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Clinical Trials/NCT04758754
NCT04758754
Recruiting
Not Applicable

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

University of Milan1 site in 1 country36 target enrollmentDecember 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Aerobic Exercise
Sponsor
University of Milan
Enrollment
36
Locations
1
Primary Endpoint
Change from baseline in brachial artery flow mediated dilation
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 1, 2023
End Date
December 31, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Emilano Cè

Associate Professor

University of Milan

Eligibility Criteria

Inclusion Criteria

  • Not provided

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.

Outcomes

Primary Outcomes

Change from baseline in brachial artery flow mediated dilation

Time Frame: 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 Outcomes

  • Change from baseline in femoral artery delta blood flow(Change from baseline in Delta Blood Flow at 8 weeks)

Study Sites (1)

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