Peripheral Arterial DiseaseHHTNCT03763331
Home-based Leg Heat Therapy
A study testing Heat Therapy in people with Peripheral Arterial Disease, run by Indiana University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Heat Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jan 2019to 21 Jun 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Home-based Leg Heat Therapy for Patients With Symptomatic Peripheral Arterial Disease
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.
Read the 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
- Being tested
- Control/Sham Treatment, Heat Therapy
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control/Sham TreatmentDevice
Thermoneutral water will be circulated through water-circulating trousers to maintain skin temperature at baselines levels daily for 90 minutes for 8 weeks.
Heat TherapyDevice
Water at 110 degrees F will be circulated through water-circulating trousers daily for 90 minutes for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Sham treatment | Sham comparator | Participants were dressed in water-circulating trousers that are connected to a pump. Water at 91.4 degrees F was circulated through the pants for 90 minutes daily for 8 weeks.. Receives: Device: Control/Sham Treatment |
| Heat Therapy | Active comparator | Participants were dressed in water-circulating trousers that are connected to a pump. Water at 110 degrees F will be circulated through the pants for 90 minutes daily for 8 weeks. Receives: Device: Heat Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 6-min Walk Distance
Change in 6-min walk distance from baseline to the 8-week follow-up
Measured: 8 weeks
Secondary outcomes (5)
Change in Treadmill Peak Walking Time
Change in treadmill peak walking time from baseline to 8-week follow-up
Measured: 8 weeks
Change in Peak Calf Blood Flow
Change in peak calf blood flow during reactive hyperemia from baseline to the 8-week follow-up
Measured: 8 weeks
Change in Leg Cutaneous Vascular Conductance
Change in cutaneous vascular conductance from baseline to the 8-week follow-up
Measured: 8 weeks
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)
Measured: 8 weeks
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2018
- Study start14 Jan 2019
- Primary completion21 Jun 2021
- Study completion21 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients were randomized (blocked and stratified by sex) using assignments generated from PROC PLAN in SAS Version 9.4 by the study statistician into one of two groups: those receiving leg heat therapy or those receiving the sham treatment.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Roseguini, Bruno, PhD
- Responsible party
- Principal investigator, Raghu Motaganahalli, Indiana University
- Investigators
- R Motaganahalli, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03763331
- Sponsor's protocol ID
- 1801755556
- Acronym
- HHT
- Status last verified
- Feb 2023
- First submitted
- 23 Nov 2018
- Last updated
- 1 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-based Leg Heat Therapy for Patients With Symptomatic Peripheral Arterial Disease
- ClinicalTrials.gov ID
- NCT03763331
- Acronym / sponsor ID
- HHT / 1801755556
- Conditions
- Peripheral Arterial Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Roseguini, Bruno, PhD
- Study start
- 14 Jan 2019 (actual)
- Primary completion
- 21 Jun 2021 (actual)
- Study completion
- 21 Jun 2021 (actual)
- First posted
- 4 Dec 2018 (actual)
- Results
- Posted 1 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Patients were randomized (blocked and stratified by sex) using assignments generated from PROC PLAN in SAS Version 9.4 by the study statistician into one of two groups: those receiving leg heat therapy or those receiving the sham treatment.
| Arm | Type | Receives |
|---|---|---|
| Sham treatment | Sham comparator | Device: Control/Sham TreatmentParticipants were dressed in water-circulating trousers that are connected to a pump. Water at 91.4 degrees F was circulated through the pants for 90 minutes daily for 8 weeks.. |
| Heat Therapy | Active comparator | Device: Heat TherapyParticipants were dressed in water-circulating trousers that are connected to a pump. Water at 110 degrees F will be circulated through the pants for 90 minutes daily for 8 weeks. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control/Sham TreatmentThermoneutral water will be circulated through water-circulating trousers to maintain skin temperature at baselines levels daily for 90 minutes for 8 weeks. | Device | Sham treatment |
| Heat TherapyWater at 110 degrees F will be circulated through water-circulating trousers daily for 90 minutes for 8 weeks. | Device | Heat Therapy |
Primary outcome
Change in 6-min Walk Distance
Time frame: 8 weeks
Change in 6-min walk distance from baseline to the 8-week follow-up
5 secondary outcomes
Change in Treadmill Peak Walking Time
Time frame: 8 weeks
Change in Peak Calf Blood Flow
Time frame: 8 weeks
Change in Leg Cutaneous Vascular Conductance
Time frame: 8 weeks
Change in the Vascular Quality of Life Questionnaire-6 Score
Time frame: 8 weeks
Change in the Short Form 36 Physical Functioning Score
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
R Motaganahalli principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heat Therapy in people with Peripheral Arterial Disease, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 6-min Walk Distance (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2023.