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

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Conditions studied: Sarcopenia, Body Composition, Sarcopenic Obesity, Peripheral Arterial Disease

In brief

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.

Key facts

Study ID

NCT07433309

Run by

Nemocnice AGEL Trinec-Podlesi a.s.

People needed

128

Starts

2026-06-01

Expected to finish

2031-01-31

Last updated by the study team

2026-02-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Existing CTA with an axial slice at the L3 vertebral level suitable for automated body composition analysis
• Capacity to provide written informed consent

You may not qualify if…

• 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)
• Active malignancy or systemic condition expected to substantially alter body composition independently of the exercise intervention during the study period
• Estimated life expectancy less than 12 months

Full record on ClinicalTrials.gov

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