CT Body Composition as Predictor of Exercise Therapy Outcome in Peripheral Arterial Disease

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNemocnice AGEL Trinec-Podlesi a.s.

About this trial

Supervised exercise therapy (SET) is the recommended first treatment for patients with leg artery disease (peripheral arterial disease, PAD) causing pain when walking. However, approximately 40% of patients do not benefit meaningfully and go on to require a procedure to open the blocked arteries within three months. This study investigates whether body composition measurements - specifically the quality of muscle and the amount of belly fat - taken from a CT scan already performed as part of routine care, can identify before treatment begins which patients are unlikely to respond to exercise therapy. If confirmed, this approach would allow doctors to use information from a scan patients are already having, with no additional tests, to better match patients to the right treatment from the start.

Eligibility criteria

Qualifiers

Age 18 years or older

Confirmed peripheral arterial disease (PAD) defined by at least one of: resting ankle-brachial index (ABI) ≤0.90, duplex ultrasonography demonstrating ≥50% stenosis in a relevant lower extremity vessel, or CT angiography (CTA) or magnetic resonance angiography (MRA) demonstrating flow-limiting lower extremity arterial disease

Fontaine stage IIa or IIb intermittent claudication

Scheduled for the institutional 36-session supervised exercise therapy (SET) programme

Disqualifiers

Fontaine stage III or IV peripheral arterial disease (rest pain or tissue loss; critical limb-threatening ischaemia)

Ipsilateral lower extremity revascularisation within 6 months prior to enrolment

Absolute contraindication to structured exercise (e.g., unstable coronary artery disease, severe pulmonary hypertension, uncontrolled arrhythmia, or other condition precluding participation in a supervised treadmill and resistance exercise programme)

Cognitive impairment (Mini-Mental State Examination [MMSE] score <24)

Trial design

Treatments tested in this trial

  • SET physiotherapy
  • CT scan

Treatment groups

No treatment groups listed

Locations

This trial has no locations