Clinical trial NCT06827691: Heat Therapy and Peripheral Artery Disease
Official title: Heat Therapy for People with Peripheral Artery Disease: a Randomised Wait-List Controlled Feasibility Trial.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Peripheral Arterial Disease
Cardiovascular Health
Vascular Function
Intermittent Claudication
Peripheral Vascular Diseases
Keywords: heat therapy
cardiovascular health
endothelial function
heat intervention
Lead sponsor: Manchester Metropolitan University
Sponsor class: OTHER
Collaborators: name: British Heart Foundation
First posted: 2025-02-14
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised wait-list controlled feasibility trial
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Maximum Walking Distance
timeFrame: Baseline to 8 weeks to 16 weeks
measure: Pain Free Walking Distance
timeFrame: Baseline to 8 weeks to 16 weeks
measure: Time for Onset of Claudication
timeFrame: Baseline to 8 weeks to 16 weeks
Secondary outcomes:
measure: VascuQoL-6
timeFrame: Baseline to 8 weeks to 16 weeks
measure: SF-36
timeFrame: Baseline to 8 weeks to 16 weeks
measure: EQ-5D-5L
timeFrame: Baseline to 8 weeks to 16 weeks
measure: Markers of Inflammation
timeFrame: Baseline to 8 weeks to 16 weeks
measure: Markers of Vascular Remodelling
timeFrame: Baseline to 8 weeks to 16 weeks
measure: Tissue Oxygenation
timeFrame: Baseline to 8 weeks to 16 weeks
measure: Vascular Ultrasound Imaging
timeFrame: Baseline to 8 weeks to 16 weeks
measure: Flow-Mediated Dilation
timeFrame: Baseline to 8 weeks to 16 weeks
measure: Ankle-Brachial Pressure Index
timeFrame: Baseline to 8 weeks to 16 weeks
measure: Blood Pressure
timeFrame: Baseline to 8 weeks to 16 weeks
measure: Pulse Wave Velocity and Pulse Wave Analysis
timeFrame: Baseline to 8 weeks to 16 weeks
measure: Physical Activity Levels
timeFrame: 7 days prior trial, 7 days prior heat intervention, 7 days after heat intervention, 7 days post trial.
Other outcomes:
measure: Intervention feasibility assessed via recruitment rate
timeFrame: through study completion, an average of 1 year
measure: Intervention feasibility assessed via protocol adherence
timeFrame: through study completion, an average of 1 year
measure: Intervention acceptability via workshop interviews
timeFrame: through study completion, an average of 1 year
measure: Intervention feasibility via participant comfort
timeFrame: through study completion, an average of 1 year
Locations:
city: Manchester
country: United Kingdom
facility: Manchester Metropolitan University
Study officials:
References: