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A plantar flexion device exercise programme for patients with peripheral arterial disease: a randomised prospective feasibility study
Tebbutt N, Robinson L, Todhunter J, Jonker L
Physiotherapy 2011 Sep;97(3):244-249
clinical trial
4/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: No; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

OBJECTIVES: To determine if the use of a plantar flexion device (Step It pedal) in a newly developed exercise programme is of benefit to patients with peripheral arterial disease. DESIGN: Prospective feasibility trial with patients randomised to either standard care or the Step It exercise programme plus standard care. SETTING: Physiotherapy Department at Cumberland Infirmary, Carlisle, UK. PARTICIPANTS: Patients were identified from the vascular team's referral list. In total, 42 patients agreed to take part; 18 in the control group and 24 in the intervention group. INTERVENTIONS: Eligible participants were randomised and received either standard care or took part in a plantar flexion resistance exercise programme, involving the Step It pedal, for a period of 12 weeks. MAIN OUTCOME MEASURES: Maximum walking distance, claudication distance and ankle brachial pressure index. RESULTS: Eighty-three percent of patients completed the study. Improvements in median distance to claudication symptoms and maximum walking distance were observed in the intervention group but not in the control group. Nine out of 15 (60%) participants in the control group and 14 out of 20 (70%) participants in the intervention group improved their walking distance. Ankle brachial pressure index remained virtually unchanged in both groups. CONCLUSIONS: Due to the variability of patients' fitness in the sample, it cannot be concluded whether use of the Step It pedal has additional benefits to patients over standard care. However, the study completion rate implies that patients with peripheral arterial disease are receptive to undertaking exercise programmes.

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