Heat Therapy and Peripheral Artery Disease

NCT06827691 | Not Yet Recruiting DMC

• 1 other identifier: EthOS: 71125
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Arterial Disease; Cardiovascular Health; Vascular Function; Intermittent Claudication; Peripheral Vascular Diseases

Keywords

heat therapy; cardiovascular health; endothelial function; heat intervention

Outcome Measures

Primary Outcomes (3)

• Maximum Walking Distance

  Maximal walking distance a participant can walk, through a graded treadmill test.

  Baseline to 8 weeks to 16 weeks

• Pain Free Walking Distance

  Maximum distance participant can walk without pain (IC)

  Baseline to 8 weeks to 16 weeks

• Time for Onset of Claudication

  Amount of time able to walk pain free before reaching claudication

  Baseline to 8 weeks to 16 weeks

Secondary Outcomes (12)

• VascuQoL-6

  Baseline to 8 weeks to 16 weeks

• SF-36

  Baseline to 8 weeks to 16 weeks

• EQ-5D-5L

  Baseline to 8 weeks to 16 weeks

• Markers of Inflammation

  Baseline to 8 weeks to 16 weeks

• Markers of Vascular Remodelling

  Baseline to 8 weeks to 16 weeks

Other Outcomes (4)

• Intervention feasibility assessed via recruitment rate

  through study completion, an average of 1 year

• Intervention feasibility assessed via protocol adherence

  through study completion, an average of 1 year

• Intervention acceptability via workshop interviews

  through study completion, an average of 1 year

Study Arms (2)

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.

Other: Heat Therapy Intervention

Interventions

Heat Therapy Intervention OTHER

Heat Therapy Intervention of shoulder depth submersion in a 40°C hot tub.

Heat Therapy Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Manchester Metropolitan University: lead
• British Heart Foundation: collaborator

Study Sites (1)

Manchester Metropolitan University

Manchester, United Kingdom

Location

MeSH Terms

Conditions

Peripheral Arterial Disease; Intermittent Claudication; Peripheral Vascular Diseases; Hyperthermia

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Temperature Changes; Heat Stress Disorders; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised wait-list controlled feasibility trial

Study Record Dates

• First Submitted: February 4, 2025
• First Posted: February 14, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): November 20, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: February 14, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)