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

NCT07433309 | Not Yet Recruiting

• 1 other identifier: EK-314-22-PAD-BC
• Study Type: observational
• Target: 128
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Sarcopenia; Body Composition; Sarcopenic Obesity; Peripheral Arterial Disease

Keywords

Peripheral arterial disease; intermittent claudication; supervised exercise therapy; computed tomography body composition; myosteatosis; visceral adipose tissue; sarcopenic obesity; treatment outcome prediction

Outcome Measures

Primary Outcomes (1)

• Composite supervised exercise therapy treatment success at 3 months

  Binary composite endpoint requiring both: (1) Functional improvement - absolute increase in maximum walking distance (MWD) ≥50 m OR relative increase ≥50% from baseline on standardised graded treadmill testing (3.2 km/h); AND (2) Revascularisation-free status - no endovascular or surgical lower extremity revascularisation during the 3-month programme period. Treatment success = both criteria met; treatment failure = failing either criterion. MWD assessed by trained physiotherapist blinded to CT body composition data. Revascularisation events independently adjudicated by a vascular surgeon blinded to body composition predictor values.

  3 months from enrolment (end of supervised exercise therapy programme)

Interventions

SET physiotherapy PROCEDURE

36-session AHA 2019-concordant supervised exercise programme delivered over 12 weeks (3 sessions per week, 60 minutes each). Each session consists of 45 minutes of structured treadmill and resistance exercise plus 15 minutes of patient education on vascular risk factor management. Treadmill protocol: 3.2 km/h, walking to claudication pain level 3 on a four-point scale, resting to level 1, five to six cycles per session. Progression weeks 1-4: speed +0.3 km/h every two weeks (maximum 4.0 km/h); weeks 5-8: grade +1% every two weeks (maximum 3%). Resistance training from week 5 targeting major lower extremity muscle groups (progressing from 2 sets × 10 repetitions to 5 sets at \~70% one-repetition maximum). This is standard clinical care; the study does not allocate participants to exercise.

CT scan RADIATION

Single-slice CT body composition analysis at the L3 vertebral level, extracted opportunistically from existing diagnostic CT angiography. Segmentation performed using AutoMATiCA (U-Net convolutional neural network). Compartments quantified: skeletal muscle (-29 to +150 HU within muscle fascia mask), visceral adipose tissue (-150 to -50 HU within peritoneal cavity), subcutaneous adipose tissue (-190 to -30 HU exterior to body wall), and intramuscular adipose tissue (-190 to -30 HU within muscle fascia, exterior to individual muscle boundaries). A second dedicated CT acquisition is performed at 3 months (T1) for exploratory longitudinal analysis.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

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

Sponsors & Collaborators

• Nemocnice AGEL Trinec-Podlesi a.s.: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum samples stored at -80°C for batched analysis of adiponectin, leptin, and interleukin-6 (IL-6) in a two-phase exploratory sub-study (Phase 1: stratified subsample of 40 participants).

MeSH Terms

Conditions

Sarcopenia; Peripheral Arterial Disease; Intermittent Claudication

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 20, 2026
• First Posted: February 25, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): January 31, 2031
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share