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

NCT ID: NCT04302571

Last Updated: 2020-03-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-01
• Study Completion Date: 2021-01-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Healthy control

Voluntary subjects without peripheral arterial disease

Group Type: NO_INTERVENTION

No interventions assigned to this group

IC patients, no exercise

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

Group Type: SHAM_COMPARATOR

sham exercise

Intervention Type: BEHAVIORAL

general recommendation to perform regular aerobic physical activity

IC patients, exercise

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

Group Type: ACTIVE_COMPARATOR

combined aerobic and resistance physical activity

Intervention Type: 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.

Interventions

combined aerobic and resistance physical activity

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.

Intervention Type: BEHAVIORAL

sham exercise

general recommendation to perform regular aerobic physical activity

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Of Perugia

OTHER

Sponsor Role: lead

Responsible Party

Rita Lombardini

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ospedale "Santa Maria della Misericordia" di Perugia

Perugia, PG, Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 34151646 (View on PubMed)

Other Identifiers

APE-IC1

Identifier Type: -

Identifier Source: org_study_id