Trials / Not Yet Recruiting
Not Yet RecruitingNCT06827691
Heat Therapy and Peripheral Artery Disease
Heat Therapy for People with Peripheral Artery Disease: a Randomised Wait-List Controlled Feasibility Trial.
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 70 (estimated)
- Sponsor
- Manchester Metropolitan University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Peripheral Arterial Disease
- Cardiovascular Health
- Vascular Function
- Intermittent Claudication
- Peripheral Vascular Diseases
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Heat Therapy Intervention | Heat Therapy Intervention of shoulder depth submersion in a 40°C hot tub. |
Timeline
- Start date
- 2025-05-01
- Primary completion
- 2027-11-20
- Completion
- 2028-01-01
- First posted
- 2025-02-14
- Last updated
- 2025-02-14
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT06827691. Inclusion in this directory is not an endorsement.