Actively Recruiting

Phase Not Applicable
Age: 18Years +
MALE
NCT06410521

Personalised Multicomponent Exercise Programme in Peripheral Arterial Disease

Led by University of Trás-os-Montes and Alto Douro · Updated on 2025-06-27

40

Participants Needed

3

Research Sites

127 weeks

Total Duration

On this page

Sponsors

U

University of Trás-os-Montes and Alto Douro

Lead Sponsor

R

Research Center in Sports Sciences, Health Sciences and Human Development

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Personalised Multicomponent Exercise Programme in Peripheral Arterial Disease

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with clinically stable peripheral arterial disease (PAD)
  • Ankle-brachial index (ABI) between 0.41 and 0.90 at rest in one or both lower limbs
  • Mild to moderate claudication, Fontaine Stage IIa or IIb
  • History of ambulatory leg pain
  • Ambulatory leg pain confirmed by treadmill test
  • Able to provide written consent
Not Eligible

You will not qualify if you...

  • Noncompressible, calcified tibial arteries (resting ABI 21241.4)
  • Use of medications affecting claudication (e.g., Cilostazol or Pentoxifylline) within 3 months prior
  • Previous interventions like balloon angioplasty, stenting, bypass, or exercise programme
  • Unable to walk on treadmill at 3.2 km/h (2 mph)
  • Participation in clinical trial or exercise program in past 3 months
  • Asymptomatic PAD based on medical history
  • Exercise limited by other diseases or conditions besides intermittent claudication
  • Presence of angina pectoris, congestive heart failure, COPD, severe arthritis, or limb amputation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

Hospital Centre Hospitalar de Trás-os-Montes e Alto Douro

Vila Real, Portugal, 5000-508

Actively Recruiting

2

Research Centre in Sports Sciences, Health Sciences and Human Development

Vila Real, Portugal, 5000-801

Actively Recruiting

3

University of Trás-os-Montes and Alto Douro

Vila Real, Portugal, 5000-801

Actively Recruiting

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Research Team

C

Catarina Abrantes, Ph.D.

CONTACT

D

Daniel Santarém, M.Sc.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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