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

Peripheral Arterial Disease Clinical Trial

Official title:

Effects of Home-based Combined Aerobic and Resistance Training on Walking Capacity, Circulating Endothelial Progenitor Cells AND Endothelial Function in Patients With Intermittent Claudication

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04302571
• Other study ID #: APE-IC1
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 1, 2020
• Est. completion date: January 2021

Study information

• Verified date: March 2020
• Source: University Of Perugia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: January 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 80 Years

Eligibility

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, ß-blockers and angiotensin-converting enzyme inhibitors.

Related Conditions & MeSH terms

• Endothelial Dysfunction
• Intermittent Claudication
• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

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.
• sham exercise
general recommendation to perform regular aerobic physical activity

Locations

Country	Name	City	State
Italy	Ospedale "Santa Maria della Misericordia" di Perugia	Perugia	PG

Sponsors (1)

Lead Sponsor	Collaborator
University Of Perugia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endothelial Microparticles (EMPs)	hematological parameter, cells particles released by activated endothelium, measured by cytofluorimetry	week 0 - week 12
Primary	Endothelial Progenitor Cells (EPCs)	hematological parameter, immature bone-marrow derived cells which repair the damaged endothelium, measured by cytofluorimetry	week 0 - week 12
Primary	Maximum Walking Time	functional parameter, maximum walking capacity for an individual with IC measured through a treadmill walking test	week 0 - week 12
Primary	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
Primary	Flow-mediated Dilation	ultrasonographic evaluation of endothelial function	week 0 - week 12