ClinicalTrials.gg
Status unknownNCT04758754Updated May 29, 2024

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

An interventional study of Training in Aerobic Exercise and Stretching, sponsored by University of Milan. Status unknown at 1 site in Italy. Open to participants aged 20 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-29.

Sponsored by University of Milan · Not applicable, Interventional, and Basic science

The sponsor has not verified this record recently (last verified May 2024), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
20 Years to 30 Years
Sex
All
01

Study 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.

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Conditions studied

  • Aerobic Exercise
  • Stretching
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In context

Lead sponsor

University of Milan is the lead sponsor of 182 studies on the registry; 28 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 30 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

-

Exclusion 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.
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Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
36 participants (estimated)

Study arms

  • 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

  • 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

  • No intervention
    Control (CTRL)

    CTRL will not receive any intervention.

Interventions

  • OtherTraining

    8-weeks iso-volume active (SLKE) or passive static stretching training (PST) involving lower limb muscles

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What researchers measure

Primary outcomes

  1. 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 (%).

    Time frame: Change from baseline in percentage flow mediated dilation at 8 weeks

Secondary outcomes

  1. 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).

    Time frame: Change from baseline in Delta Blood Flow at 8 weeks

07

Study locations

1 of 1 sites recruiting
  • Department of Biomedical Science for Health
    Milan, 20133, Italy
    Recruiting
08

References and documents

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. PubMed 34690287 ↗

Individual participant data

Plan to share: Yes — Statistical Analysis Plan

Supporting information: Study protocol, Statistical analysis plan

Time frame: Data publication up to three years from publication

Access criteria: Mail to Corresponding Author

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Dec 2023 to primary completion in Dec 2023, 0 months.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 8, 2021
First posted
Feb 17, 2021
StartActual
Dec 1, 2023
Primary completionActual
Dec 11, 2023
CompletionEst.
Dec 31, 2024
Last update
May 29, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04758754
Responsible party
Emilano Cè (Associate Professor, University of Milan) — Principal investigator
First posted
Feb 17, 2021
Start date
Dec 1, 2023
Primary completion
Dec 11, 2023
Completion
Dec 31, 2024 (estimated)
Last update
May 29, 2024

Study contacts

Emiliano Cè, PhD
Contact
emiliano.ce@unimi.it
0039 02 50314643
Stefano Longo, PhD
Contact
Stefano.longo@unimi.it
0039 02 50314648

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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