Personalisation of Non-surgical Treatment in Peripheral Arterial Disease Using a Multicomponent Exercise Approach
Trial ID: NCT06410521
Status: RECRUITING
Study type: INTERVENTIONAL
Phase: NA
Start date: 2025-06-20
Completion date: 2027-12
Sponsor: University of Trás-os-Montes and Alto Douro
Collaborators: Research Center in Sports Sciences, Health Sciences and Human Development; Hospital Centre Hospitalar de Trás-os-Montes e Alto Douro
Conditions: Peripheral Arterial Disease; Intermittent Claudication
Interventions: Exercise; Usual care
Locations: Hospital Centre Hospitalar de Trás-os-Montes e Alto Douro; Research Centre in Sports Sciences, Health Sciences and Human Development; University of Trás-os-Montes and Alto Douro
Countries: Portugal; Portugal; Portugal
Enrollment: 40
Age range: 18 Years - None
Sex: MALE

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.

Outcomes:
Pain-free walking distance; Maximum walking distance; Percentage of muscle deoxygenation; Muscle reoxygenation time