Personalised Multicomponent Exercise Programme in Peripheral Arterial Disease

Recruiting now · Not applicable

Conditions studied: Peripheral Arterial Disease, Intermittent Claudication

In brief

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.

Key facts

Study ID

NCT06410521

Run by

University of Trás-os-Montes and Alto Douro

People needed

40

Starts

2025-06-20

Expected to finish

2027-12-01

Last updated by the study team

2025-06-27

Who can join

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

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Hospital Centre Hospitalar de Trás-os-Montes e Alto Douro — Vila Real, Portugal (enrolling)
• Research Centre in Sports Sciences, Health Sciences and Human Development — Vila Real, Portugal (enrolling)
• University of Trás-os-Montes and Alto Douro — Vila Real, Portugal (enrolling)

Full record on ClinicalTrials.gov

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