Randomized Clinical Trial on the Effects of Home-based Five Plus Exercise Training
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 14
- 主要终点
- walking distance
研究概览
简要总结
The aim of the study is to evaluate whether walking capacity in patients with intermittent claudication is improved more by home-based 5+ exercise training than by current recommendations of daily walking.
详细描述
Patients with intermittent claudication will by a web-based program be randomized to either "five plus training" or walking at least 30 minutes three times per week. During the "five plus training" the participants are standing in front of a wall, which is used for support of the balance. The body is lifted with the calf musculature to the maximal height that the subject can achieve. This is repeated until pain is felt in the calf musculature. Following the initiation of pain the subject performs five extra repetitions. The five extra calf raises are included to secure induction of ischemia followed by reperfusion to secure maximal training effect.
The patients are followed by absolute walking distance on a treadmill, quality of life questionnaire, and Ankle-brachial index.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
The care provider instructs about the training version. Other people will evaluate the participants before and after the training period
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pain in the calves after 300 m, or less measured on a treadmill
- •Stable symptoms last 6 months or more
- •The pain must be gone within 5 minutes after the patients stop walking
- •Ankle-Brachial index at 0.7 or lower at rest
- •Using statins and antiplatelet drugs since at least 3 months
- •age> 18 years
- •Signed consent
排除标准
- •pain in the hips or elsewhere outside the calves while walking
- •Remaining pain more than 5 minutes after stopped walking.
- •Impossible to compress the arteries while measruing ABI or ABI lower than 0.4
- •Use of statins and antiplatelet drugs less than 3 months
- •symptoms less than 6 months
- •Diabetes measured with HbA1c being over 48 mmol/mol (6%)
- •Revascularisation the last 6 months
- •Pain in the calves after longer than 300 m measured on a treadmill
- •Reduced mobility in the ankles
- •Reduced physical ability to perform a test on a treadmill.
- •Age less than 18 years
- •General conditions that impairs the ability to take part in a training study including Obesity, KOLS, heart disease, arthrosis, inflammatory joint diseases .
- •No Signed consent
结局指标
主要结局
walking distance
时间窗: 12 weeks
Measured on a tread mill before and after the training period
Quality of life
时间窗: 12 weeks
Measured with a questionnaire (VASCUQOL-6) before and after the training period
次要结局
未报告次要终点