Vasodilation Clinical Trial
Official title:
Evidence of Central and Local Vascular Function Improvements After Chronic Passive Stretching
Verified date | February 2020 |
Source | University of Milan |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 39 |
Est. completion date | February 7, 2020 |
Est. primary completion date | January 7, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion criteria: • None Exclusion criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Italy | Department of Biomedical Science for Health | Milano |
Lead Sponsor | Collaborator |
---|---|
University of Milan |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
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 brachial artery flow mediated dilation at 12 weeks | |
Secondary | Change from baseline in knee range of motion | To monitor the changes in knee range of motion, a bi-axial electrogoniometer was utilized. For the knee joint, the electrogoniometer was placed with one axis on the external condyle of the knee and the other on the external face of the fibula. The knee range of motion was expressed in degrees (deg) | Change from baseline in in Knee Range of Motion at 12 weeks | |
Secondary | Change in knee extensor muscles maximum isometric voluntary contraction | The maximum isometric voluntary contraction of the knee extensor muscles was measured with the participant laying supine on an ergometer with the knee flexed at 90° and firmly secured at the ankle level by a Velcro® strap to a load cell for the force signal detection. Hip and shoulders were also firmly secured to the ergometer. After a warm-up (10 x 2-s contractions at 50% maximum isometric voluntary contraction), three maximum isometric voluntary contraction attempts were performed, interspersed by at least 3 min of recovery. The participants were instructed to push as fast and hard as possible for 3 s. The maximum isometric voluntary contraction (N) was identified as the highest force produced during contraction. | Before, after 6 weeks, at the end (12th week), and after 6 weeks (Follow-up) of PS training |
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