Vascular Function Improvements After Chronic Passive Stretching

NCT04271241 | Completed DMC

• 1 other identifier: Stretching vasomotor response
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

Acutely, during different bouts of passive stretching (PS), blood flow (Q ̇) and shear rate ( ) in the feeding artery of the stretched muscles increases during the first two elongations and then it reduces during the following bouts. This hyperemic response during the first two elongations is mediated by the local release of vasoactive molecules (e.g. nitric oxide, NO). This phenomenon disappears during the following elongations due to the NO and other vasoactive molecule depletion. The relaxation phase between stretching bouts, instead, is always characterized by hyperemia as results of stretch-induced peripheral resistances decrease. Whether chronic PS administration may influence vascular function is still a matter of investigation. The hypothesis is that repetitive PS-induced Q ̇ and changes may be an enough stimulus to provoke increments in NO bioavailability, thus improving vasomotor response.

Conditions

Vasodilation; Vasoconstriction; Stretch; Sympathetic; Imbalance

Keywords

Chronic passive stretching; Central and peripheral arterial stiffness; Blood pressure; Vasomotor response; Crossover effect

Outcome Measures

Primary Outcomes (3)

• Change from baseline in augmentation Index

  The radial artery pressure wave and amplitude were recorded non-invasively by means of applanation tonometry of the radial artery. Twenty sequential waveforms covering a complete respiratory cycle were acquired from the system and used by the software to generate an average peripheral and corresponding central waveform. The systolic part of the wave form was characterized by two pressure peaks of the central waveform. The first peak results from the left cardiac ventricle ejection while the second one results from the wave reflections from the periphery. The difference between these two peaks represents the degree of the central arterial pressure augmentation due to wave reflection (i.e., the augmentation index, mmHg)

  Change from baseline in Augmentation Index at 12 weeks

• 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 12 weeks

• 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 brachial artery flow mediated dilation at 12 weeks

Secondary Outcomes (2)

• Change from baseline in knee range of motion

  Change from baseline in in Knee Range of Motion at 12 weeks

• Change in knee extensor muscles maximum isometric voluntary contraction

  Before, after 6 weeks, at the end (12th week), and after 6 weeks (Follow-up) of PS training

Study Arms (4)

Control (Ctrl)

NO INTERVENTION

Ctrl group di not undergo any training

PS bilateral limbs (PSBil)

EXPERIMENTAL

PSBil underwent 12 weeks of passive stretching on both the lower limbs

Other: Passive stretching (PS) training

PS monolateral limb, stretched limb (PSMonoSL)

EXPERIMENTAL

PSMonoSL underwent 12 weeks of passive stretching on just one lower limb (SL). Outcomes form this group were obtained from the stretched

Other: Passive stretching (PS) training

PS monolateral limb, contralateral limb PSMonoCL

EXPERIMENTAL

PSMonoCL involved the same participants as in PSMonoSL. Outcomes form this group were obtained from the contralateral not stretched limb (CL). Data from this limb helped in identify possible PS-induced crossover effects in the vasomotor response.

Other: Passive stretching (PS) training

Interventions

Passive stretching (PS) training OTHER

PSBil and PSMono underwent 12 weeks of PS training, 3 sessions per week (36 sessions in total). In PSBil, each session lasted 40 min and included two maneuvers for both the knee extensor and plantar flexor muscles with the following protocol: 45 s elongation and 15 s recovery in the resting position, all the cycle repeated for five times 7. In PSMono, exercises were performed only on the right limb and each session had a duration of 20 min. Ctrl did not underwent any PS exercise throughout the study. To promote participants' compliance, daily classes were held at different day time (morning and afternoon) at the University Sports Centre gym. Each class was supervised by an expert operator, which monitored the attendance, the correct exercise execution and the intensity exerted during the exercise (80% of the point of discomfort). The participants not attending at least the 80% of classes were excluded from the study, and a new participant was recruited to substitute the drop out.

PS bilateral limbs (PSBil); PS monolateral limb, contralateral limb PSMonoCL; PS monolateral limb, stretched limb (PSMonoSL)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• None

You may not qualify if:

• presence of neurological, vascular and musculoskeletal impairments at the lower and upper limbs level;
• 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 three months before the beginning of the study,
• presenting contraindication for joint mobilization;
• being regularly involved in PS program.

Sponsors & Collaborators

• University of Milan: lead

Study Sites (1)

Department of Biomedical Science for Health

Milan, 20133, Italy

Location

MeSH Terms

Conditions

Aneurysm

Interventions

Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Emiliano Cè, PhD

  University of Milan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessor are in-blind about the participants' allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Four groups in parallel (three intervention groups and one control) tested at the beginning, during, after and after six weeks (follow-up) from intervention

Study Record Dates

• First Submitted: February 10, 2020
• First Posted: February 17, 2020
• Study Start: January 7, 2019
• Primary Completion: January 7, 2020
• Study Completion: February 7, 2020
• Last Updated: February 17, 2020

Record last verified: 2020-02

Locations

IT (1)