Leg heat therapy to improve functional performance in peripheral artery disease
R
Raghu Motaganahalli, MD
Primary Investigator
Enrolling By Invitation
60-90 years
All
Phase
N/A
116 participants needed
2 Locations
Overview
Why is this study being done?
The purpose of this study is to investigate whether daily treatment with heat therapy for 12 weeks improves the circulation (blood flow) to the legs and improves walking ability in patients with peripheral artery disease.
THIS STUDY IS ENROLLING BY INVITATION ONLY - Patients of the peripheral vascular disease clinic at the Department of Vascular Surgery at Indiana University’s Methodist Hospital, the Non‐Invasive Vascular Laboratory at Methodist Hospital, or potentially eligible patients with peripheral artery disease. will be contacted directly by the research team about study participation.
Description
What will happen during the study?
- Participation involves attending in-person study visits at IU Methodist Professional Center Suite D3100 ‐ Vascular Lab in Indianapolis, IN. Participants will initially be asked to come to the laboratory on three different occasions to complete baseline testing.
- Before the treatment, at the end of the of treatment (12 weeks ± 7 days), and three months after the end of the treatment (12 weeks ± 7 days) you will have a series of exams, including: measurement of calf size and energy consumption using magnetic resonance imaging (MRI is a procedure in which radio waves and a powerful magnet linked to a computer are used to create detailed pictures of areas inside the body), and a series of walk, balance and strength tests.
- If a participant cannot have MRI done for any reason, that person can still take part in this study and will simply skip the MRI procedure.
- Participants will be randomly assigned, like the flip of a coin, to either the high heat therapy group or the low heat therapy group.
- Each participant will be given a leg heat therapy system (a pair of water‐circulating trousers and a portable pump) that will be mailed directly to the participant's home.
- Participants will be ask to apply the therapy every day for 90 min for 12 weeks in a row.
- Approximately 12 weeks after the end of the intervention (week 24 ± 7 days), participants will be asked to return for visit 6.
- The total duration of the study participation is 24 weeks.
Incentive/compensation
- Participants will be compensated up to $500 via debit card for completing all of the study requirements.
Additional information
The study is being conducted by Dr. Raghu Motaganahalli, Division of Vascular Surgery ‐ Indiana University School of Medicine and Dr. Bruno Roseguini, Department of Health and Kinesiology Purdue University. It is funded by the National Institute of Health, National Institute on Aging.
To learn more about Raghu Motaganahalli and his research interests, please visit this link: https://medicine.iu.edu/faculty/19930/motaganahalli-raghu
To learn more about Bruno Roseguini n and his research interests, please visit this link: https://hhs.purdue.edu/directory/bruno-roseguini/
Eligibility
You may be eligible for this study if you meet the following criteria:
-
Conditions:
peripheral artery disease, PAD
-
Age: Between 60 Years - 90 Years
-
Gender: All
Inclusion criteria:
- Diagnosis ofwer extremity peripheral artery disease
Exclusion criteria:
- Critical limb ischemia (ischemic rest pain or ischemia-related, non-healing wounds or tissue loss)
- Prior amputation
- Exercise tolerance limited by factors other than leg pain (e.g. angina, arthritis, severe lung disease, etc).
- Recent (<3 months) lower-extremity revascularization or orthopedic surgery
- Use of walking aid other than a cane
- Active cancer
- Chronic kidney disease (eGFR <30 by MDRD or Mayo or Cockcroft-Gault formula)
- Class 2 or 3 obesity (BMI ≥ 35 kg/m2)
- Unable to fit into water-circulating trousers
- A Mini-Mental Status Examination score <23
- Impaired thermal sensation in the leg
Updated on
01 Aug 2024.
Study ID: 13615
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