NCT03435835

Heat Therapy to Reduce Pain and Improve Walking Tolerance

Heat Therapy to Reduce Leg Pain and Improve Walking Tolerance in Patients With Symptomatic Peripheral Artery Disease

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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).

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 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.

Conditions

• Peripheral Arterial Disease

Interventions

Type	Name	Description
DEVICE	Control/Sham Treatment	Water at 33ºC was circulated through water-circulating trousers.
DEVICE	Heat Therapy (HT)	Water at 42-43ºC was circulated through the water-circulating trousers.

Timeline

• Start date: 2018-08-01
• Primary completion: 2019-08-14
• Completion: 2019-08-14
• First posted: 2018-02-19
• Last updated: 2022-08-30
• Results posted: 2022-08-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study