Heat Therapy to Reduce Leg Pain and Improve Walking Tolerance in Patients With Symptomatic Peripheral Artery Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Peak Walking Time
研究概览
简要总结
The purpose of this study is to investigate whether exposure to heat therapy improves calf muscle oxygenation and enhances walking tolerance in patients with symptomatic Peripheral Arterial Disease (PAD).
详细描述
Heat therapy (HT) is an emerging non-invasive approach that has been shown to enhance vascular function of the leg in old individuals. The objective of this study is to establish evidence to support the validity of HT in improving walking tolerance on PAD patents.
Subjects will complete baseline assessments for eligibility, including medical history and ankle-brachial measurement. Eligible participants will be asked to report to the laboratory on 4 different occasions. The purpose of visits 1 and 2 The central hypothesis of this study, based on preliminary data, is that exposure to HT will enhance the oxygenation of calf muscles during exercise and as a result, the onset of pain will be delayed and walking performance will be enhanced. is to familiarize the participants with the treadmill walking test and assess the test-retest reliability of maximal walking time determination. On visits 3 and 4 participants will receive either heat treatment or a control treatment for 80 min prior to undergoing a symptom-limited incremental test on the treadmill.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Subjects will not be told outright which therapy there are receiving (thermoneutral or HT) and the Cardiologist supervising the exercise test will not be told which therapy was given.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women with stable symptomatic leg claudication for 6 months or longer.
- •Ankle brachial index < 0.9
排除标准
- •Heart Failure
- •Critical limb ischemia
- •Prior amputation
- •Exercise-limiting co-morbidity
- •Recent infrainguinal revascularization or planned during study period
- •Plans to change medical therapy during duration of the study
- •Active cancer
- •Chronic kidney disease
- •HIV positive, active HBV or HCV disease
- •Presence of any unsuitable comorbid clinical condition in the opinion of the PI
- •Peripheral neuropathy, numbness or paresthesia in the legs
- •Morbid obesity, BMI > 36 or unable to fit in water-circulating pants
- •Open wounds or ulcers on the extremity
- •Unable to walk on the treadmill
研究组 & 干预措施
Sham, then heat therapy
Participants were fitted with liquid-circulating trousers. In the sham-treatment session, water at 33℃ was circulated through the trousers for 90 min using a water pump (HTP-1500, Adroit Medical, Louden, Tennessee, United States). At least 72 hrs after completion of the sham treatment session, participants returned to the laboratory and received the heat therapy (HT) treatment. In the HT session, water at 43℃ was circulated through the tube-lined trousers using a heated bath circulator (HT; Aqua Relief Systems, Akron, Ohio, United States) with the goal of increasing leg skin temperature to 37-38ºC.
干预措施: Control/Sham Treatment (Device)
Sham, then heat therapy
Participants were fitted with liquid-circulating trousers. In the sham-treatment session, water at 33℃ was circulated through the trousers for 90 min using a water pump (HTP-1500, Adroit Medical, Louden, Tennessee, United States). At least 72 hrs after completion of the sham treatment session, participants returned to the laboratory and received the heat therapy (HT) treatment. In the HT session, water at 43℃ was circulated through the tube-lined trousers using a heated bath circulator (HT; Aqua Relief Systems, Akron, Ohio, United States) with the goal of increasing leg skin temperature to 37-38ºC.
干预措施: Heat Therapy (HT) (Device)
Heat therapy, then sham
Participants were fitted with liquid-circulating trousers. In the HT session, water at 43℃ was circulated through the tube-lined trousers using a heated bath circulator (HT; Aqua Relief Systems, Akron, Ohio, United States) with the goal of increasing leg skin temperature to 37-38ºC. At least 72 hrs after completion of the sham treatment session, participants returned to the laboratory and received the sham treatment. In the sham-treatment session, water at 33℃ was circulated through the trousers for 90 min using a water pump (HTP-1500, Adroit Medical, Louden, Tennessee, United States).
干预措施: Control/Sham Treatment (Device)
Heat therapy, then sham
Participants were fitted with liquid-circulating trousers. In the HT session, water at 43℃ was circulated through the tube-lined trousers using a heated bath circulator (HT; Aqua Relief Systems, Akron, Ohio, United States) with the goal of increasing leg skin temperature to 37-38ºC. At least 72 hrs after completion of the sham treatment session, participants returned to the laboratory and received the sham treatment. In the sham-treatment session, water at 33℃ was circulated through the trousers for 90 min using a water pump (HTP-1500, Adroit Medical, Louden, Tennessee, United States).
干预措施: Heat Therapy (HT) (Device)
结局指标
主要结局
Peak Walking Time
时间窗: Immediately after exposure to a single session of heat therapy or sham treatment, up to ~20 min
Exercise testing was performed in a motorized treadmill (Pro 27, Woodway, St. Paul, Minnesota, United States) following the Gardner-Skinner protocol, which consists of walking at a constant speed (2 mph) with a 2%-grade increase every 2 min (Gardner et al., 1991). Participants received standardized instructions and were asked to indicate when they first began to feel leg pain with a "thumbs up" signal (defined as COT), and then give a "thumbs down" signal when they could no longer continue with the test (defined as PWT).
次要结局
- Peak Diastolic Blood Pressure(The exercise test was performed immediately after exposure to a single session of either heat therapy or sham, up to ~20 min)
- Peak Calf Tissue Saturation Index(The exercise test was performed immediately after exposure to a single session of either heat therapy or sham, up to ~20 min)
- Peak Systolic Blood Pressure(The exercise test was performed immediately after exposure to a single session of either heat therapy or sham, up to ~20 min)
- Claudication Onset Time(The exercise test was performed immediately after exposure to a single session of either heat therapy or sham, up to ~20 min)
- Post-exercise Plasma Endothelin-1 Concentration(The exercise test was performed immediately after exposure to a single session of either heat therapy or sham, up to ~20 min. Ten minutes following completion of the incremental treadmill test, blood samples were obtained for the assessment of serum ET-1)
研究者
Raghu Motaganahalli
Associate Professor
Indiana University