Personalised multicomponent exercise program for peripheral arterial disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Participants with symptomatic peripheral arterial disease will be enrolled and undergo baseline testing including ankle-brachial index and treadmill-confirmed claudication. An experimental group will receive supervised multicomponent cardiovascular and resistance training personalized in real time using continuous heart-rate monitoring and near-infrared spectroscopy (SmO2) together with high-precision accelerometry, while controls receive usual care. Wearable sensors will track deoxygenation/reoxygenation and movement patterns to adjust exercise dose and intensity throughout the program. Outcomes will include walking performance, claudication symptoms, and physiological responses to determine whether personalized, continuously monitored training provides greater benefit than standard approaches.

Why it matters

Who can join: the full rules

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 6 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's running

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

Study contacts

• Principal investigator: Catarina Abrantes, Ph.D. — University of Trás-os-Montes and Alto Douro, Vila Real, Portugal
• Study coordinator: Catarina Abrantes, Ph.D.
• Email: abrantes@utad.pt
• Phone: 259350000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.