Heat Therapy for People with Peripheral Artery Disease: a Randomised Wait-List Controlled Feasibility Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Maximum Walking Distance
研究概览
简要总结
The purpose of the study is to assess the efficacy of a novel 8 week heat therapy intervention in intermittent claudication compared to usual care controls. Participants will be enrolled on a wait-list control randomised trial testing physiological, mechanistic, and health related outcome measures.
详细描述
70 participants with PAD will be randomised into one of two groups: either wait-list controls (usual care) or heat therapy intervention. The 8 week heat therapy intervention will consist of shoulder depth submersion in a hot tub at ~40°C for three times a week. Time for heating will be graded with aim of ~60 minutes submersion time by the end of the intervention. After 8 weeks the wait-list control group will then enrol onto the heat intervention and heat therapy participants will go back to usual care. The primary outcome measure for the study is improvement in maximum walking distance, pain free walking, and time to onset claudication. This will be measured via a graded exercise test. Secondary outcomes include Quality of life as measured by generic and vascular specific questionnaires (SF-36,VascuQoL and EQ-5D-5L), vascular health measured using ABPI, blood pressure, FMD, PWV, and markers of inflammation, oxidative stress, angiogenesis and vascular remodelling will be assessed from blood samples. All aforementioned outcome measures will be taken at baseline, 8 weeks, and 16 weeks. Physical activity behaviour (measured with an accelerometer) will be monitored 7 days prior to the beginning of the study, 7 days prior heat intervention, and 7 days after heat 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
- •• Aged > 18 years
- •ABPI < 0.9 at rest or a drop of 20mmHG after exercise testing
- •Diagnosed with IC
- •Able to walk unaided
- •English-speaking and able to follow instructions
- •No previous history of heat syncope
- •Post-Menopausal or not on hormone therapy
- •Able to provide informed consent
排除标准
- •• Walking impairment for a reason other than PAD
- •Critical limb ischaemia/rest pain
- •Asymptomatic PAD
- •Active cancer treatment
- •Clinically diagnosed diabetes or those with peripheral neuropathy
- •Recent / frequent heat exposure (e.g., sauna or hot tubs).
- •severe aortic stenosis, unstable angina, recent MI, stroke or TIA
结局指标
主要结局
Maximum Walking Distance
时间窗: Baseline to 8 weeks to 16 weeks
Maximal walking distance a participant can walk, through a graded treadmill test.
Time for Onset of Claudication
时间窗: Baseline to 8 weeks to 16 weeks
Amount of time able to walk pain free before reaching claudication
Pain Free Walking Distance
时间窗: Baseline to 8 weeks to 16 weeks
Maximum distance participant can walk without pain (IC)
次要结局
- VascuQoL-6(Baseline to 8 weeks to 16 weeks)
- SF-36(Baseline to 8 weeks to 16 weeks)
- EQ-5D-5L(Baseline to 8 weeks to 16 weeks)
- Markers of Inflammation(Baseline to 8 weeks to 16 weeks)
- Markers of Vascular Remodelling(Baseline to 8 weeks to 16 weeks)
- Tissue Oxygenation(Baseline to 8 weeks to 16 weeks)
- Vascular Ultrasound Imaging(Baseline to 8 weeks to 16 weeks)
- Flow-Mediated Dilation(Baseline to 8 weeks to 16 weeks)
- Ankle-Brachial Pressure Index(Baseline to 8 weeks to 16 weeks)
- Blood Pressure(Baseline to 8 weeks to 16 weeks)
- Pulse Wave Velocity and Pulse Wave Analysis(Baseline to 8 weeks to 16 weeks)
- Physical Activity Levels(7 days prior trial, 7 days prior heat intervention, 7 days after heat intervention, 7 days post trial.)