Effects of Combined Aerobic and Resistance Training in Patients With Intermittent Claudication

NCT04302571 | Unknown

• 1 other identifier: APE-IC1
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Exercise training improves walking capacity and regional perfusion in patients with Intermittent Claudication (IC). Endothelial Progenitor Cells (EPCs) and Endothelial Microparticles (EMPs) could play an important role in this process, promoting the healing of the diseased endothelium. The investigators are going to measure EPCs and EMPs in a group of patients with IC and in a control group of healthy individuals before a treadmill test and 2, 24, and 48 hours after the test. Subsequently, a group of IC patients will be randomly assigned to perform a 12-week home-based exercise training program. The investigators expect a significant increase of EMPs and EPCs after acute and chronic physical activity. We expect also a correlation between the increase of EMPs and EPCs and the improvement in walking capacity. Aim of the study is to demonstrate that acutely performed aerobic exercise could be able to promote the mobilization of EMPs and EPCs in patients with IC and that endothelial progenitor cells mobilization could play a pivotal role in exercise induced improvement of walking performance and endothelial function in subjects with IC.

Conditions

Peripheral Arterial Disease; Endothelial Dysfunction

Outcome Measures

Primary Outcomes (5)

• Endothelial Microparticles (EMPs)

  hematological parameter, cells particles released by activated endothelium, measured by cytofluorimetry

  week 0 - week 12

• Endothelial Progenitor Cells (EPCs)

  hematological parameter, immature bone-marrow derived cells which repair the damaged endothelium, measured by cytofluorimetry

  week 0 - week 12

• Maximum Walking Time

  functional parameter, maximum walking capacity for an individual with IC measured through a treadmill walking test

  week 0 - week 12

• Pain-free Walking Time

  maximum walking capacity for an individual with IC without experiencing pain measured through a treadmill walking test

  week 0 - week 12

• Flow-mediated Dilation

  ultrasonographic evaluation of endothelial function

  week 0 - week 12

Study Arms (3)

Healthy control

NO INTERVENTION

Voluntary subjects without peripheral arterial disease

IC patients, no exercise

SHAM COMPARATOR

Patients with peripheral arterial disease stage II (intermittent claudication) on best medical treatment, given advices to perform regular aerobic activity

Behavioral: sham exercise

IC patients, exercise

ACTIVE COMPARATOR

Patients with peripheral arterial disease stage II (intermittent claudication) on best medical treatment, home-based combined physical exercise

Behavioral: combined aerobic and resistance physical activity

Interventions

combined aerobic and resistance physical activity BEHAVIORAL

Five training sessions weekly for 12 weeks are scheduled. Each session lasts 60 minutes divided into 45 minutes of aerobic workout and 15 minutes of circuit training. The aerobic workout consists of walking on a flat floor or on a slight uphill (maximum slope 3%): patients should walk until submaximal walking capacity (80% of their MWT) and rest as they would experience pain at the lower limbs; afterwards, they should start to walk again, once the pain was improved. Resistance training consists of calisthenics exercises focused on trunk and lower limbs muscles (bicycle, flutter kicks, squats, lunges, calf raises, wall sits and power press) with at least 3 repetitions for each exercise, interspersed by 30 seconds recovery. Duration of repetitions increases every 3 weeks.

IC patients, exercise

sham exercise BEHAVIORAL

general recommendation to perform regular aerobic physical activity

IC patients, no exercise

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• history of stable intermittent claudication (PAD, stage II Fontaine)
• resting ankle-brachial index (ABI) \<0,9 and the presence of occlusion or significant stenosis at the color-Doppler duplex ultrasound scanning

You may not qualify if:

• lower-limb ischemic rest pain or gangrene (Fontaine stages III and IV)
• inability to obtain the ABI value or to perform a walking test
• exercise tolerance limited by factors other than claudication (i.e., arrhythmias, cardiac symptoms or exaggerated blood pressure rise, severe obesity)
• end-stage liver or renal failure
• acute or chronic inflammatory conditions
• history of recent (\<6 months) acute coronary syndrome, cerebrovascular event or inducible myocardial ischemia
• treatment with drugs known to affect walking capacity, including calcium-channel blockers, β-blockers and angiotensin-converting enzyme inhibitors.

Sponsors & Collaborators

• University Of Perugia: lead

Study Sites (1)

Ospedale "Santa Maria della Misericordia" di Perugia

Perugia, PG, 06132, Italy

Location

Related Publications (1)

• Pasqualini L, Bagaglia F, Ministrini S, Frangione MR, Leli C, Siepi D, Lombardini R, Marini E, Naeimi Kararoudi M, Piratinskiy A, Pirro M. Effects of structured home-based exercise training on circulating endothelial progenitor cells and endothelial function in patients with intermittent claudication. Vasc Med. 2021 Dec;26(6):633-640. doi: 10.1177/1358863X211020822. Epub 2021 Jun 21.

  PMID: 34151646 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 5, 2020
• First Posted: March 10, 2020
• Study Start: March 1, 2020
• Primary Completion: December 31, 2020
• Study Completion: January 1, 2021
• Last Updated: March 27, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)