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

Sponsor
University of Milan (Other)
Overall Status
Recruiting
CT.gov ID
NCT04758754
Collaborator
Universita di Verona (Other)
36
1
3
7
5.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Training
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
36 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Three arms: 1) active exercise training (single leg knee extension); 2) passive exercise training (passive static training); 3) controls (no training)Three arms: 1) active exercise training (single leg knee extension); 2) passive exercise training (passive static training); 3) controls (no training)
Masking:
Single (Outcomes Assessor)
Masking Description:
Blind to intervention
Primary Purpose:
Basic Science
Official Title:
Active and Passive Exercise Training in Improving Vascular Function: Local vs Systemic Vascular Effect
Actual Study Start Date :
May 1, 2022
Anticipated Primary Completion Date :
Oct 31, 2022
Anticipated Study Completion Date :
Nov 30, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Change from baseline in brachial artery flow mediated dilation [Change from baseline in percentage flow mediated dilation at 8 weeks]

    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 (%).

Secondary Outcome Measures

  1. Change from baseline in femoral artery delta blood flow [Change from baseline in Delta Blood Flow at 8 weeks]

    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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 30 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Biomedical Science for Health Milano Italy 20133

Sponsors and Collaborators

  • University of Milan
  • Universita di Verona

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Emilano Cè, Associate Professor, University of Milan
ClinicalTrials.gov Identifier:
NCT04758754
Other Study ID Numbers:
  • Active vs passive training
First Posted:
Feb 17, 2021
Last Update Posted:
May 17, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of May 17, 2022