Healthy AgingLEaSTCaReNCT04013022
Exercise Pressor Reflex and Lifelong Training
An observational study of Healthy Aging and Cardiovascular Risk Factor, run by Universita di Verona at 1 site in Italy.
Trial summary
Cardiovascular diseases represent the first mortality cause in the world. Ageing is considered as the most prominent risk factor for this kind of diseases. Also, hypertension represents one of the modifiable risk factors. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Aging, Cardiovascular Risk Factor
- What is being tested?
- Exercise History
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 48 participants
- Where
- 1 siteItaly
- Study dates
- 1 Aug 2019to 29 Nov 2021
- Phase
- Observational
- 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 18 to 75 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy population from different age groups and different exercise training history
Who may be able to join
- General:
- Young: 18 - 30, males, non smokers
- Old Sedentary: 65 -75, males, non smokers
- Old Endurance Trained: 65 -75, males, non smokers
- Old Strength Trained: 65 - 75, males, non smokers
- Exercise history (different for each group):
Show all 10Show fewer
- Young: ≤ 5 h/week
- Old Sedentary: ≤ 2h/week
- Old Endurance Trained: ≥ 5 h/week, ≥ 30 years of practice, ≥ 4 sessions/week
- Old Strength Trained: ≥ 5 h/week, ≥ 30 years of practice, ≥ 4 sessions/week
Who cannot join
- History of cardiovascular events/diseases
- Respiratory, musculoskeletal, renal, and insulin-resistant diseases
- Hypercholesterolemia
- Use of beta-blockers
- BMI ≥ 30
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
University of Verona
Verona, 37131
Massimo Venturelli, PhD, massimo.venturelli@univr.it
About this study
Official title: The Effects of Lifelong Endurance and Strength Training on the Central and Peripheral Cardiovascular Responses
Cardiovascular diseases represent the first mortality cause in the world. Ageing is considered as the most prominent risk factor for this kind of diseases. Also, hypertension represents one of the modifiable risk factors. Blood pressure response to exercise is governed by three systems: central command, baroreflex, and a feedback mechanism originating in the skeletal muscle. An abnormal cardiovascular response to exercise facilitates the occurrence of cardiovascular events. The goal of the study is to characterize the cardiovascular response in lifelong trained individuals and explore the potential benefits of endurance and strength training on cardiovascular regulation to exercise onset.
Read the detailed description
Population ageing represents a problem both for health outcomes and for social dynamics in the social welfare states. Currently, the over 60 represents the fastest growing segment of the population. Despite a downward trend in the incidence of cardiovascular diseases, they remain the main culprits for what concern mortality rates in the world. Increasing age is considered the major risk factor for cardiovascular mortality.
One of the main components of the cardiovascular response to exercise is dictated by the exercise pressor reflex originating in the exercising muscle and responding to metabolic and mechanical stimuli. Research indicates that at least 20% of the regulation of blood pressure could be ascribed to these cardiovascular reflexes. A dysfunctional reflex-mediated response increases the chances of cardiovascular events that may end up in severe consequences.
Chronic exercise training is recognized to be an important tool to control blood pressure. The mechanisms through which exercise exerts its effect are multiple. Among these, an improvement of the neural control of the reflex originating in the muscle seems a likely contributor. However, at present, the effect of chronic exercise training on the EPR response in the elderly has not been elucidated. The aim of the study is to characterize the central and peripheral cardiovascular response in the lifelong endurance and strength trained elders population.
