Study registration items
| Data category | Information |
| Primary registry and identifying number | ClinicalTrials.gov NCT04042311 (Workstream 2) |
| Date of registration in primary registry | 01/08/2019 |
| Source of monetary or material support | National Institute for Health Research, Research for Patient Benefit programme |
| Primary Sponsor | Hull University Teaching Hospitals NHS Trust |
| Contact for public queries | JL (Judith.Long@hey.nhs.uk) |
| Contact for scientific queries | SP (Sean.Pymer@hey.nhs.uk) |
| Public title | High INtensity Interval Training In pATiEnts with intermittent claudication (INITIATE) |
| Scientific title | INITIATE: a multicentre, proof-of-concept, prospective interventional study |
| Countries of recruitment | UK |
| Health condition or problem studied | Intermittent claudication |
| Intervention | High-intensity interval training |
| Key inclusion and exclusion criteria | Ages eligible for the study: ≥18 years Sexes eligible for the study: all Accepts healthy volunteers: no |
| Inclusion criteria: Community dwelling adults aged 18 or over. ABPI <0.9 at rest or a drop of more than 20 mm Hg after exercise testing Ability to walk unaided English speaking and able to comply with exercise instructions | |
| Exclusion Criteria: Unable to provide informed consent Critical limb threatening ischaemia/rest pain/tissue loss Active cancer treatment Significant comorbidities precluding safe participation in exercise testing and / or training according to the American College of Sports Medicine guidelines28 Resting/uncontrolled tachycardia (>100 bpm) and/or resting/uncontrolled hypertension (systolic blood pressure >180 mm Hg or diastolic blood pressure >100 mm Hg) Symptomatic hypotension | |
| Additional exclusion criteria: | Exercise-induced myocardial ischaemia or significant haemodynamic compromise (manifesting as anginal symptoms, significant ECG changes or an abnormal blood pressure response). |
| Study type | Interventional |
| Allocation: single group assignment | |
| Primary purpose: Treatment | |
| Date of first enrolment: | 12/08/2019 |
| Target sample size: | 40 patients |
| Recruitment status: | Recruiting |
| Primary outcomes: | Safety: occurrence of adverse and serious adverse events Feasibility: eligibility, recruitment and completion rates Tolerability: assessing reasons for withdrawal, and identifying ability to reach and maintain the required intensity. |
| Secondary outcomes: | Acceptability: patient feedback via semistructured interview Efficacy: pain-free and maximal walking distance Quality of life Cardiorespiratory measures Ankle brachial pressure index |
ABPI, Ankle-Brachial Pressure Index.