What is this study trying to find out about peripheral arterial disease?

This study is evaluating how a personalised exercise program combining cardiovascular and resistance training affects symptoms and function in people with peripheral arterial disease. Researchers aim to use wearable technology and artificial intelligence to tailor exercise based on individual responses. The study is sponsored by the University of Trás-os-Montes and Alto Douro.

Who may be eligible for this peripheral arterial disease clinical trial?

Men aged 18 years or older with stable peripheral arterial disease and mild to moderate leg pain during walking may be eligible. Participants must be able to walk on a treadmill and not have recent treatments or other health conditions that limit exercise. Please review eligibility criteria for more details.

Is there any cost to participate in this peripheral arterial disease clinical trial?

Study-related care, including the supervised exercise program and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants can plan accordingly for any travel needs.

Actively Recruiting

Phase Not Applicable

Age: 18Years +

MALE

ID06410521

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

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

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Peripheral arterial disease PAD is a condition that mainly affects blood flow in the lower limbs and causes symptoms like pain and cramps during activity, known as intermittent claudication. Researchers are evaluating a personalised exercise program combining cardiovascular and resistance training to improve how patients with PAD function. This study focuses on using wearable technology and artificial intelligence to monitor patients real-time responses and tailor exercise doses individually. The study involves two groups one receives a supervised multicomponent exercise program three times a week for 12 weeks, including aerobic walking and resistance exercises with progressive intensity based on pain levels. The other group follows usual care with lifestyle advice but no specific exercise program. The exercise sessions last about 60 to 80 minutes, with detailed monitoring using near-infrared spectroscopy and accelerometers to track muscle oxygen levels and movements. Participants will be assessed before and after the 12-week program to measure pain-free and maximum walking distances, muscle oxygenation, muscle strength and power, blood pressure, quality of life, daily walking ability, blood glucose, and physical activity levels. The study uses random assignment to groups and collects data to understand how personalised exercise affects PAD symptoms and function. The total participation time is 12 weeks, with evaluations at the start and end of the study.

CONDITIONS

Brief Title

Personalised Multicomponent Exercise Programme in Peripheral Arterial Disease

Who Can Participate

Age: 18Years +

MALE

Eligibility Criteria

You may qualify if you...

Diagnosed with clinically stable peripheral arterial disease (PAD)
An ankle-brachial index between 0.41 and 0.90 at rest in one or both lower limbs
Mild to moderate claudication symptoms corresponding to Fontaine Stage IIa and IIb
History of ambulatory leg pain
Ambulatory leg pain confirmed by treadmill test
Able to provide written informed consent

You will not qualify if you...

Noncompressible, calcified tibial arteries with resting ankle-brachial index ≥ 1.4
Use of medications influencing claudication (e.g., Cilostazol or Pentoxifylline) within 3 months prior
Previous interventions such as balloon angioplasty, stenting, bypass, or exercise programs
Inability to walk on a treadmill at 3.2 km/h (2 mph)
Participation in another clinical trial or exercise program within the past 3 months
Asymptomatic peripheral arterial disease
Exercise limited by diseases or conditions other than intermittent claudication
Presence of angina pectoris, congestive heart failure, chronic obstructive pulmonary disease, severe arthritis, or limb amputation

Research Team

Catarina Abrantes, Ph.D.

Daniel Santarém, M.Sc.

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