Recruitment to clinical trials of exercise: challenges in the peripheral arterial disease population

Guidon, Marie; McGee, Hannah

doi:10.1016/j.physio.2012.12.010

Cited by 15 publications

(15 citation statements)

References 26 publications

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“…The target recruitment rate of 25% was achieved, enabling successful piloting of screening procedures. Participants were drawn from a limited cohort previously recruited to an observational study, and so the recruitment rate and timeframe should be adjusted when planning a full-scale trial, taking into account known challenges to recruiting people with intermittent claudication to exercise trials [34,35]. However, successful enrolment to the initial observational study [16] demonstrated that people with intermittent claudication could be identified from the vascular outpatient setting, and were interested, willing and available to participate in research exploring walking as treatment for their condition.…”

Section: Discussionmentioning

confidence: 99%

A randomized controlled feasibility trial of a home-based walking behavior–change intervention for people with intermittent claudication

Holmes

Weinman

Bearne

2019

Journal of Vascular Nursing

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L. M. (2019). A randomized controlled feasibility trial of a home-based walking behavior-change intervention for people with intermittent claudication. JOURNAL OF VASCULAR NURSING, 37(2), 135-143. https://doi. ABSTRACTWalking treatment is recommended for improving intermittent claudication (IC), a debilitating symptom of leg pain caused by peripheral arterial disease. However, centre-based exercise programmes offered in a community or hospital setting are often not implemented or adhered to. We developed a home-delivered behaviour-change intervention, Motivating Structured walking Activity in Intermittent Claudication (MOSAIC), to increase walking in people with IC. A feasibility randomised controlled trial with nested qualitative interviews involving a subsample of trial participants was conducted. Feasibility criteria evaluated a) participant recruitment and retention; b) suitability of proposed outcome measures; and c) acceptability and adherence to the intervention and trial. Participants (adults ≥18 years diagnosed with IC identified from vascular outpatient clinics) were randomised 1:1 to receive MOSAIC treatment (two 60-minute home-based sessions and two 20-minute booster telephone calls incorporating behaviour-change techniques) or an attentioncontrol comparison. Outcomes (baseline and 16-week follow-up) included: the 6-Minute Walk Distance (metres), pedometer-assessed daily walking activity (steps/day), health related quality of life, physical functioning, and beliefs about walking treatment, peripheral arterial disease, and selfregulatory processes. 24 Participants (mean age 66.8 ±9.4 years, 79% male) were included.Feasibility criteria achieved were: recruitment rate (25%), participant retention (92%), and adherence to assigned treatment or attention-control sessions (71%). Missing data rates were <10% for all outcomes except baseline daily walking activity (36%). The trial protocol and interventions were acceptable to participants and the clinician. In conclusion, the MOSAIC trial was feasible to conduct, with the exception of high missing pedometer data. The intervention is an acceptable approach to facilitate walking among people with IC.

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Section: Discussionmentioning

confidence: 99%

A randomized controlled feasibility trial of a home-based walking behavior–change intervention for people with intermittent claudication

Holmes

Weinman

Bearne

2019

Journal of Vascular Nursing

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“… 8 , 15 More recently, an evaluation of strategies for recruiting Latino PAD patients for an exercise intervention encountered similar difficulties. 16 Throughout our recruitment efforts, potential participants reported a variety of comorbidities that influenced their decision whether to participate. Patients expressed that diminished physical function due to CVD, diabetic neuropathy, emphysema, chronic obstructive pulmonary disease, and after-effects of strokes and related surgeries contributed to a disease burden that made the daily business of living difficult, including those patients who consented to participation.…”

Section: Discussionmentioning

confidence: 99%

Recruiting older patients with peripheral arterial disease: evaluating challenges and strategies

Brostow¹,

Hirsch²,

Kurzer³

2015

PPA

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Peripheral arterial disease (PAD) is a group of syndromes characterized by chronic and progressive atherosclerosis with a high burden of physical disability and cardiovascular morbidity and mortality. Recruiting patients for clinical research is therefore challenging. In this article, we describe and evaluate our methods for recruiting participants for a cross-sectional feasibility study of PAD, nutritional status, and body composition. We used convenience and purposive sampling approaches to identify potential participants. Between May 2012 and April 2013, 1,446 patients were identified, and 165 patients (11.4%) responded to recruitment requests. The final enrollment was 64 participants (64/1,446; 4.4%), and four subjects (6.3%) subsequently withdrew from the study. Recruiting PAD patients presents a variety of challenges, due largely to the burdens of living with coexistent illnesses, and patients’ reluctance or inability to travel for research. In this article, we delineate suggestions for improving the efficacy of recruitment methods in future PAD studies.

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“…16,17 However, patients with co-morbidities and ischemic walking pain are often unable or unwilling to participate in regular exercise. 18 …”

Section: Introductionmentioning

confidence: 99%

Functional electrical stimulation improves quality of life by reducing intermittent claudication

Embrey

Alon

Brandsma

et al. 2017

International Journal of Cardiology

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Objective To determine if Functional Electrical Stimulation (FES) would improve ischemic pain, walking distance, and quality of life of patients with intermittent claudication. Design Single blind, randomized block, two factorial design. Patients Patients diagnosed with Peripheral Artery Disease (PAD) and intermittent claudication (IC). Ankle Brachial Index ranged 0.4–0.9 on at least one leg. Patients were randomly assigned to experimental (FES+Walk, N=13) or control (WALK, N=14) groups. Intervention Experimental group patients received FES to the dorsiflexor and plantarflexor muscles while walking for one hour/day, six days/week for eight weeks. Control group patients received similar intervention without FES. A Follow-up period of both groups lasted eight weeks. Outcome Measures Outcome measures were taken at baseline (T0), after intervention (T1), and after follow-up (T2). Primary measures included Perceived Pain Intensity (PPI), Six Minute Walk (6MW), and Peripheral Arterial Disease Quality of Life (PADQOL). Secondary measures included Intermittent Claudication Questionnaire (ICQ) and Timed Up and Go (TUG). Results Group by time interactions in PPI were significant (P<.001) with differences of 27.9 points at T1 and 36.9 points at T2 favoring the FES+Walk group. Groups difference in Symptoms and Limitations in Physical Function of the PADQOL reached significance (T1=8.9, and T2=8.3 improvements; P=.007). ICQ was significant (T1=9.3 and T2=13.1 improvements; P=.003). Improvement in 6MW and TUG tests were similar between groups. Conclusions and Relevance Walking with FES markedly reduced ischemic pain and enhanced QOL compared to just walking. FES while walking may offer an effective treatment option for the elderly with PAD and Intermittent Claudication.

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Recruitment to clinical trials of exercise: challenges in the peripheral arterial disease population

Cited by 15 publications

References 26 publications

A randomized controlled feasibility trial of a home-based walking behavior–change intervention for people with intermittent claudication

A randomized controlled feasibility trial of a home-based walking behavior–change intervention for people with intermittent claudication

Recruiting older patients with peripheral arterial disease: evaluating challenges and strategies

Functional electrical stimulation improves quality of life by reducing intermittent claudication

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