Active and Passive Exercise Training in Improving Vascular Function: Local vs Systemic Vascular Effect.

Active and Passive Exercise Training in Improving Vascular Function: Local vs Systemic Vascular Effect

Maintaining an adequate state of vascular function is an important element for the maintenance of cardiovascular well-being. Several training plans involving both active and passive engagement by the muscles have been proposed with the aim of improving vascular function. At local level, i.e., at the level of the arteries that supply the muscles directly involved in training, significant improvements in vascular function have been found. These improvements are more noticeable after active training than with a passive training regimen, such as passive static stretching. On the contrary, at the systemic level the effects of active or passive training are less clear and, above all, it is not evident whether there is a difference in the effects induced at the level of vascular function in arteries supplying muscles not directly involved in training. The aim of the study is to clarify the local and systemic effect of an active training protocol (single leg knee extension, SLKE) and of a passive training protocol (passive static stretching training, PST) applied to the lower limbs lasting 8 weeks on the local (femoral artery) and systemic (brachial artery) vascular function.

Study Overview

• Status: Recruiting
• Conditions: Aerobic Exercise; Stretching
• Intervention / Treatment: Other: Training

• Study Type: Interventional
• Enrollment (Anticipated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emiliano Cè, PhD; Phone Number: 0039 02 50314643; Email: emiliano.ce@unimi.it
• Study Contact Backup: Name: Stefano Longo, PhD; Phone Number: 0039 02 50314648; Email: Stefano.longo@unimi.it

Study Locations

• Italy
  • Milano, Italy, 20133
    • Recruiting
    • Department of Biomedical Science for Health
    • Contact: Emiliano Cè, PhD; Phone Number: (+39) 0250314643; Email: emiliano.ce@unimi.it
    • Contact: Stefano Longo, PhD; Phone Number: (+39) 0250314658; Email: stefano.longo@unimi.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 30 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

-

Exclusion Criteria:

• neurological, vascular and musculoskeletal disorders of the lower and upper limbs;
• being on pharmacological therapy related to either neural and/or vascular response, including hormonal contraceptives and oral supplements;
• being a current or former smoker;
• having an irregular menstrual cycle (26 to 35 days) up to 3 months before the beginning of the study;
• contraindications to joint mobilization; regular involvement in a SLKE or PS training programme.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single leg knee extension training (SLKE); Active 8-week training involving lower limbs. SLKE participants will be involved in a 8-week aerobic training protocol involving the knee extensor muscles. The training will be held on an Anderson and Saltin ergometer, 3 times per week, with a single session duration of 33.3 min. Total weekly duration: 100 min.	Other: Training; 8-weeks iso-volume active (SLKE) or passive static stretching training (PST) involving lower limb muscles
Active Comparator: Passive static stretching training (PST); Passive 8-week training involving lower limbs. PST participants will be involved in a 8-week passive static training training involving the knee extensor muscles. The training will have a frequency of 5 times per week, with a single duration of 20 min. Total weekly duration: 100 min	Other: Training; 8-weeks iso-volume active (SLKE) or passive static stretching training (PST) involving lower limb muscles
No Intervention: Control (CTRL); CTRL will not receive any intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in brachial artery flow mediated dilation	Flow mediated dilation was performed at brachial artery level. An arterial pressure cuff was placed around the forearm immediately distal to the olecranon process to provide an ischemic stimulus when inflated. Following baseline assessment, the blood pressure cuff was inflated to 250 mmHg. Artery diameter was and blood flow were resumed at baseline, 30 s prior to cuff deflation and continued for 2 min post-deflation by a linear array transducer attached to a high-resolution ultrasound machine. When an optimal image was obtained, the probe was held stable and longitudinal in B-mode, acquiring images of the lumen-arterial wall interface. Continuous Doppler velocity assessments were also obtained and collected using the lowest possible insonation angle (<60°). Data were exported and analyzed using commercially available software. Flow mediated dilation was quantified as the maximal change in artery diameter after cuff release, expressed as a percentage increase above baseline (%).	Change from baseline in percentage flow mediated dilation at 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in femoral artery delta blood flow	Femoral artery blood flow was calculated by Doppler ultrasound at baseline and at peak after single passive knee flexion and extension by using the femoral artery diameter and mean blood velocity. The difference between baseline and at peak blood flow identifies the Delta Blood Flow (ml/min).	Change from baseline in Delta Blood Flow at 8 weeks

Collaborators and Investigators

• Sponsor: University of Milan
• Collaborators: Universita di Verona

Publications and helpful links

General Publications

• Ce E, Venturelli M, Bisconti AV, Longo S, Pedrinolla A, Coratella G, Schena F, Esposito F. Long-Term Passive Leg Stretch Improves Systemic Vascular Responsiveness as Much as Single-Leg Exercise Training. Med Sci Sports Exerc. 2022 Mar 1;54(3):475-488. doi: 10.1249/MSS.0000000000002811.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Anticipated): October 31, 2022
• Study Completion (Anticipated): November 30, 2022

Study Registration Dates

• First Submitted: February 8, 2021
• First Submitted That Met QC Criteria: February 12, 2021
• First Posted (Actual): February 17, 2021

Study Record Updates

• Last Update Posted (Actual): May 17, 2022
• Last Update Submitted That Met QC Criteria: May 16, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: Active vs passive training

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Statistical Analysis Plan
• IPD Sharing Time Frame: Data publication up to three years from publication
• IPD Sharing Access Criteria: Mail to Corresponding Author
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No