Personalisation of Non-surgical Treatment in Peripheral Arterial Disease Using a Multicomponent Exercise Approach

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Portugal
Hospital Centre Hospitalar de Trás-os-Montes e Alto Douro
RECRUITING
Vila Real
Research Centre in Sports Sciences, Health Sciences and Human Development
RECRUITING
Vila Real
University of Trás-os-Montes and Alto Douro
RECRUITING
Vila Real
Contact Information
Primary
Catarina Abrantes, Ph.D.
abrantes@utad.pt
259350000
Backup
Daniel Santarém, M.Sc.
danielrs@utad.pt
259350000
Time Frame
Start Date: 2025-06-20
Estimated Completion Date: 2027-12
Participants
Target number of participants: 40
Treatments
Experimental: Supervised multicomponent exercise
Experimental arm will perform the supervised exercise programme three times a week, with each session taking approximately 60-80 minutes for a period of 12 weeks.
Active_comparator: Usual care
Active comparator arm will be advised to lifestyle modification and to perform regular walking for a period of 12 weeks.
Sponsors
Leads: University of Trás-os-Montes and Alto Douro
Collaborators: Hospital Centre Hospitalar de Trás-os-Montes e Alto Douro, Research Center in Sports Sciences, Health Sciences and Human Development

This content was sourced from clinicaltrials.gov