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.
• Aged > 18 years
ABPI < 0.9 at rest or a drop of 20mmHG after exercise testing
Diagnosed with IC
Able to walk unaided
• Walking impairment for a reason other than PAD
Critical limb ischaemia/rest pain
Asymptomatic PAD
Active cancer treatment
Parallel
Heat Therapy Intervention
Other interventionHeat Therapy Intervention of shoulder depth submersion in a 40°C hot tub.
Maximum Walking Distance
Maximal walking distance a participant can walk, through a graded treadmill test.
Pain Free Walking Distance
Maximum distance participant can walk without pain (IC)
Time for Onset of Claudication
Amount of time able to walk pain free before reaching claudication
VascuQoL-6
Quality of life was assessed using the Vascular Quality of Life Questionnaire (VacQoL), a disease-specific instrument comprised of 25 items rated on a 7-point Likert scale. When scored as a mean across items, the VacQoL has a range from 1 to 7, where 1 indicates the poorest quality of life and 7 the best. Alternatively, when summed, the total score ranges from 25 (worst) to 175 (best).
SF-36
The Short Form 36 Health Survey Questionnaire (SF-36) is used to indicate the health status of particular populations, to help with service planning and to measure the impact of clinical and social interventions.
EQ-5D-5L
The EQ-5D-5L is a brief, multi-attribute, generic, health status measure composed of 5 questions with Likert response options (descriptive system) and a visual analogue scale. The latter asks patients to rate their own health from 0 to 100 (the worst and best imaginable health, respectively).
Markers of Inflammation
Investigators will compare blood sample measures of TNF-α, CRP, MCP-1, IL-1Ra, IL-4, IL-6, IL-8, IL-10, and eHSP70.
Intervention feasibility assessed via recruitment rate
The investigators will record the number of eligible participants, as well as the number who enrol onto the study.
Intervention feasibility assessed via protocol adherence
The investigators will examine adherence on visits to the lab for the heat therapy intervention. I.e. How many sessions were completed throughout the 8 weeks.
Intervention acceptability via workshop interviews
Workshop interviews will be held between an investigator and participants who has either completed the intervention, withdrawn or declined participation, to ask questions regarding the intervention protocol.
Intervention feasibility via participant comfort
The investigators will examine participant thermal comfort/discomfort throughout each intervention day. This will be done through recording of time spent in tub and thermal comfort scales.
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Manchester Metropolitan University
Lead sponsor
British Heart Foundation
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
