CALIBRE-IC
Research type
Research Study
Full title
Exploring the feasibility of using home- and Blood Flow Restriction (BFR)- based exercise in combination with health coaching for the management of Peripheral Arterial Disease.
IRAS ID
359782
Contact name
Markos Klonizakis
Contact email
Sponsor organisation
Sheffield Health Partnership University NHSFT
Duration of Study in the UK
3 years, 5 months, 31 days
Research summary
PAD is a disease of the peripheral vascular system developing to arterial stenosis or occlusion of the lower legs. According to treatment guidelines, patient care should encompass advice and treatment aimed at secondary prevention of cardiovascular disease, with referral to a supervised exercise training(SET) programme. However, SET programmes are affected by low availability and
adherence.
Blood flow restriction exercise(BFR), where a tourniquet is used to reduce arterial inflow and occlude venous outflow, alongside resistance training, represents an innovative treatment approach for people with PAD(pPAD): our feasibility study, which delivered a supervised BFR programme demonstrated high adherence, excellent safety, as well as improvements in functional capacity, walking pain and QoL. However, as implementation of a community-based intervention would be difficult, we need to coproduce a bespoke, home-based, self-managed BFR-based intervention.
Aims Phase-1 (Co-Production): to produce a home-based intervention, modelled on our community-based, BFR exercise programme.
Phase-2 (Feasibility): a) to estimate the rates of recruitment, compliance, and retention for a definitive trial. b) To estimate outcome completion rate at follow-up visits. c) To refine a cost-effectiveness analysis framework.
Phase-3: To conduct post-intervention interviews with participants to refine the intervention's processes.
Methods/Timeline This is a 36-month study. Phase-1(8 months): we will conduct 3-4 focus groups and/or additional interviews with pPAD with stable claudication and
ankle&brachial index(ABI)⩽0.9(n=12) to co-produce the intervention. Once the intervention is developed, a workshop (n=6) will refine it.
Phase-2(24 months): Following baseline assessments(including anthropometrics, ABPI, clinical history&physical fitness), participants will be randomised into one-of-two groups: Group-A will follow the Phase-1-developed intervention (BFR-based
exercise&health advice) and standard therapy; Group-B will receive standard therapy only.
Although the intervention particulars will be defined in Phase-1, it will be self-managed, with regular personal contact with a facilitator. Assessments will be repeated at 3-and 6-months. We will then interview participants (Phase-3;intervention=8/control=4) to hear about their programme experience.REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
25/EM/0278
Date of REC Opinion
14 Jan 2026
REC opinion
Further Information Favourable Opinion