There is no clinically relevant difference regarding changes in maxium walking distance between intermittent claudication patients with aortoiliac and femoropopliteal disease after supervised exercise therapy.
ID
Bron
Verkorte titel
Aandoening
Peripheral arterial disease, intermittent claudication
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Change in maximum walking distance on a standardized treadmill test after 3, 6 and 12 months of SET.
Achtergrond van het onderzoek
Despite guideline recommendations advocating conservative management before invasive treatment in intermittent claudication, early revascularisation remains widespread in patients with favourable anatomy. The aim of the ELECT Registry is to determine the effect of the location of stenosis on the outcomes of supervised exercise in patients with intermittent claudication due to peripheral arterial disease.
This multicentre prospective cohort study aims to enrol 320 patients in ten vascular centres across the Netherlands. All patients diagnosed with intermittent claudication (peripheral arterial disease: Fontaine II/Rutherford 1-3), who are considered candidates for supervised exercise therapy by their own physicians are appropriate to participate. Participants will receive standard care, meaning supervised exercise therapy first, with endovascular or open revascularization in case of insufficient effect.
For the primary objectives, patients are grouped according to anatomical characteristics of disease (aortoiliac, femoropopliteal, or multilevel disease) as apparent on the preferred imaging modality in the participating centre (either duplex, CTA, or MRA). Changes in walking performance (treadmill tests, 6-minute walk test) and quality of life (QoL; Vascular QoL Questionnaire-6, World Health Organization QoL Questionnaire-Bref) will be compared between groups, after multivariate adjustment for possible confounders. Furthermore, freedom from revascularization and major adverse cardiovascular disease events, and attainment of the treatment goal between anatomical groups will be compared.
Doel van het onderzoek
There is no clinically relevant difference regarding changes in maxium walking distance between intermittent claudication patients with aortoiliac and femoropopliteal disease after supervised exercise therapy.
Onderzoeksopzet
Timepoints are mentioned with the outcome measures of interest above. For the primary outcome: 3, 6 and 12 months.
Onderzoeksproduct en/of interventie
Participants will receive standard care, meaning SET first, with endovascular or open revascularization in case of insufficient effect.
Publiek
Catharina Hospital
Joep A.W. Teijink
Michelangelolaan 2, 5623 EJ Eindhoven
P.O. Box 1350,
Eindhoven 5602 ZA
The Netherlands
+31 40 2396349
joep.teijink@catharinaziekenhuis.nl
Wetenschappelijk
Catharina Hospital
Joep A.W. Teijink
Michelangelolaan 2, 5623 EJ Eindhoven
P.O. Box 1350,
Eindhoven 5602 ZA
The Netherlands
+31 40 2396349
joep.teijink@catharinaziekenhuis.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- Intermittent claudication (IC) due to peripheral arterial disease (PAD; Fontaine II, Rutherford 1-3)
- Ankle brachial index (ABI) <0.9 or drop in 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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- 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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL7135 |
| NTR-old | NTR7332 |
| Ander register | MEC-U : W17.071 |