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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 ot stated（—）
- 性别
- All
入选标准
- •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.
排除标准
- •History of rheumatoid arthritis; exercise intervention contraindicated by unstable medical condition such as heart failure.