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A multi-centre, prospective, randomised controlled feasibility study of plantar resistance exercise therapy for venous leg ulcers -- results of the PREVUE study
Jonker L, Todhunter J, Schutter J, Halliday C, Fisher S
Phlebology 2020 May;35(4):237-246
clinical trial
7/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; 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 evaluate the feasibility of an interventional study involving a seated plantar resistance exercise programme, using a StepIt pedal, aimed at promotion of venous leg ulcer (VLU) healing. METHODS: Thirty-two VLU patients, recruited from community, GP and hospital settings, were randomised to either a standard care or adjuvant StepIt exercise programme arm for up to 12 weeks. The exercise involved a twice daily routine of ten times one-minute of exercise, ie, two-second push and two-second lift repetitions (equating to 300 daily steps). RESULTS: Complete healing of the VLU was observed in 10 out of 15 (67%; StepIt cohort) and 7 out of 17 (41%; control cohort) respectively (p-value 0.18, Fisher's exact test). Baseline differences between the two cohorts were longer wound chronicity, less VLU-related pain, and better VLU-related quality of life in the StepIt cohort. One adverse event, involving increased wound exudate and slough production, was observed in a participant using StepIt, and no study withdrawals were recorded in either arm. StepIt users whose wound had completely healed by week 12 were more likely to be compliant with the exercise programme (self-reported) and more positive about the trial experience; however, all would recommend the device to others. CONCLUSIONS: Seated plantar resistance exercise shows promise and may accelerate VLU wound healing. The StepIt pedal is well-received by patients, and its efficacy may depend on the degree of patient compliance with the exercise programme. Further larger scale studies are indicated to allow more concrete inferences to be made on the clinical and potential health economics impact that this device may have.

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