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Routine CT scan may reveal who needs surgery instead of exercise for leg pain

NCT ID NCT07433309

Knowledge-focused Sponsor: Nemocnice AGEL Trinec-Podlesi a.s. Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether a CT scan already done for routine care can predict which patients with leg artery disease will improve with supervised exercise therapy. About 40% of patients don't get enough benefit from exercise and need a procedure to open blocked arteries. Researchers will measure muscle quality and belly fat from the CT scan and see if these factors predict exercise success in 128 participants over 12 weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
supervised exercise therapy (SET)
What this could lead to
If successful, this could allow doctors to use a routine CT scan to identify which patients are unlikely to improve with exercise, helping them choose the right treatment sooner.
What could go wrong
This is an early-stage observational study, not a treatment trial. It may not confirm that CT scans reliably predict exercise response, and results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 128 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Jan 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Consecutive adult patients with Fontaine IIa-IIb intermittent claudication attending the vascular surgery outpatient clinic at the Complex Cardiovascular Centre, Hospital AGEL Trinec-Podlesi, Trinec, Czech Republic, who are scheduled for the institutional supervised exercise therapy programme and have an existing CT angiography with an analysable L3 axial slice.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

intermittent vascular claudication peripheral arterial disease Sarcopenia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Body composition Peripheral arterial disease Sarcopenia Sarcopenic obesity

How to take part

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  1. The official record

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Other studies related to the condition(s) this trial covers.