Personalised Multicomponent Exercise Programme in Peripheral Arterial Disease

NCT06410521 | Recruiting

• 1 other identifier: PASSUS 2.0
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Peripheral Arterial Disease; Intermittent Claudication

Keywords

Peripheral arterial disease; Supervised multicomponent exercise programme

Outcome Measures

Primary Outcomes (4)

• Pain-free walking distance

  Distance until onset of claudication (in meters) will be measured in patients undergoing the graded treadmill exercise test (Gardner-Skinner protocol).

  Baseline and 12 weeks

• Maximum walking distance

  Walking distance until maximum claudication (in meters) will be measured in patients undergoing the graded treadmill exercise test (Gardner-Skinner protocol).

  Baseline and 12 weeks

• Percentage of muscle deoxygenation

  The percentage of muscle deoxygenation (in %) will be measured in patients undergoing the graded treadmill exercise test (Gardner-Skinner protocol).

  Baseline and 12 weeks

• Muscle reoxygenation time

  The muscle reoxygenation time (in seconds) will be measured in patients undergoing the graded treadmill exercise test (Gardner-Skinner protocol).

  Baseline and 12 weeks

Secondary Outcomes (13)

• Pain-free walking distance

  Baseline and 12 weeks

• Maximum walking distance

  Baseline and 12 weeks

• Percentage of muscle deoxygenation

  Baseline and 12 weeks

• Muscle reoxygenation time

  Baseline and 12 weeks

• Lower limb muscle strength assessment

  Baseline and 12 weeks

Other Outcomes (3)

• Ankle-brachial index

  Baseline and 12 weeks

• Body composition

  Baseline and 12 weeks

• Cross-sectional area of the gastrocnemius medialis muscle

  Baseline and 12 weeks

Study Arms (2)

Supervised multicomponent exercise

EXPERIMENTAL

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.

Behavioral: Exercise

Usual care

ACTIVE COMPARATOR

Active comparator arm will be advised to lifestyle modification and to perform regular walking for a period of 12 weeks.

Behavioral: Usual care

Interventions

Exercise BEHAVIORAL

Patients randomised to the intervention arm will undergo non-consecutive training sessions three times a week for a period of 12 weeks. The training session is divided into an aerobic and a resistance training component, with a 5-min warm-up (stretching exercises) and a 5-min cool-down (stretching and relaxing exercises). The cardiovascular component will comprise a progressive exercise duration from 30 to 40 minutes, an exercise intensity promoting moderate to severe claudication pain between 8-12 minutes, with rest time until the pain disappears, and a personalised load progression manipulated based on the claudication pain level, reaching a total of 60 minutes of walking per session. The resistance training component will comprise dynamic muscle contraction exercises (Leg extension, unilateral hip extension, and standing calf raise), with a load progression from 50% of 1-estimated one repetition maximum (e-RM) to 80% of 1-eRM.

Supervised multicomponent exercise

Usual care BEHAVIORAL

Patients randomised to the active comparator arm will be advised about the importance of lifestyle modification (including general advice to increase walking but without specific recommendations about the exercise program) for a period of 12 weeks.

Usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Trás-os-Montes and Alto Douro: lead
• Research Center in Sports Sciences, Health Sciences and Human Development: collaborator
• Hospital Centre Hospitalar de Trás-os-Montes e Alto Douro: collaborator

Study Sites (3)

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

Vila Real, 5000-508, Portugal

RECRUITING

Research Centre in Sports Sciences, Health Sciences and Human Development

Vila Real, 5000-801, Portugal

RECRUITING

University of Trás-os-Montes and Alto Douro

Vila Real, 5000-801, Portugal

RECRUITING

Related Publications (5)

• Aboyans V, Ricco JB, Bartelink MEL, Bjorck M, Brodmann M, Cohnert T, Collet JP, Czerny M, De Carlo M, Debus S, Espinola-Klein C, Kahan T, Kownator S, Mazzolai L, Naylor AR, Roffi M, Rother J, Sprynger M, Tendera M, Tepe G, Venermo M, Vlachopoulos C, Desormais I; ESC Scientific Document Group. 2017 ESC Guidelines on the Diagnosis and Treatment of Peripheral Arterial Diseases, in collaboration with the European Society for Vascular Surgery (ESVS): Document covering atherosclerotic disease of extracranial carotid and vertebral, mesenteric, renal, upper and lower extremity arteriesEndorsed by: the European Stroke Organization (ESO)The Task Force for the Diagnosis and Treatment of Peripheral Arterial Diseases of the European Society of Cardiology (ESC) and of the European Society for Vascular Surgery (ESVS). Eur Heart J. 2018 Mar 1;39(9):763-816. doi: 10.1093/eurheartj/ehx095. No abstract available.

  PMID: 28886620 BACKGROUND

• Baltrunas T, Mosenko V, Mackevicius A, Dambrauskas V, Asakiene I, Rucinskas K, Narmontas P. The use of near-infrared spectroscopy in the diagnosis of peripheral artery disease: A systematic review. Vascular. 2022 Aug;30(4):715-727. doi: 10.1177/17085381211025174. Epub 2021 Jun 10.

  PMID: 34112030 BACKGROUND

• Cornelis N, Chatzinikolaou P, Buys R, Fourneau I, Claes J, Cornelissen V. The Use of Near Infrared Spectroscopy to Evaluate the Effect of Exercise on Peripheral Muscle Oxygenation in Patients with Lower Extremity Artery Disease: A Systematic Review. Eur J Vasc Endovasc Surg. 2021 May;61(5):837-847. doi: 10.1016/j.ejvs.2021.02.008. Epub 2021 Mar 30.

  PMID: 33810977 BACKGROUND

• Nordanstig J, Behrendt CA, Bradbury AW, de Borst GJ, Fowkes F, Golledge J, Gottsater A, Hinchliffe RJ, Nikol S, Norgren L. Peripheral arterial disease (PAD) - A challenging manifestation of atherosclerosis. Prev Med. 2023 Jun;171:107489. doi: 10.1016/j.ypmed.2023.107489. Epub 2023 Apr 7.

  PMID: 37031910 BACKGROUND

• Perrey S, Ferrari M. Muscle Oximetry in Sports Science: A Systematic Review. Sports Med. 2018 Mar;48(3):597-616. doi: 10.1007/s40279-017-0820-1.

  PMID: 29177977 BACKGROUND

MeSH Terms

Conditions

Peripheral Arterial Disease; Intermittent Claudication

Interventions

Exercise

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Catarina Abrantes, Ph.D.

  University of Trás-os-Montes and Alto Douro, Vila Real, Portugal

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Catarina Abrantes, Ph.D.

CONTACT

259350000; abrantes@utad.pt

Daniel Santarém, M.Sc.

CONTACT

259350000; danielrs@utad.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study design will comprise two evaluation moments: initial evaluation (M0 - 0 week) and final evaluation (M1 - 12 weeks after). After M0 patients will be randomised into the intervention arm (experimental group) and comparator arm (usual care group). The intervention arm will perform supervised exercise (cardiovascular and resistance training) three times a week for 12 weeks and the comparator arm will receive information regarding standard lifestyle modification but without specific recommendations about the exercise programme.

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: May 13, 2024
• Study Start: June 20, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 27, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

PT (3)