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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04758754
Other study ID # Active vs passive training
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 1, 2023
Est. completion date December 31, 2024

Study information

Verified date May 2024
Source University of Milan
Contact Emiliano Cè, PhD
Phone 0039 02 50314643
Email emiliano.ce@unimi.it
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 36
Est. completion date December 31, 2024
Est. primary completion date December 11, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 30 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Italy Department of Biomedical Science for Health Milano

Sponsors (2)

Lead Sponsor Collaborator
University of Milan Universita di Verona

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
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