Heat Therapy and Peripheral Artery Disease

Last updated: February 10, 2025
Sponsor: Manchester Metropolitan University
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Claudication

Peripheral Arterial Occlusive Disease

Intermittent Claudication

Treatment

Heat Therapy Intervention

Clinical Study ID

NCT06827691
EthOS: 71125
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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 Design

Total Participants: 70
Treatment Group(s): 1
Primary Treatment: Heat Therapy Intervention
Phase:
Study Start date:
May 01, 2025
Estimated Completion Date:
January 01, 2028

Study 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.

Connect with a study center

  • Manchester Metropolitan University

    Manchester,
    United Kingdom

    Site Not Available

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