Aerobic ExerciseNCT04758754
Active and Passive Exercise Training in Improving Vascular Function: Local vs Systemic Vascular Effect.
A study testing Training in people with Aerobic Exercise and Stretching, run by University of Milan at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 20 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Aerobic Exercise, Stretching
- What is being tested?
- Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteItaly
- Study dates
- 1 Dec 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- -
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Department of Biomedical Science for Health
Milan, 20133
Emiliano Cè, PhD, (+39) 0250314643, emiliano.ce@unimi.it
Stefano Longo, PhD, (+39) 0250314658, stefano.longo@unimi.it
About this study
Official title: Active and Passive Exercise Training in Improving Vascular Function: Local vs Systemic Vascular Effect
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
- Being tested
- Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrainingOther
8-weeks iso-volume active (SLKE) or passive static stretching training (PST) involving lower limb muscles
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: Training |
| Control (CTRL) | No intervention | CTRL will not receive any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (%).
Measured: Change from baseline in percentage flow mediated dilation at 8 weeks
Secondary outcomes (1)
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).
Measured: Change from baseline in Delta Blood Flow at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2021
- Study start1 Dec 2023
- Primary completion11 Dec 2023
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aerobic ExerciseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three arms: 1) active exercise training (single leg knee extension); 2) passive exercise training (passive static training); 3) controls (no training)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- Collaborators
- Universita di Verona
- Responsible party
- Principal investigator, Emilano Cè, University of Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04758754
- Sponsor's protocol ID
- Active vs passive training
- Status last verified
- May 2024
- First submitted
- 8 Feb 2021
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Statistical Analysis Plan
Publications
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.
PubMed 34690287
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active and Passive Exercise Training in Improving Vascular Function: Local vs Systemic Vascular Effect
- ClinicalTrials.gov ID
- NCT04758754
- Acronym / sponsor ID
- Active vs passive training
- Conditions
- Aerobic Exercise, Stretching
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Collaborators
- Universita di Verona
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 11 Dec 2023 (actual)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 17 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Three arms: 1) active exercise training (single leg knee extension); 2) passive exercise training (passive static training); 3) controls (no training)
| Arm | Type | Receives |
|---|---|---|
| Single leg knee extension training (SLKE) | Experimental | Other: TrainingActive 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. |
| Passive static stretching training (PST) | Active comparator | Other: TrainingPassive 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 |
| Control (CTRL) | No intervention | –CTRL will not receive any intervention. |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Training8-weeks iso-volume active (SLKE) or passive static stretching training (PST) involving lower limb muscles | Other | Passive static stretching training (PST), Single leg knee extension training (SLKE) |
Primary outcome
Change from baseline in brachial artery flow mediated dilation
Time frame: Change from baseline in percentage flow mediated dilation at 8 weeks
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 (%).
1 secondary outcome
Change from baseline in femoral artery delta blood flow
Time frame: Change from baseline in Delta Blood Flow at 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
- Derived from this study: PubMed 34690287Ce 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.
- Individual participant dataSharing planned: Yes. Statistical Analysis Plan
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training in people with Aerobic Exercise and Stretching, run by University of Milan at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emiliano Cè, PhD (0039 02 50314643, emiliano.ce@unimi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in brachial artery flow mediated dilation (time frame: Change from baseline in percentage flow mediated dilation at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04758754, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2024.