Heat Therapy and Peripheral Artery Disease

February 10, 2025 updated by: Manchester Metropolitan University

Heat Therapy for People with Peripheral Artery Disease: a Randomised Wait-List Controlled Feasibility Trial.

The purpose of the study is to assess the efficacy of a novel 8 week heat therapy intervention in intermittent claudication compared to usual care controls. Participants will be enrolled on a wait-list control randomised trial testing physiological, mechanistic, and health related outcome measures.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

70 participants with PAD will be randomised into one of two groups: either wait-list controls (usual care) or heat therapy intervention. The 8 week heat therapy intervention will consist of shoulder depth submersion in a hot tub at ~40°C for three times a week. Time for heating will be graded with aim of ~60 minutes submersion time by the end of the intervention. After 8 weeks the wait-list control group will then enrol onto the heat intervention and heat therapy participants will go back to usual care. The primary outcome measure for the study is improvement in maximum walking distance, pain free walking, and time to onset claudication. This will be measured via a graded exercise test. Secondary outcomes include Quality of life as measured by generic and vascular specific questionnaires (SF-36,VascuQoL and EQ-5D-5L), vascular health measured using ABPI, blood pressure, FMD, PWV, and markers of inflammation, oxidative stress, angiogenesis and vascular remodelling will be assessed from blood samples. All aforementioned outcome measures will be taken at baseline, 8 weeks, and 16 weeks. Physical activity behaviour (measured with an accelerometer) will be monitored 7 days prior to the beginning of the study, 7 days prior heat intervention, and 7 days after heat intervention.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • • Aged > 18 years

    • ABPI < 0.9 at rest or a drop of 20mmHG after exercise testing
    • Diagnosed with IC
    • Able to walk unaided
    • English-speaking and able to follow instructions
    • No previous history of heat syncope
    • Post-Menopausal or not on hormone therapy
    • Able to provide informed consent

Exclusion Criteria:

  • • Walking impairment for a reason other than PAD

    • Critical limb ischaemia/rest pain
    • Asymptomatic PAD
    • Active cancer treatment
    • Clinically diagnosed diabetes or those with peripheral neuropathy
    • Recent / frequent heat exposure (e.g., sauna or hot tubs).
    • severe aortic stenosis, unstable angina, recent MI, stroke or TIA

