NCT06410521 Personalised Multicomponent Exercise Programme in Peripheral Arterial Disease
| NCT ID | NCT06410521 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Trás-os-Montes and Alto Douro |
| Condition | Peripheral Arterial Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-06-20 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2025-06-20 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Peripheral arterial disease (PAD) is characterised as an atherosclerotic disease, most common in the lower limbs (aortoiliac, femoropopliteal, and infrapopliteal arterial segments), which causes a decrease in blood flow to the areas adjacent to and posterior to the affected area. Intermittent claudication (IC) is the most common symptom in this disease that appears with exertion and relieves with rest, causing fatigue, cramps, discomfort, or pain in the lower limbs due to limited blood flow to the affected muscles. Supervised physical exercise has emerged as the first line of intervention in improving the symptoms of intermittent claudication and disease progression, and in the last decade there has been an exponential increase in the use of wearable technologies to monitor dose-response. However, the approach used is still simplistic because it is not personalised. In other words, patients with similar diagnoses and symptoms get the same treatment, without personalising the stimulus according to their exercise responses and level of adaptation. With this in mind, this study aims to monitoring the real-time response of a multicomponent exercise programme (cardiovascular and resistance training) to personalise the dose-response, and use artificial intelligence models to gather and analyse vast amounts of data towards grouping/differentiating based on individual responses. The main hypothesis is that a supervised multicomponent exercise programme will improve the functional capacity of patients with PAD in a cluster personalised approach.
Eligibility Criteria
Inclusion Criteria: * Diagnosed with clinically stable PAD; * An ankle-brachial index (ABI) between 0.41-0.90 at rest in one or both lower limbs; * Mild to moderate claudication, corresponding to Fontaine Stage IIa and IIb; * A history of ambulatory leg pain; * Ambulatory leg pain confirmed by treadmill test; * Able to provide written consent. Exclusion Criteria: * Noncompressible, calcified, tibial arteries (resting ABI ≥ 1.4); * Use of medication that could influence claudication (e.g. Cilostazol or Pentoxifylline) 3 months prior to investigation; * Previous intervention (e.g. balloon angioplasty, stenting, bypass, exercise programme); * Inability to walk on a treadmill at a speed of 3.2 km/h (2 mph); * Participation in the past 3 months in a clinical trial or exercise program; * Asymptomatic PAD determined from the medical history; * Exercise limited by factors other diseases or conditions than intermittent claudication; * Angina pectoris, congestive heart failure, chronic obstructive pulmonary disease, severe arthritis, or limb amputation.
Contact & Investigator
Catarina Abrantes, Ph.D.
PRINCIPAL INVESTIGATOR
University of Trás-os-Montes and Alto Douro, Vila Real, Portugal
Frequently Asked Questions
Who can join the NCT06410521 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Peripheral Arterial Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06410521 currently recruiting?
Yes, NCT06410521 is actively recruiting participants. Contact the research team at abrantes@utad.pt for enrollment information.
Where is the NCT06410521 trial being conducted?
This trial is being conducted at Vila Real, Portugal, Vila Real, Portugal, Vila Real, Portugal.
Who is sponsoring the NCT06410521 clinical trial?
NCT06410521 is sponsored by University of Trás-os-Montes and Alto Douro. The principal investigator is Catarina Abrantes, Ph.D. at University of Trás-os-Montes and Alto Douro, Vila Real, Portugal. The trial plans to enroll 40 participants.