Blood Flow Restricted Resistance Training in Peripheral Arterial Disease: a Randomised Controlled Trial Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Recruitment Rates
研究概览
简要总结
A randomised controlled trial evaluating the feasibility and acceptability of a 12 week lower body blood flow restricted resistance exercise programme for people with peripheral arterial disease.
详细描述
The primary aim of this study is to determine the feasibility of 12 weeks of lower body resistance exercise performed with blood flow restriction (BFR) in people with peripheral arterial disease.
Resistance exercise with BFR involves placing inflatable cuffs proximal to the exercise limbs in order to manipulate blood flow and enhance the training response.
Secondary aim of this study is to evaluate changes in ABPI, muscle size, strength and physical function at mid-and post- intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Men and women with PAD 6 months post diagnosis.
- •Ankle-brachial pressure index <0.
- •People physically able to perform leg press and leg extension resistance exercise.
排除标准
- •Ankle-brachial pressure index >0.
- •People unable to visit the laboratory twice weekly for exercise sessions.
- •People unable to do leg press and leg extension exercise.
- •People whose walking is limited by a non-PAD condition.
- •People with PAD with critical limb ischemia (including symptoms of pain at rest and skin ulcers).
- •People with Dementia.
- •People who have had major surgery or myocardial infarction within the past 6 months.
- •Previous stroke.
- •Previous thrombosis.
- •People who have major surgery scheduled during the intervention period.
研究组 & 干预措施
BFR
Participants will participate in a supervised low load lower body blood flow restriction resistance exercise program twice a week for 12 weeks
干预措施: Blood flow restricted resistance exercise (BFR) (Other)
NON-BFR
Participants will participate in a supervised low load lower resistance exercise program twice a week for 12 weeks (matched training volume as experimental arm but without BFR)
干预措施: Resistance exercise without blood flow restricted (NON-BFR) (Other)
结局指标
主要结局
Recruitment Rates
时间窗: 3 months
Defined as rate of invited participants who are eligible and consenting.
Retention Rates
时间窗: 3 months
Retention rates will be established as discontinuation with the exercise intervention and absence from the assessment sessions.
Acceptability of allocation
时间窗: 3 months
will be assessed by attrition rates, comparing participant withdrawal between experimental and control groups and reasons for dropout where appropriate.
Acceptability of the exercise study
时间窗: 3 months
Will be evaluated by participants feedback via one-to-one semi-structured interviews.
Completion Rates
时间窗: 3 months
Completion is determined by participants that attend baseline testing and post exercise intervention testing.
次要结局
- Change in PAD severity(3 months)
- Change in muscle size(3 months)
- Change in strength(3 months)
- Change in walk ability(3 months)
- Change in physical function(3 months)