L. Bearne1,2, B. Volkmer1, A. Douiri3, D. Farran3, G. Fisher1, M. Galea Holmes4, B. Modarai5, J. Peacock3,6, C. Sackley1,7, M. Sekhon1,2, J. Weinman8, J. Bieles1
1King's College London, Population Health Sciences, London, United Kingdom, 2St George's, University of London, Population Health Research Institute, London, United Kingdom, 3King's College London, Life Course and Population Sciences, London, United Kingdom, 4University College London, Department of Applied Health Research, London, United Kingdom, 5King’s College London, Academic Department of Vascular Surgery, London, United Kingdom, 6Dartmouth College, The Geisel School of Medicine at Dartmouth, New Hampshire, United States, 7Nottingham University, Faculty of Medicine and Health Sciences, Nottingham, United Kingdom, 8King’s College London, Institute of Pharmaceutical Sciences, London, United Kingdom
Background: Walking is recommended for adults with peripheral arterial disease (PAD). However, provision of supervised exercise programmes is variable and adherence to self-directed walking tends to be low. MOtivating Structured walking Activity for Intermittent Claudication (MOSAIC) was a physiotherapist delivered walking exercise behaviour change intervention that incorporated motivational interviewing and behaviour change principles to increase participants’ motivation to walk and improve walking capacity.
Purpose: This study investigated whether MOSAIC improved walking capacity compared to usual care in adults with PAD and intermittent claudication.
Methods: This multicentre randomised trial enrolled participants from six public hospitals in the United Kingdom between January 2018-March 2020. Inclusion criteria comprised: aged ≥50 years with established PAD and intermittent claudication. Exclusion criteria included: unstable disease; walking >90 minutes/week; contraindications to exercise or completed/offered any medically supervised exercise in previous/upcoming six-months.
Consenting participants were randomly assigned to receive either MOSAIC (two face-to-face and two telephone consultations delivered over three-months by trained physiotherapists) or usual care.
The primary outcome was 6-minute walk distance (6MWD metres, m) at three-months (clinically meaningful change≥8m). Secondary outcomes included pain-free walking time (PFWT, 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, VascuQoL-6, range 6-24). Self-reported outcomes were also collected at six-months.
Outcomes were evaluated on an intention-to-treat basis using multiple regression with baseline value and stratification factors as covariates.
Consenting participants were randomly assigned to receive either MOSAIC (two face-to-face and two telephone consultations delivered over three-months by trained physiotherapists) or usual care.
The primary outcome was 6-minute walk distance (6MWD metres, m) at three-months (clinically meaningful change≥8m). Secondary outcomes included pain-free walking time (PFWT, 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, VascuQoL-6, range 6-24). Self-reported outcomes were also collected at six-months.
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 race) were recruited (95 participants/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] 16.7m [4.2m to 29.2m]; P=.009). All secondary outcomes also indicated greater improvement for those receiving MOSAIC than usual care (adjusted mean differences [95% CI]: PFWT 30.3 seconds [5.4 to 55.3] P=.02; WELCH 10.2 [5.7 to 14.7] P<.001; SR-MWD 181.0m [60m to 302 m] P=.003; NEADL 2.8 [0.1 to 5.4] P=.04) except VAScuQoL-6 (0.6 [−0.2 to 1.4] P=.17).
At six months, there was a sustained improvement in WELCH in participants receiving MOSAIC compared to usual care (adjusted mean difference [95% CI]: 77.4 [2.5 to 12.3] P=.003) but not SR-MWD (104m [−56m to 264m] P=.20), NEADL −1.4 [−4.4 to 1.6],P=.37) or VascuQoL-6 (0.5 [−0.5 to 1.5] P=.33). Thirty-seven adverse events (25 MOSAIC, 12 usual care) were reported. No adverse events were judge to be related to the trial.
At six months, there was a sustained improvement in WELCH in participants receiving MOSAIC compared to usual care (adjusted mean difference [95% CI]: 77.4 [2.5 to 12.3] P=.003) but not SR-MWD (104m [−56m to 264m] P=.20), NEADL −1.4 [−4.4 to 1.6],P=.37) or VascuQoL-6 (0.5 [−0.5 to 1.5] P=.33). Thirty-seven adverse events (25 MOSAIC, 12 usual care) were reported. No adverse events were judge to be related to the trial.
Conclusions: Among adults with PAD and intermittent claudication MOSAIC improved walking distance at 3-months with a clinically meaningful effect compared with usual care. It also improve pain-free walking time, walking disability and activities of daily living but not quality of life.
Implications: MOSAIC is an effective, home-based, walking exercise behaviour change intervention for the management of peripheral arterial disease that could be integrated into physiotherapy practice to support walking exercise behaviour change, improve walking capacity and disability.
Funding acknowledgements: This study was supported by a grant from the Dunhill Medical Trust, United Kingdom (R477/0516)
Keywords:
Peripheral Arterial Disease
Behaviour change
Walking exercise
Peripheral Arterial Disease
Behaviour change
Walking exercise
Topics:
Disability & rehabilitation
Older people
Health promotion & wellbeing/healthy ageing/physical activity
Disability & rehabilitation
Older people
Health promotion & wellbeing/healthy ageing/physical activity
Did this work require ethics approval? Yes
Institution: National Research Ethics Committee London–Bloomsbury, United Kingdom
Committee: National Research Ethics Committee London–Bloomsbury, United Kingdom
Ethics number: 17/LO/0568
All authors, affiliations and abstracts have been published as submitted.
