Peripheral Arterial DiseaseNCT06827691
Heat Therapy and Peripheral Artery Disease
A study testing Heat Therapy Intervention in people with Peripheral Arterial Disease and Cardiovascular Health, run by Manchester Metropolitan University at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease, Cardiovascular Health, Vascular Function
- What is being tested?
- Heat Therapy Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 May 2025to 1 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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
Who cannot join
- • 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
Manchester Metropolitan University
Manchester
Amy Harwood, PhD, 07546370405, a.harwood@mmu.ac.uk
William Carey, MSc, 07753258893, 22502706@stu.mmu.ac.uk
About this study
Official title: 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.
Read the 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.
- Conditions
- Peripheral Arterial Disease, Cardiovascular Health, Vascular Function, Intermittent Claudication, Peripheral Vascular Diseases
- Being tested
- Heat Therapy Intervention
- Keywords
- heat therapy, cardiovascular health, endothelial function, heat intervention
- Medical subject headings
- Peripheral Arterial Disease, Intermittent Claudication, Peripheral Vascular Diseases, Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heat Therapy InterventionOther
Heat Therapy Intervention of shoulder depth submersion in a 40°C hot tub.
| Study group | Role | What they receive |
|---|---|---|
| Wait-list control | No intervention | Usual care 8 weeks |
| Heat Therapy Intervention | Active comparator | Heat therapy intervention through water submersion in a hot tub at ~40°C. Receives: Other: Heat Therapy Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Walking Distance
Maximal walking distance a participant can walk, through a graded treadmill test.
Measured: Baseline to 8 weeks to 16 weeks
Pain Free Walking Distance
Maximum distance participant can walk without pain (IC)
Measured: Baseline to 8 weeks to 16 weeks
Time for Onset of Claudication
Amount of time able to walk pain free before reaching claudication
Measured: Baseline to 8 weeks to 16 weeks
Secondary outcomes (12)
VascuQoL-6
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).
Measured: Baseline to 8 weeks to 16 weeks
SF-36
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.
Measured: Baseline to 8 weeks to 16 weeks
EQ-5D-5L
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).
Measured: Baseline to 8 weeks to 16 weeks
Markers of Inflammation
Investigators will compare blood sample measures of TNF-α, CRP, MCP-1, IL-1Ra, IL-4, IL-6, IL-8, IL-10, and eHSP70.
Measured: Baseline to 8 weeks to 16 weeks
Markers of Vascular Remodelling
Investigators will compare blood sample measures of HIF-1α, VEGF, endothelin-1, MMP-9, MMP-10 and nitrite.
Measured: Baseline to 8 weeks to 16 weeks
Tissue Oxygenation
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.
Measured: Baseline to 8 weeks to 16 weeks
Vascular Ultrasound Imaging
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.
Measured: Baseline to 8 weeks to 16 weeks
Flow-Mediated Dilation
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.
Measured: Baseline to 8 weeks to 16 weeks
Ankle-Brachial Pressure Index
Ankle brachial pressure index (ABPI): ABPI will be determined at rest and following a treadmill test by using standardised methodologies
Measured: Baseline to 8 weeks to 16 weeks
Blood Pressure
Following a 10-minute period of supine rest in a quiet room, blood pressure will be measured (in duplicate) using an automated sphygmomanometer.
Measured: Baseline to 8 weeks to 16 weeks
Pulse Wave Velocity and Pulse Wave Analysis
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.
Measured: Baseline to 8 weeks to 16 weeks
Physical Activity Levels
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).
Measured: 7 days prior trial, 7 days prior heat intervention, 7 days after heat intervention, 7 days post trial.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start1 May 2025 (estimated)
- Primary completion20 Nov 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised wait-list controlled feasibility trial
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Manchester Metropolitan University
- Sponsor type
- University, hospital or other
- Collaborators
- British Heart Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06827691
- Sponsor's protocol ID
- EthOS: 71125
- Status last verified
- Feb 2025
- First submitted
- 4 Feb 2025
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heat Therapy for People with Peripheral Artery Disease: a Randomised Wait-List Controlled Feasibility Trial.
- ClinicalTrials.gov ID
- NCT06827691
- Acronym / sponsor ID
- EthOS: 71125
- Conditions
- Peripheral Arterial Disease, Cardiovascular Health, Vascular Function, Intermittent Claudication, Peripheral Vascular Diseases
- Keywords
- heat therapy, cardiovascular health, endothelial function, heat intervention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Manchester Metropolitan UniversityUniversity, hospital or other
- Collaborators
- British Heart Foundation
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 20 Nov 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 14 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised wait-list controlled feasibility trial
| Arm | Type | Receives |
|---|---|---|
| Wait-list control | No intervention | –Usual care 8 weeks |
| Heat Therapy Intervention | Active comparator | Other: Heat Therapy InterventionHeat therapy intervention through water submersion in a hot tub at ~40°C. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- • Aged > 18 years
Key exclusion criteria (7 listed)
- • Walking impairment for a reason other than PAD
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 |
|---|---|---|
| Heat Therapy InterventionHeat Therapy Intervention of shoulder depth submersion in a 40°C hot tub. | Other | Heat Therapy Intervention |
Primary outcome
Maximum Walking Distance
Time frame: Baseline to 8 weeks to 16 weeks
Maximal walking distance a participant can walk, through a graded treadmill test.
Pain Free Walking Distance
Time frame: Baseline to 8 weeks to 16 weeks
Maximum distance participant can walk without pain (IC)
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
12 secondary outcomes
VascuQoL-6
Time frame: Baseline to 8 weeks to 16 weeks
SF-36
Time frame: Baseline to 8 weeks to 16 weeks
EQ-5D-5L
Time frame: Baseline to 8 weeks to 16 weeks
Markers of Inflammation
Time frame: Baseline to 8 weeks to 16 weeks
Markers of Vascular Remodelling
Time frame: Baseline to 8 weeks to 16 weeks
Tissue Oxygenation
Time frame: Baseline to 8 weeks to 16 weeks
Vascular Ultrasound Imaging
Time frame: Baseline to 8 weeks to 16 weeks
Flow-Mediated Dilation
Time frame: Baseline to 8 weeks to 16 weeks
Ankle-Brachial Pressure Index
Time frame: Baseline to 8 weeks to 16 weeks
Blood Pressure
Time frame: Baseline to 8 weeks to 16 weeks
Pulse Wave Velocity and Pulse Wave Analysis
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2025.
- Individual participant dataSharing planned: No
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Peripheral Arterial Disease
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.
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 Intervention in people with Peripheral Arterial Disease and Cardiovascular Health, run by Manchester Metropolitan University at 1 site in United Kingdom.
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 8 inclusion and 7 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: opening soon, as of the sponsor's last update on 14 Feb 2025. 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 Kingdom. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Walking Distance (time frame: Baseline to 8 weeks to 16 weeks). The study lists 3 primary outcomes in all. 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 14 Feb 2025.