Patient education interventions to improve physical activity in patients with intermittent claudication: a protocol for a systematic mixed-studies review

INTRODUCTION: Peripheral arterial disease (PAD) and intermittent claudication (IC) decrease an individual's capacity to engage in physical activity (PA) with potentially negative effects on PA behaviour. Strategies to improve PA among this population may provide a range of positive health benefits. We present a protocol to assess the components of patient education interventions that improve PA capacity and PA behaviour in patients with PAD and IC. METHODS AND ANALYSIS: Published peer-reviewed studies will be searched in the following databases: CINAHL, the Cochrane Library, OVID, ProQuest, AMED, MEDLINE, PsycINFO, Web of Science Core Collection and PEDro, to identify literature investigating the effect of patient education on PA of patients with PAD and IC, or studies that investigated patients' perceptions or experience with these interventions. Two authors will independently perform screening for study eligibility, result synthesis and then appraise study quality. For interventions without follow-up, primary outcome measures will include change in PA capacity, or change in free-living PA behaviour; where there was a follow-up postintervention, the primary outcome will be rate of adherence to PA behaviour improvement. A three-phase sequential explanatory synthesis of mixed studies will be employed to answer the research questions. Homogenous quantitative data will be analysed using a random-effects model of meta-analysis with results presented as relative risk for dichotomous outcomes and as weighted or standardised means for continuous outcomes. Qualitative data will be analysed using thematic synthesis. This review protocol is reported according to the Preferred Reporting Items for Systematic review and Meta-Analysis Protocols (PRISMA-P) 2015 guidelines. TRIAL REGISTRATION NUMBER: CRD42015027314.