NCT03763331

Home-based Leg Heat Therapy

Home-based Leg Heat Therapy for Patients With Symptomatic Peripheral Arterial Disease

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Peripheral Arterial Disease

Interventions

Type	Name	Description
DEVICE	Control/Sham Treatment	Thermoneutral water will be circulated through water-circulating trousers to maintain skin temperature at baselines levels daily for 90 minutes for 8 weeks.
DEVICE	Heat Therapy	Water at 110 degrees F will be circulated through water-circulating trousers daily for 90 minutes for 8 weeks.

Timeline

• Start date: 2019-01-14
• Primary completion: 2021-06-21
• Completion: 2021-06-21
• First posted: 2018-12-04
• Last updated: 2023-03-01
• Results posted: 2023-03-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study