Personalised multicomponent exercise program for peripheral arterial disease

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

This trial tests whether a personalised, continuously monitored exercise program using heart-rate and muscle-oxygen sensors can help people with peripheral arterial disease and intermittent claudication walk farther and have less leg pain.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: University of Trás-os-Montes and Alto Douro (Academic / other)
• Locations: 3 sites (Vila Real and 2 other locations)
• Trial ID: NCT06410521 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults with clinically stable peripheral arterial disease and intermittent claudication (ABI 0.41–0.90), able to walk on a treadmill at 3.2 km/h and willing to attend supervised exercise sessions.

Not a fit: Patients with noncompressible arteries (ABI ≥ 1.4), recent vascular interventions or recent participation in exercise programs, those taking medications that alter claudication, individuals with severe cardiac disease limiting exercise, or those unable to walk safely on a treadmill are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the approach could increase walking distance and reduce claudication pain by tailoring exercise intensity to each patient's muscle oxygen and heart-rate responses.

How similar studies have performed: Supervised exercise is an established treatment for claudication, but continuous NIRS-guided personalization with high-resolution accelerometry is relatively new and has limited prior clinical trial evidence.

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.

Where this trial is running

Vila Real and 2 other locations

• 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.

Conditions Peripheral Arterial Disease; Intermittent Claudication; Peripheral arterial disease; Supervised multicomponent exercise programme