Table 1.

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.