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].
ABSTRACT
BACKGROUND: Patients with hip fracture and depression are less likely to recover functional ability. This review sought to identify prognostic factors of depression or depressive symptoms up to 1 year after hip fracture surgery in adults. This review also sought to describe proposed underlying mechanisms for their association with depression or depressive symptoms. METHODS: We searched for published (MEDLINE, Embase, PsychInfo, CINAHL and Web of Science Core Collection) and unpublished (OpenGrey, Greynet, BASE, conference proceedings) studies. We did not impose any date, geographical, or language limitations. Screening (Covidence), extraction (Checklist for critical Appraisal and data extraction for systematic Reviews of prediction Modelling Studies, adapted for use with prognostic factors studies Checklist), and quality appraisal (Quality in Prognosis Studies tool) were completed in duplicate. Results were summarised narratively. RESULTS: In total, 37 prognostic factors were identified from 12 studies included in this review. The quality of the underlying evidence was poor, with all studies at high risk of bias in at least one domain. Most factors did not have a proposed mechanism for the association. Where factors were investigated by more than one study, the evidence was often conflicting. CONCLUSION: Due to conflicting and low quality of available evidence it is not possible to make clinical recommendations based on factors prognostic of depression or depressive symptoms after hip fracture. Further high-quality research investigating prognostic factors is warranted to inform future intervention and/or stratified approaches to care after hip fracture. TRIAL REGISTRATION: Prospero registration: CRD42019138690 .