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Supervised exercise training as an adjunctive therapy for venous leg ulcers: study protocol for a randomised

Garry A Tew1, Jonathan Michaels2, Helen Crank3

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This feasibility study explores supervised exercise as a complementary treatment for venous leg ulcers. Findings will inform a larger trial on exercise

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Area of Science:

  • Vascular Medicine
  • Exercise Physiology
  • Wound Care

Background:

  • Venous leg ulcers are prevalent, chronic wounds significantly impacting patient quality of life.
  • Compression therapy is standard care, but adjunctive treatments are needed to improve healing and well-being.
  • Supervised exercise training (SET) shows potential for enhancing calf muscle pump function and overall health in individuals with venous ulcers.

Purpose of the Study:

  • To assess the feasibility of conducting a randomized controlled trial (RCT) for a supervised exercise program in venous leg ulcer patients.
  • To evaluate the acceptability and potential benefits of supervised exercise as an adjunct to compression therapy.
  • To determine optimal outcome measures and inform the design of a future, adequately powered RCT.

Main Methods:

  • A randomized, controlled, assessor-blinded, two-centre feasibility trial involving 80 adults with venous leg ulcers receiving compression therapy.
  • Participants were randomized to usual care (compression only) or usual care plus a 12-week supervised exercise program (3x 60-minute sessions/week).
  • Primary outcomes included recruitment, retention, and adherence rates; secondary outcomes assessed ulcer healing, quality of life, microvascular function, and physical fitness.

Main Results:

  • Feasibility outcomes (recruitment, retention, adherence) will be analyzed to guide future trial design.
  • Secondary outcomes will provide preliminary data on the effects of supervised exercise on ulcer healing, quality of life, and physical function.
  • Qualitative data from participant interviews will explore the acceptability of the exercise intervention and study procedures.

Conclusions:

  • This feasibility study is crucial for refining the supervised exercise program and study design for venous leg ulcer patients.
  • Results will inform the selection of appropriate outcome measures and provide estimates for sample size calculations for a definitive RCT.
  • The findings will contribute to establishing exercise as a viable adjunctive therapy for improving outcomes in venous leg ulcer management.