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

Aerobic Exercise Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04758754
• Other study ID #: Active vs passive training
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: November 30, 2022

Study information

• Verified date: May 2022
• Source: University of Milan
• Contact: Emiliano Cè, PhD
• Phone: 0039 02 50314643
• Email: emiliano.ce[@]unimi.it
• Is FDA regulated: No
• 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: November 30, 2022
• Est. primary completion date: October 31, 2022
• 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.

Related Conditions & MeSH terms

• Aerobic Exercise
• Stretching

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