Peripheral arterial disease Circulatory System
Conditions
Interventions
This is a three-phase study (comprising intervention design and feasibility), informed by the MRC complex interventions framework, using both qualitative (Phase 1: a participatory approach based on fo
Phase 3: qualitative study). Total study duration will be 36 months.
Phase 1 (intervention co-production):
We will gather the views and opinions of pPAD in 3-4 focus groups and/or additional intervie
the home-based exercise programme will be centred on published evidence about exercises and on our successful BFR community intervention.
Once this information is collected, we will work collaborative
60 minutes). Baseline measurements will be repeated at 3 months (visit 2) and 6 months (visit 3).
During follow-up visits, assessors will review participants’ paper resource use diary, as used success
Sponsors
Sheffield Health Partnership University NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Patients with PAD with stable claudication (i.e., symptomatic presentation unchanged for 6 months) 2. Ankle–brachial index (ABI) =0.9
Exclusion criteria
Exclusion criteria: 1. Stents in the artery system of the thigh; symptomatic presentation of rest pain, skin ulcers, or gangrene 2. Impaired walking by a non-PAD condition (e.g., hip or knee osteoarthritis) or cannot walk without a walking aid
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recruitment rates measured using rate of consenting participants over those invited at 36 months;Acceptability of procedures measured using comparison of attrition rates between groups at 36 months;Suitability of assessment procedures measured using completion rates at 36 months;The acceptability of the lifestyle programme measured using session compliance data at the 3-month follow-up visit;Exercise safety measured using the number and type of adverse events that occur in each group at 36 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Peripheral arterial disease severity measured using the Ankle Brachial Pressure Index (ABPI) at 3 and 6 months 2. Health-related quality of life measured using the EQ-5D-5L questionnaire at 3 and 6 months 3. CVD event history (since baseline) measured using patient recall of events at 3 and 6 months 4. Functional walking capacity measured using a 6 Minute Walking Test at 3 and 6 months | — |
Countries
England, United Kingdom
Contacts
Public ContactTom Parkington
Outcome results
None listed