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

Primary Purpose

Peripheral Arterial Disease, Endothelial Dysfunction

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
combined aerobic and resistance physical activity
sham exercise
Sponsored by
University Of Perugia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Arterial Disease

Eligibility Criteria

65 Years - 80 Years (Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Ospedale "Santa Maria della Misericordia" di Perugia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Sham Comparator

Active Comparator

Arm Label

Healthy control

IC patients, no exercise

IC patients, exercise

Arm Description

Voluntary subjects without peripheral arterial disease

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

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

Outcomes

Primary Outcome Measures

Endothelial Microparticles (EMPs)
hematological parameter, cells particles released by activated endothelium, measured by cytofluorimetry
Endothelial Progenitor Cells (EPCs)
hematological parameter, immature bone-marrow derived cells which repair the damaged endothelium, measured by cytofluorimetry
Maximum Walking Time
functional parameter, maximum walking capacity for an individual with IC measured through a treadmill walking test
Pain-free Walking Time
maximum walking capacity for an individual with IC without experiencing pain measured through a treadmill walking test
Flow-mediated Dilation
ultrasonographic evaluation of endothelial function

Secondary Outcome Measures

Full Information

First Posted
March 5, 2020
Last Updated
March 25, 2020
Sponsor
University Of Perugia
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1. Study Identification

Unique Protocol Identification Number
NCT04302571
Brief Title
Effects of Combined Aerobic and Resistance Training in Patients With Intermittent Claudication
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
January 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Of Perugia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease, Endothelial Dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy control
Arm Type
No Intervention
Arm Description
Voluntary subjects without peripheral arterial disease
Arm Title
IC patients, no exercise
Arm Type
Sham Comparator
Arm Description
Patients with peripheral arterial disease stage II (intermittent claudication) on best medical treatment, given advices to perform regular aerobic activity
Arm Title
IC patients, exercise
Arm Type
Active Comparator
Arm Description
Patients with peripheral arterial disease stage II (intermittent claudication) on best medical treatment, home-based combined physical exercise
Intervention Type
Behavioral
Intervention Name(s)
combined aerobic and resistance physical activity
Intervention Description
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
Intervention Name(s)
sham exercise
Intervention Description
general recommendation to perform regular aerobic physical activity
Primary Outcome Measure Information:
Title
Endothelial Microparticles (EMPs)
Description
hematological parameter, cells particles released by activated endothelium, measured by cytofluorimetry
Time Frame
week 0 - week 12
Title
Endothelial Progenitor Cells (EPCs)
Description
hematological parameter, immature bone-marrow derived cells which repair the damaged endothelium, measured by cytofluorimetry
Time Frame
week 0 - week 12
Title
Maximum Walking Time
Description
functional parameter, maximum walking capacity for an individual with IC measured through a treadmill walking test
Time Frame
week 0 - week 12
Title
Pain-free Walking Time
Description
maximum walking capacity for an individual with IC without experiencing pain measured through a treadmill walking test
Time Frame
week 0 - week 12
Title
Flow-mediated Dilation
Description
ultrasonographic evaluation of endothelial function
Time Frame
week 0 - week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Ospedale "Santa Maria della Misericordia" di Perugia
City
Perugia
State/Province
PG
ZIP/Postal Code
06132
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34151646
Citation
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.
Results Reference
derived

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

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