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Wait-list control
Usual care 8 weeks
Active Comparator: Heat Therapy Intervention
Heat therapy intervention through water submersion in a hot tub at ~40°C.
Other: Heat Therapy Intervention
Heat Therapy Intervention of shoulder depth submersion in a 40°C hot tub.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Maximum Walking Distance
Time Frame: Baseline to 8 weeks to 16 weeks
Maximal walking distance a participant can walk, through a graded treadmill test.
Baseline to 8 weeks to 16 weeks
Pain Free Walking Distance
Time Frame: Baseline to 8 weeks to 16 weeks
Maximum distance participant can walk without pain (IC)
Baseline to 8 weeks to 16 weeks
Time for Onset of Claudication
Time Frame: Baseline to 8 weeks to 16 weeks
Amount of time able to walk pain free before reaching claudication
Baseline to 8 weeks to 16 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
VascuQoL-6
Time Frame: Baseline to 8 weeks to 16 weeks
Quality of life was assessed using the Vascular Quality of Life Questionnaire (VacQoL), a disease-specific instrument comprised of 25 items rated on a 7-point Likert scale. When scored as a mean across items, the VacQoL has a range from 1 to 7, where 1 indicates the poorest quality of life and 7 the best. Alternatively, when summed, the total score ranges from 25 (worst) to 175 (best).
Baseline to 8 weeks to 16 weeks
SF-36
Time Frame: Baseline to 8 weeks to 16 weeks
The Short Form 36 Health Survey Questionnaire (SF-36) is used to indicate the health status of particular populations, to help with service planning and to measure the impact of clinical and social interventions.
Baseline to 8 weeks to 16 weeks
EQ-5D-5L
Time Frame: Baseline to 8 weeks to 16 weeks
The EQ-5D-5L is a brief, multi-attribute, generic, health status measure composed of 5 questions with Likert response options (descriptive system) and a visual analogue scale. The latter asks patients to rate their own health from 0 to 100 (the worst and best imaginable health, respectively).
Baseline to 8 weeks to 16 weeks
Markers of Inflammation
Time Frame: Baseline to 8 weeks to 16 weeks
Investigators will compare blood sample measures of TNF-α, CRP, MCP-1, IL-1Ra, IL-4, IL-6, IL-8, IL-10, and eHSP70.
Baseline to 8 weeks to 16 weeks
Markers of Vascular Remodelling
Time Frame: Baseline to 8 weeks to 16 weeks
Investigators will compare blood sample measures of HIF-1α, VEGF, endothelin-1, MMP-9, MMP-10 and nitrite.
Baseline to 8 weeks to 16 weeks
Tissue Oxygenation
Time Frame: Baseline to 8 weeks to 16 weeks
Superficial tissue oxygen saturation and muscle oxygen consumption will be measured throughout the protocol by a NIRS probe placed on the skin surface of the medial gastrocnemius on the most affected leg. Measurements will be recorded during the graded treadmill test.
Baseline to 8 weeks to 16 weeks
Vascular Ultrasound Imaging
Time Frame: Baseline to 8 weeks to 16 weeks
Vascular ultrasound images of the carotid, brachial and superficial femoral artery will be obtained using a high-resolution duplex machine (Terason, Burlington, MA) and subsequently used to calculate wall thickness, changes in arterial blood flow and shear stress.
Baseline to 8 weeks to 16 weeks
Flow-Mediated Dilation
Time Frame: Baseline to 8 weeks to 16 weeks
Flow-mediated dilation (FMD) of the brachial artery will be measured after 10 min of supine rest via reactive hyperemia in response to transient ischemia of the lower arm according to international guidelines.
Baseline to 8 weeks to 16 weeks
Ankle-Brachial Pressure Index
Time Frame: Baseline to 8 weeks to 16 weeks
Ankle brachial pressure index (ABPI): ABPI will be determined at rest and following a treadmill test by using standardised methodologies
Baseline to 8 weeks to 16 weeks
Blood Pressure
Time Frame: Baseline to 8 weeks to 16 weeks
Following a 10-minute period of supine rest in a quiet room, blood pressure will be measured (in duplicate) using an automated sphygmomanometer.
Baseline to 8 weeks to 16 weeks
Pulse Wave Velocity and Pulse Wave Analysis
Time Frame: Baseline to 8 weeks to 16 weeks
Pulse wave velocity will be measured using central (carotid-femoral) and peripheral (carotid-radial) via a handheld tonometer following standard guidelines. This will be used with a SphygmoCor XCEL.
Baseline to 8 weeks to 16 weeks
Physical Activity Levels
Time Frame: 7 days prior trial, 7 days prior heat intervention, 7 days after heat intervention, 7 days post trial.
Physical activity will be measured using a wrist-worn accelerometer. Physical activity will be monitored for 7 days at a time. This including 7 days pre-trial, 7 days pre heat intervention, 7 days post heat intervention, and 7 days post trial (Dependent on what group randomisation was first).
7 days prior trial, 7 days prior heat intervention, 7 days after heat intervention, 7 days post trial.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Intervention feasibility assessed via recruitment rate
Time Frame: through study completion, an average of 1 year
The investigators will record the number of eligible participants, as well as the number who enrol onto the study.
through study completion, an average of 1 year
Intervention feasibility assessed via protocol adherence
Time Frame: through study completion, an average of 1 year
The investigators will examine adherence on visits to the lab for the heat therapy intervention. I.e. How many sessions were completed throughout the 8 weeks.
through study completion, an average of 1 year
Intervention acceptability via workshop interviews
Time Frame: through study completion, an average of 1 year
Workshop interviews will be held between an investigator and participants who has either completed the intervention, withdrawn or declined participation, to ask questions regarding the intervention protocol.
through study completion, an average of 1 year
Intervention feasibility via participant comfort
Time Frame: through study completion, an average of 1 year
The investigators will examine participant thermal comfort/discomfort throughout each intervention day. This will be done through recording of time spent in tub and thermal comfort scales.
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Manchester Metropolitan University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
British Heart Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 20, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 4, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EthOS: 71125

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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