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

NCT04302571 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2020-03-27

No results posted yet for this study

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

Interventions

BEHAVIORAL

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.

BEHAVIORAL

sham exercise

general recommendation to perform regular aerobic physical activity

Sponsors & Collaborators

  • University Of Perugia

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
65 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-03-01
Primary Completion
2020-12-31
Completion
2021-01-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04302571 on ClinicalTrials.gov