Peripheral arterial disease, intermittent claudication
Conditions
Interventions
Participants will receive standard care, meaning SET first, with endovascular or open revascularization in case of insufficient effect.
Sponsors
Catharina Hospital Eindhoven
Eligibility
Inclusion criteria
Inclusion criteria: - Intermittent claudication (IC) due to peripheral arterial disease (PAD; Fontaine II, Rutherford 1-3) - Ankle brachial index (ABI) 0.15 after an exercise test. - Candidate for supervised exercise therapy (SET) as a primary treatment, at the discretion of the treating vascular surgeon. - Recent or planned imaging of at least the aortoiliac and femoropopliteal tract (within 6 months of SET initiation): either colour Duplex Scanning or computed tomography angiography (CTA) or magnetic resonance angiography (MRA). - Signed informed consent form.
Exclusion criteria
Exclusion criteria: - Advanced PAD beyond IC (i.e. ischemic rest pain and/or ulcers, Fontaine >II, Rutherford 4-6). - High probability of non-adherence to physician¡¦s, or physical therapist¡¦s follow-up requirements. - Current participation in a concurrent trial that may confound study results. - Vascular intervention as primary treatment, at the discretion of the treating vascular surgeon. - Prior SET, performed in accordance with the guidelines of the Dutch Society for Physical Therapists, in the previous 12 months. - Prior revascularization in the lower-extremities in the previous 12 months. - Neurogenic/venous/orthopedic claudication more dominant than arterial claudication complaints.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in maximum walking distance on a standardized treadmill test after 3, 6 and 12 months of SET. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Change in functional walking distance on a standardized treadmill test after 3, 6 and 12 months of SET. - Change in Six-Minute Walk Test (6MWT) performance after 3, 6 and 12 months of SET. - Change in Vascular Quality of Life Questionnaire-6 (VascuQoL-6) and WHOQOL-BREF outcomes at 3 and 6 months, and 1, 2, and 5 years, follow-up. - Freedom from vascular interventions for the lower-extremities, at 6 months and 1, 2, and 5 years, follow-up. - Achievement of the main treatment goal, as drafted by the physical therapist and patient at the start of the SET program, and indicated in the feedback letter after 3, 6 and 12 months of SET. - Freedom from major adverse cardiovascular events at 1, 2 and 5 years, follow-up. - To determine whether specific personality traits (extraversion, neuroticism, conscientiousness, self-control, barrier self-efficacy, anxiety, depression, and optimism) measured at baseline are predictive of the clinical outcomes of SET. - Change in barrier self-efficacy after 3, 6 and 12 months of SET. | — |
Contacts
Public ContactJoep A.W. Teijink
Department of Vascular Surgery Catharina Hospital
Outcome results
None listed