Home-based Leg Heat Therapy

Peripheral Arterial Disease Clinical Trial

— HHT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03763331
• Other study ID #: 1801755556
• Status: Completed
• Phase: N/A
• Start date: January 14, 2019
• Est. completion date: June 21, 2021

Study information

• Verified date: February 2023
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: June 21, 2021
• Est. primary completion date: June 21, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

• Lower extremity revascularization, major orthopedic surgery, cardiovascular event, or coronary revascularization in the previous three months

• Planned revascularization or major surgery during the next six months

• Plans to change medical therapy during the duration of the study

• Active treatment for cancer

• Chronic kidney disease (eGFR <30 by MDRD or Mayo or Cockcroft-Gault formula).

• HIV positive, active HBV or HCV disease.

• Presence of any clinical condition that makes the patient not suitable to participate in the trial.

• Unable to walk on the treadmill

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

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.
• Heat Therapy
Water at 110 degrees F will be circulated through water-circulating trousers daily for 90 minutes for 8 weeks.

Locations

Country	Name	City	State
United States	IU Heath Methodist	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	Roseguini, Bruno, PhD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in 6-min Walk Distance	Change in 6-min walk distance from baseline to the 8-week follow-up	8 weeks
Secondary	Change in Treadmill Peak Walking Time	Change in treadmill peak walking time from baseline to 8-week follow-up	8 weeks
Secondary	Change in Peak Calf Blood Flow	Change in peak calf blood flow during reactive hyperemia from baseline to the 8-week follow-up	8 weeks
Secondary	Change in Leg Cutaneous Vascular Conductance	Change in cutaneous vascular conductance from baseline to the 8-week follow-up	8 weeks
Secondary	Change in the Vascular Quality of Life Questionnaire-6 Score	Change in Vascular Quality of Life Questionnaire-6 score from baseline to the 8-week follow-up. The total VASCUQOL score is the average score of questions answered and ranges from 1 (worst QOL) to 7 (best QOL)	8 weeks
Secondary	Change in the Short Form 36 Physical Functioning Score	Change in the physical functioning subscale score from baseline to the 8-week follow-up. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved. A high score defines a more favorable health state.	8 weeks