Home-based Leg Heat Therapy for Patients With Symptomatic Peripheral Arterial Disease
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Peripheral Arterial Disease
- Sponsor
- Indiana University
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- Change in 6-min Walk Distance
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
The objective of this study is to evaluate the benefits of participating for 8 weeks in a home-based daily treatment with heat therapy (HT) or a thermoneutral control intervention, as assessed by vascular function, walking tolerance and quality of life.
Detailed Description
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 randomized, controlled study is to evaluate the benefits of participating for 8 weeks in a home-based daily treatment with heat therapy (HT) or a thermoneutral control intervention, as assessed by vascular function, walking tolerance and quality of life. 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. The duration (8 weeks) was chosen based on the recent report of Brunt and co-workers that the improvement in endothelial function promoted by repeat HT in sedentary individuals peaks at 8 weeks following the onset of treatment. Heat Therapy will be applied daily for 90 minutes using water-circulating 'pants' connected to a water pump. Outcomes will be assessed at the halfway point (end of week 4), at the completion of the intervention (end of week 8) and 4 weeks after the end of the intervention (week 12).
Investigators
Raghu Motaganahalli
Associate Professor
Indiana University
Eligibility Criteria
Inclusion Criteria
- •Men and women with a stable symptomatic PAD for ≥6 months
- •Ankle brachial index \<0.9 in at least one leg
- •Age between 40 and 80 years
Exclusion Criteria
- •Uncontrolled Diabetes (HbA1C \> 8.5 measured within 3 months prior to date of consent)
- •Wheelchair bound
- •Use of a walking aid (i.e. cane, crutches, walker, motorized chair)
- •Critical limb ischemia (ischemic rest pain or ischemia-related non healing wounds or tissue loss
- •Impaired thermal sensation in the legs
- •Exercise-limiting comorbidity
- •Chronic Heart Failure stages C and stage D (Stage C: structural heart disease is present and symptoms have occurred; Stage D: presence of advanced heart disease with continued heart failure symptoms requiring aggressive medical therapy)
- •Morbid obesity BMI \> 35 or unable to fit into water-circulating pants
- •Open wounds or ulcers on the extremity
- •Prior amputation
Outcomes
Primary Outcomes
Change in 6-min Walk Distance
Time Frame: 8 weeks
Change in 6-min walk distance from baseline to the 8-week follow-up
Secondary Outcomes
- Change in Peak Calf Blood Flow(8 weeks)
- Change in Leg Cutaneous Vascular Conductance(8 weeks)
- Change in Treadmill Peak Walking Time(8 weeks)
- Change in the Vascular Quality of Life Questionnaire-6 Score(8 weeks)
- Change in the Short Form 36 Physical Functioning Score(8 weeks)