Heat Therapy and Peripheral Artery Disease

Manchester Metropolitan University

Status

Not yet enrolling

Conditions

Peripheral Vascular Diseases

Cardiovascular Health

Intermittent Claudication

Vascular Function

Peripheral Arterial Disease

Treatments

Other: Heat Therapy Intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT06827691

EthOS: 71125

Details and patient eligibility

About

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.

Full 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.

Enrollment

70 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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