Table 1 Details of design and methods in the SUNFIT trial

Study design

Prospective, multi-center, randomized clinical trial with three treatment arms; with a confirmatory intention-to-treat non-inferiority analysis of the main endpoint (6MWT) and exploratory superiority testing of secondary trial endpoints

ClinicalTrials.gov identifier

NCT02341716

Inclusion criteria

Established mild to severe IC for > 6 months, confirmed to be of vascular origin, with an ABI of less than 0.9 and/or a post-exercise ABI drop of ≥ 30%

Exclusion criteria

- Previous revascularization for IC performed within three months

- Revascularization within 12 months deemed necessary by the vascular surgeon

- Cognitive dysfunction

- Inability to perform the 6MWT

- Inability to speak or understand the Swedish language

Recruitment

Patients were recruited among patients referred for evaluation regarding revascularization to the vascular surgery outpatient clinics at the Departments of Vascular Surgery at Sahlgrenska University Hospital, the Region Hospital of Karlstad and Södra Älvsborg Hospital, Sweden

Recruitment period

September 2014 to January 2018

Randomization and blinding

Randomization using an adaptive stratified computerized randomization procedure (multifactorial minimization) [13] Endpoint evaluators were blinded to group affiliations

Follow up visits

At three, six and 12 months for endpoint evaluations at the Physiotherapy Department; and a revisit to the vascular surgeon at 12 months

Classification of exercise adherence

Full adherence: attendance at ≥ 80% of the exercise sessions at recommended exercise intensity for ≥ 30 min per session

Partial adherence: attendance at ≥ 20 to < 80% of exercise sessions, irrespective of exercise intensity

Non-adherence: attendance at < 20% of exercise sessions