Title: Systematic review and integrated report on the quantitative and qualitative evidence base for behaviOur change interventions to promote Physical acTivity in people with InterMittent clAudication (OPTIMA)
Funder: Chief Scientist Office, Scotland

Abstract: A common problem among older adults affecting about 3.2 million people in the UK, is a chronic painful condition called “Background Peripheral Arterial Disease”. This happens when the arteries in the legs become clogged, leading to pain, cramps or fatigue when people walk, but going away when they rest. This is known as intermittent claudication. The knock on effect of this is that over time, people walk less often and/or for shorter distances till they end up spending most of their lives sitting, and this results in further long term health problems. People become less able to do everyday tasks and become more dependent on others. Among other things, it is important for everyone to walk at least 30 minutes a day to maintain their independence, reduce the chances of a heart attack or a stroke, and have a good quality of life. _x000D_ The purpose of this project is to examine conclusions made from other research teams who have looked into this condition where participants have become active and/or remained active for at least six months after their participation in a physical activity or exercise programme has ended. By drawing new conclusions from these studies, we will be able to help others improve their treatments and help patients remain mobile._x000D_ Our first aim is to understand what has to happen before people with intermittent claudication become active and remain committed to long term physical activity. Our second aim is to understand which parts of these programmes, and which other factors, had a hand in helping people increase their physical activity and/or make a long-term commitment to become more active. We also want to understand the feasibility and acceptability of these programmes for people with this condition and the people that provide them. In order to understand this, we will also examine wider issues relating to patients’ experience of this disease and physical activity._x000D_ We will consider the results of these previous studies by working with health professionals who care for people with this condition, and patients with this disease. Using ‘state of the art’ methods to combine results from many research papers to arrive at new information, we believe we can find a way forward to making a considerable difference to the care of patients with this condition, and by so doing will not only improve the quality of life for many, but will save the NHS money.

Lay abstract: Background: People with intermittent claudication (pwIC) are 40-45% less physically active than age matched controls, detrimentally affecting disease outcomes and all-cause mortality. Supervised exercise training (SET) is recommended as the primary therapy but access, uptake, and adherence is low and rarely lead to improved daily PA. Behaviour change (BC) interventions contribute to effectiveness of SET and support long-term PA. However, it is unclear which BC techniques (BCTs), theoretical mechanisms, or contextual features are linked to effectiveness. Understanding these is important to inform scalable interventions._x000D_ Aim: Synthesise the quantitative and qualitative evidence to inform BC strategies to support long-term change in PA in pwIC._x000D_ Research objectives: Researching concurrently to systematically review: (1) Effectiveness of interventions incorporating BC on PA; (2) Association between different BCTs, mechanisms of action, contextual features; (3) Acceptability, feasibility, appropriateness of BC interventions; (4) Feasibility of delivering services using interventions containing BC._x000D_ Design: Two systematic reviews (SRs): (1) SR1–randomised and non-randomised controlled trials of adults diagnosed with IC, which assess an intervention incorporating BCTs targeting PA improvement and report PA at baseline and at post intervention. (2) SR2-qualitative and mixed-methods research on patient/provider experiences. (3) Integrate effectiveness results with qualitative and mixed-method results. _x000D_ Search strategy: From inception until September 2021: Medline, Embase, Cinahl, Embase, PEDro, Web of Science, Psycinfo, NHS Economic Evaluation Database, Social Science Citation Index; Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effects, Health Technology Assessment Database, Trial Registers. Study authors will be contacted for additional details and reference lists of included articles will be scrutinized._x000D_ Research strategy: We have involved stakeholders in framing the review questions, planning the review, and will work with them in interpreting, disseminating, and translating the findings. SR1: Outcomes-changes-PA, walking capacity, cardiometabolic risk factors, disease outcomes, adverse events, quality of life, cost. Study quality-Cochrane ROB 2 and ROBINS-I. Code intervention and comparator components (BCT-v1 taxonomy), contextual futures (Template for Intervention Description and Replication classification), and mechanism of action (Theoretical Domains Framework). If appropriate, meta-analyses and (bivariate) mixed-effects meta-regression analyses to synthesise evidence. SR2: feasibility/acceptability of interventions from participants and providers. Coding and thematic analysis of qualitative and mixed-methods research. Study quality-conceptual clarity and interpretative rigour. SRs 1 and 2 integrated in mixed method synthesis approach._x000D_ Timelines: Setting-up & finalising review protocol (prefundingM1-2), studies search & screening (M1-4), data extraction & analysis (M5-14), reporting (M15-18). _x000D_ Expected outputs of research & dissemination: Findings will provide evidence-based strategies to support engagement with SETs, long-term maintenance of PA changes and best practice delivery for pwIC. Results will be disseminated to a range of stakeholders (clinicians, pwIC, support groups, commissioners). Policy, managerial and practice implications will be articulated using presentations, summaries, infographics and podcast. Final report will be produced for the NIHR and at least 2 research papers will be published.

Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL;8.1 ORGANISATION AND DELIVERY OF SERVICES
Health categories: CARDIOVASCULAR