SUPERvised exercise therapy or immediate PTA for intermittent claudication in patients with an iliac artery obstruction: A randomized controlled trial. SUPER study.

Recruiting

• Conditions: Intermittent Claudication; Claudicatio IntermittensSupervised Exercise Therapy; gesuperviseerde looptrainingPercutaneous Transluminal Angioplasty; Percutane Transluminale AngioplastiekIliac artery obstruction; Arteria Iliaca obstructie

• Registration Number: NL-OMON25926
• Lead Sponsor: Academic Medical Center (AMC) P.O. Box 22660 1100 DD Amsterdam The Netherlands +31 (0)20 5669111

Brief Summary

/A

Detailed Description

Not available

Study Timeline

• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 400

Inclusion Criteria

1. Age 18 years or older;

2. Disabling claudication as defined by surgeon based on patient’s history;

Exclusion Criteria

1. Life expectancy < 3 months;

2. Patient is unable to complete self-reported questionnaires (insufficiently reading or speaking the Dutch language, cognitive disorders, etc);

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Disease specific Quality of Life (VascuQoL);<br /><br>2. Maximum Walking Distance (on a standardized treadmill test with a speed of 3.2 km/h at 10% incline after 1 year).

Secondary Outcome Measures

Name	Time	Method
1. Painfree Walking Distance (on a standardized treadmill test with a speed of 3.2 km/h at 10% incline);<br /><br>2. Functional Status ( ALDS);<br /><br>3. Generic Quality of Life ( SF-36 and EQ5D);<br /><br>4. Complications related to interventions;<br /><br>5. Treatment failures;<br /><br>6. Costs.