviour change principles to increase participants’ motivation and commitment to walking. This trial investigated whether MOSAIC improved walking performance compared to usual care in adults with peripheral arterial disease. Methods: This multicentre, parallel group, two-arm, randomised, controlled superiority trial enrolled participants from six NHS Trusts between January 2018 and March 2020. Inclusion criteria comprised aged ≥50 years with established peripheral arterial disease and intermittent claudication. Exclusion criteria included unstable disease;walking >90 min/week;contraindications to exercise or completed/offered any medically supervised exercise in previous/upcoming six-months. The primary outcome was six-minute walk distance (6MWD, metres (m)) at three-months (clinically meaningful change ≥8 m). Secondary outcomes included pain-free walking distance measured during six-minute walk test (PFWD, seconds), self-reported walking limitation (Walking Estimated-Limitation Calculated by History, WELCH, range 0–100;self-reported maximum walking distance, SR-MWD (m)), activities of daily living (Nottingham Extended Activities of Daily Living Questionnaire, NEADL, range 0–66), and quality of life (Vascular Quality of Life Questionnaire-6, VASuQoL-6, range 6–24). All measures were collected at baseline and three-months by an assessor masked to participant allocation. The self-reported outcomes were also collected at six-months. Consenting participants were randomly assigned (by King's Clinical Trials Unit remote computer-generated randomisation system) to receive either MOSAIC (two face-to-face and two telephone consultations delivered over three-months by trained physiotherapists, a pedometer and a bespoke manual) or usual care. Participants and physiotherapists were not masked to group allocation. Participant recruitment and collection of primary outcome data at three-months was ceased early due to COVID-19 restrictions. All self-reported six-month outcomes were collected as per protocol. Outcomes were evaluated on an intention-to-treat basis using multiple regression with baseline value and stratification factors as covariates. Results: 190 participants (mean age (Standard Deviation) 68 (9) years, 57 (30%) female, 150 (79%) White) were recruited (95/group). At three-months, participants receiving MOSAIC had greater mean 6MWD compared to participants receiving usual care (adjusted mean difference (95% confidence interval (95%CI) 16.4 m (3.8, 29.1)). Secondary outcomes also indicated greater improvement for those receiving MOSAIC than usual care (adjusted mean differences (95% CI) PFWD (31.2 s (6.3, 56.0));WELCH (10.2 points (5.6, 14.8));SR-MWD (251 s (11.0;194.9));NEADL (2.8 points (0.1;5.4));VASuQoL-6 (0.6 points (−0.2;1.4)). At six months, there was a sustained improvement in WELCH in participants receiving MOSAIC compared to usual care (adjusted mean difference (95% CI) 7.4 points (2.5, 1.3)). Results for the other secondary outcomes were inconclusive (SR-MWD (309.9 s (−17.8;637.6)), NEADL (−1.6 points (−4.6, 1.5)), VASuQoL-6 (0.6 points (−0.4;1.6)). Thirty-seven adverse events (25 MOSAIC, 12 usual care) were reported. Conclusion(s) MOSAIC is an effective treatment for the management of peripheral arterial disease and could be integrated into physiotherapy practice to support walking behaviour change. Impact MOSAIC is an effective treatment for the management of peripheral arterial disease and could be integrated into physiotherapy practice to support walking behaviour change. Funding acknowledgements This work was suppor ed by The Dunhill Medical Trust [grant number [R477/0516].