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

NCT04758754 | Recruiting

• 1 other identifier: Active vs passive training
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Aerobic Exercise; Stretching

Outcome Measures

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 (%).

  Change from baseline in percentage flow mediated dilation at 8 weeks

Secondary Outcomes (1)

• Change from baseline in femoral artery delta blood flow

  Change from baseline in Delta Blood Flow at 8 weeks

Study Arms (3)

Single leg knee extension training (SLKE)

EXPERIMENTAL

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

Passive static stretching training (PST)

ACTIVE COMPARATOR

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

Control (CTRL)

NO INTERVENTION

CTRL will not receive any intervention.

Interventions

Training OTHER

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

Passive static stretching training (PST); Single leg knee extension training (SLKE)

Eligibility Criteria

• Age: 20 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Milan: lead
• Universita di Verona: collaborator

Study Sites (1)

Department of Biomedical Science for Health

Milan, 20133, Italy

RECRUITING

Related Publications (1)

• 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.

  PMID: 34690287 DERIVED

Central Study Contacts

Emiliano Cè, PhD

CONTACT

0039 02 50314643; emiliano.ce@unimi.it

Stefano Longo, PhD

CONTACT

0039 02 50314648; Stefano.longo@unimi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blind to intervention
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Three arms: 1) active exercise training (single leg knee extension); 2) passive exercise training (passive static training); 3) controls (no training)

Study Record Dates

• First Submitted: February 8, 2021
• First Posted: February 17, 2021
• Study Start: December 1, 2023
• Primary Completion: December 11, 2023
• Study Completion: December 31, 2024
• Last Updated: May 29, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data publication up to three years from publication
• Access Criteria: Mail to Corresponding Author

Locations

IT (1)