A pilot randomised controlled trial of home-based progressive resistant exercises and usual care compared to usual care alone for patients with venous leg ulcers
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Venous leg ulceration
- Sponsor
- Principal investigator (Andrew Jull)
- Enrollment
- 40
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
The exercise programme consisted of three sets progressive repetitions (80% of the participant's maximum number, re-prescribed every three weeks) of two-legged heel raises every alternate day. All participants received compression with a system of their own or their nurse's choosing and any dressing could be used. The outcomes were change in calf muscle pump function, changes in ulcer area, number of participants with healed ulcers, time-to-complete healing, and adverse events. Participants were followed up for 12 weeks after randomisation. Forty participants were randomly assigned to an exercise programme or usual care (compression alone). Calf muscle pump changes favoured the exercise group, but the healing outcomes did not. The latter outcomes may have been influenced by an imbalance of large ulcers randomised to the exercise group. More adverse events were reported in the exercise group than the usual care group.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Community\-based diagnosis of venous ulceration based on case definition of clinical presentation, absence of other causative diseases and ankle\-brachial index greater than 0\.8; able to be treated with compression therapy; able to give informed consent; and able to perform at least one heel raise.mmunity\-based diagnosis of venous ulceration based on case definition of clinical presentation, absence of other causative diseases and ankle\-brachial index greater than 0\.8; able to be treated with compression therapy; able to give informed consent; and able to perform at least one heel raise.
Exclusion Criteria
- •History of rheumatoid arthritis; exercise intervention contraindicated by unstable medical condition such as heart failure.
Outcomes
Primary Outcomes
Not specified