NCT07433309Not yet recruiting
CT Body Composition as Predictor of Exercise Therapy Outcome in Peripheral Arterial Disease
CT Body Composition Predicts Supervised Exercise Response in Peripheral Arterial Disease: A Protocol
Source: ClinicalTrials.gov · Last updated 25 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 128 (estimated)
- First submitted
- 20 Feb 2026
- Start date
- 1 Jun 2026
- Primary completion date
- 31 Dec 2030
- Lead sponsor
- Nemocnice AGEL Trinec-Podlesi a.s.
- Diseases
- Obesity
- NCT number
- NCT07433309
What you commit to
- Study type: Observational
- Planned participants: 128
- From 1 Jun 2026 to the primary completion date, 31 Dec 2030
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Ipsilateral lower extremity revascularisation within 6 months prior to enrolment
Other illness
- Fontaine stage III or IV peripheral arterial disease (rest pain or tissue loss; critical limb-threatening ischaemia)
- 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
Other
- Estimated life expectancy less than 12 months
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.