The ELECT registry is a multicenter prospective cohort study. Study enrolment is open to consecutively enrolled subjects who, in the opinion of their treating vascular surgeon, are candidates for SET. This study will record diagnostic- and outcome measures that are performed as part of the usual clinical routine (described in vascular surgery and/or physical therapy guidelines), supplemented by a questionnaire with 11 predefined questions. This additional questionnaire is short, contains no intrusive questions, and will only be carried out at three time-points (1, 2, and 5 years after inclusion).
To ensure adequate data collection, the participating centers are recommended to schedule the subjects’ follow-up visit(s) based on the current standard care as prescribed by the Dutch guidelines, which is at 3 to 6 months. At this moment, the decision to either continue conservative management, or treat invasively (endovascular or open revascularization) is generally made. SET is performed by qualified physical therapists according to usual practice (specified in the physical therapy guidelines. A typical SET program contains up to 37 individual sessions, spanning 3 to 12 months. A session consists of 30 minutes of treadmill-based or track-based exercise. This will generally be performed at least three times a week in the first four weeks and one to two times a week for the next eight weeks. After that, there is a maintenance phase during which SET will be performed for one to two times a month. As stated in the guidelines, the physical therapist performs several outcome measurements at 3, 6, 9 and 12-months follow-up.
To investigate the study’s objectives, data obtained in this standard follow-up routine will be recorded prospectively (Figure 1). Although this trial does not hamper routine hospital or physical therapy treatment for the participants, privacy laws require that each subject must authorize the treating physician(s), therapists and institutions to release their medical information. Each subject must sign either a Patient Informed Consent (PIC) form or a Patient Data Release (PDR) form before any data can be sent to the coordinating center. Additionally, the 11-part questionnaire specifically designed for this study’s aim to assess longer term outcomes, will be administered 1, 2, and 5 years after inclusion by the coordinating investigator, either by telephone or mail.