Authors' objectives: People with intermittent claudication are significantly less active compared to their peers without intermittent claudication, worsening future health outcomes. Supervised exercise therapy is not commonly available, but behaviour change techniques in unsupervised interventions can improve physical activity. Specific behaviour change techniques, theoretical mechanisms and contextual features linked to effectiveness remain unclear. To conduct an integrative synthesis of: effectiveness of behaviour change technique-based interventions on daily physical activity and clinical-/patient-reported outcomes; behaviour change techniques and theoretical mechanisms within effective behaviour change technique-based interventions; feasibility and acceptability. Primary outcomes: short term ( 6 months) of daily physical activity. Secondary outcomes: clinical-/patient-reported outcomes. People with intermittent claudication (IC) are significantly less active, by 40–45% compared to their peers without the condition. Supervised exercise therapy (SET) is recommended as the primary treatment, but access and adherence are low; traditional SET programmes are short-lived and do not improve daily activity levels. Incorporating behaviour change components boosts exercise intervention effectiveness, aiding in physical activity (PA) maintenance. However, the specific behaviour change techniques (BCTs), theoretical mechanisms and contextual features linked to effectiveness in individuals with IC remain unclear. To integrate the quantitative and qualitative evidence base for increasing and maintaining PA in IC by behaviour change interventions, researching concurrently to systematically review evidence about: (1) The effectiveness of behaviour change interventions in increasing and maintaining PA in people with IC; (2) the relationship between BCTs, intervention mechanisms and contextual factors in promoting PA in people with IC; (3) the feasibility and acceptance of behaviour change interventions for PA improvement in people with IC; and (4) the feasibility of delivering PA improvement services through behaviour change interventions for individuals with IC. Primary outcome measures were short-term (

Authors' results and conclusions: Fifty-three articles (41 studies) were included in systematic review 1, and 28 articles (28 studies) in systematic review 2. Eleven randomised controlled trials demonstrated that behaviour change technique-based interventions increased daily physical activity in the short term [increase of 0.20 standardised mean difference (95% confidence interval 0.07 to 0.33), ~ 473 steps/day] with high certainty. Evidence of maintenance of daily physical activity is unclear (increase of 0.12 standardised mean difference; ~ 288 steps/day). Behaviour change techniques aimed at improving patients’ intentions to engage in physical activity were most effective. Network analysis suggests that behaviour change technique-based interventions improved daily physical activity and may be better than supervised exercise therapy in maintaining daily physical activity. behaviour change technique-based interventions were acceptable and had short-medium-term benefits to initial/absolute claudication distance/time, walking impairment scores and disease-specific quality of life. The behaviour change technique-based interventions are effective, targeting intention to engage in physical activity, in improving daily physical activity and functional outcomes in the short term, although evidence is limited for maintenance. There is a need for more randomised controlled trials examining daily physical activity and clinical outcomes, including longer-term follow-up, with detailed descriptions of behaviour change techniques, costs and provider views. In total, 53 articles from 41 unique studies, published over a 41-year period, were included. Overall, RCTs included in this review (n = 11, 15 comparisons, 952 participants) demonstrated that BCT-based interventions increased daily PA in the short term (

Authors' methods: Seven primary studies databases; Cochrane Database of Systematic Reviews, the Database of Abstracts of Reviews of Effects, Health Technology Assessment Database and Trial Registers to 31 August 2023. Systematic review 1: interventions incorporating ≥ 1 behaviour change technique (coded using Behaviour Change Technique Taxonomy version 1, and Theoretical Domains Framework). Systematic review 2: quantitative, qualitative, mixed-methods research on patient/provider experiences. Study quality assessed using revised Cochrane risk-of-bias tool for randomised trials; Risk Of Bias In Non-randomised Studies – of Interventions and Mixed Methods Appraisal Tool. MEDLINE, EMBASE, Cumulative Index to Nursing and Allied Health Literature (EBSCO), Physiotherapy Evidence Database, Web of Science, PsycInfo® (American Psychological Association, Washington, DC, USA), Social Science Citation Index for primary studies. We also searched the Cochrane Database of Systematic Reviews, the Database of Abstracts of Reviews of Effects, the Health Technology Assessment Database, Trial Registers (International Standard Randomised Controlled Trial Number, EU Clinical Trial Register, https://clinicaltrials.gov/). Databases were searched from inception to 30 November 2022; plus, we reviewed weekly e-mail alerts of new literature until 31 August 2023. We also searched reference lists of included articles. Study selection Systematic review 1 – included randomised (RCT) and non-randomised controlled studies of adults diagnosed with IC, which assess an intervention incorporating at least one BCT. Systematic review 2 – included studies reporting on feasibility and acceptability of intervention to improve PA in people with IC, including quantitative, qualitative and mixed-methods research on patient/provider experiences with interventions. The limited number of primary studies hindered our ability to analyse the influence of contextual factors on intervention effectiveness. Included studies displayed significant methodological differences, although we managed to combine them for a meta-analysis. The control/comparison groups in the included studies also used BCTs, so our results reflect the intervention’s effects beyond those of the BCTs in the control/comparison groups. Furthermore, the lack of detailed intervention manuals and study protocols limited our assessment of the content and delivery, including BCTs and TDF domains. Many studies did not report recruitment rates or reasons for not taking part, reasons for dropout, adherence rate or reasons for non-adherence. Although some costs were presented, no studies considered the cost of implementation. We are not able to identify evidence about the feasibility and acceptability from the viewpoint of health professionals.

Project Status: Completed

URL for project: https://www.journalslibrary.nihr.ac.uk/programmes/hta/NIHR130664

Year Published: 2025

URL for published report: https://www.journalslibrary.nihr.ac.uk/hta/ZBNG5240

URL for additional information: English

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: England, United Kingdom

DOI: 10.3310/ZBNG5240

Organisation Name: NIHR Health Technology Assessment programme

Contact Address: NIHR Journals Library, National Institute for Health and Care Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK

Contact Name: journals.library@nihr.ac.uk

Contact Email: journals.library@nihr.ac.uk