- Conditions
- Healthy Aging, Cardiovascular Risk Factor
- Being tested
- Exercise History
- Keywords
- Exercise Pressor Reflex, Metaboreflex, Mechanoreflex, Lifelong exercise training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise HistoryBehavioural
The groups will be divided based on their exercise history
| Study group | Role | What they receive |
|---|---|---|
| Young | Healthy young subjects (age 18 - 30 ) Receives: Behavioral: Exercise History | |
| Old Sedentary | Healthy and sedentary old subjects (age 65 - 75) Receives: Behavioral: Exercise History | |
| Old Endurance Trained | Healthy old subjects ( age 65 - 75) who participated in endurance sports for ≥30 years, ≥5 hours per week and ≥4 sessions per week Receives: Behavioral: Exercise History | |
| Old Strength Trained | Healthy old subjects ( age 65 - 75) who participated in resistance training/sports for ≥30 years, ≥5 hours per week and ≥4 sessions per week Receives: Behavioral: Exercise History |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Arterial Blood Pressure (MAP)
Difference in MAP between groups to post-exercise cuff occlusion
Measured: 1 week after recruitment of the subject - We will measure the changes from baseline to the steady state response ( average of 3rd minute)
Heart Rate (HR)
Difference in heart rate between groups to passive leg movement (PLM)
Measured: 1 week after recruitment of the subject - We will measure the change from baseline to peak (peak response in HR due to PLM)
Muscle Sympathetic Nerve Activity - Microneurography
Difference in muscle sympathetic nerve activity between groups to the different stimulations
Measured: 1 week after recruitment - We will measure the change from baseline to mean value (during stimulation)
Secondary outcomes (1)
Muscle oxidative capacity in vivo / blood pressure response
Linear regression to check whether an abnormal blood pressure response is explained by the different muscle oxidative capacity measured by NIRS in vivo
Measured: 10 days after recruitment - Cross-sectional comparison at one time point only
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2019
- Study start1 Aug 2019 (estimated)
- Primary completion29 Nov 2021 (estimated)
- Study completion29 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Healthy AgingStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universita di Verona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Massimo Venturelli, PhD, Universita di Verona
- Investigators
- Massimo Venturelli, PhD, Principal investigator, Universita di Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04013022
- Sponsor's protocol ID
- 30444
- Acronym
- LEaSTCaRe
- Status last verified
- Jul 2019
- First submitted
- 21 Jun 2019
- Last updated
- 9 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Milia R, Roberto S, Mulliri G, Loi A, Marcelli M, Sainas G, Milia N, Marongiu E, Crisafulli A. Effect of aging on hemodynamic response to metaboreflex activation. Eur J Appl Physiol. 2015 Aug;115(8):1693-703. doi: 10.1007/s00421-015-3153-5. Epub 2015 Mar 24.
PubMed 25802227Groot HJ, Rossman MJ, Garten RS, Wang E, Hoff J, Helgerud J, Richardson RS. The Effect of Physical Activity on Passive Leg Movement-Induced Vasodilation with Age. Med Sci Sports Exerc. 2016 Aug;48(8):1548-57. doi: 10.1249/MSS.0000000000000936.
PubMed 27031748Boushel R. Muscle metaboreflex control of the circulation during exercise. Acta Physiol (Oxf). 2010 Aug;199(4):367-83. doi: 10.1111/j.1748-1716.2010.02133.x. Epub 2010 Mar 27.
PubMed 20353495Murphy MN, Mizuno M, Mitchell JH, Smith SA. Cardiovascular regulation by skeletal muscle reflexes in health and disease. Am J Physiol Heart Circ Physiol. 2011 Oct;301(4):H1191-204. doi: 10.1152/ajpheart.00208.2011. Epub 2011 Aug 12.
PubMed 21841019Markel TA, Daley JC 3rd, Hogeman CS, Herr MD, Khan MH, Gray KS, Kunselman AR, Sinoway LI. Aging and the exercise pressor reflex in humans. Circulation. 2003 Feb 11;107(5):675-8. doi: 10.1161/01.cir.0000055190.81716.ab.
PubMed 12578866
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Lifelong Endurance and Strength Training on the Central and Peripheral Cardiovascular Responses
- ClinicalTrials.gov ID
- NCT04013022
- Acronym / sponsor ID
- LEaSTCaRe / 30444
- Conditions
- Healthy Aging, Cardiovascular Risk Factor
- Keywords
- Exercise Pressor Reflex, Metaboreflex, Mechanoreflex, Lifelong exercise training
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Universita di VeronaUniversity, hospital or other
- Study start
- 1 Aug 2019 (estimated)
- Primary completion
- 29 Nov 2021 (estimated)
- Study completion
- 29 Nov 2021 (estimated)
- First posted
- 9 Jul 2019 (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.
Cardiovascular diseases represent the first mortality cause in the world. Ageing is considered as the most prominent risk factor for this kind of diseases. Also, hypertension represents one of the modifiable risk factors. Blood pressure response to exercise is governed by three systems: central command, baroreflex, and a feedback mechanism originating in the skeletal muscle. An abnormal cardiovascular response to exercise facilitates the occurrence of cardiovascular events. The goal of the study is to characterize the cardiovascular response in lifelong trained individuals and explore the potential benefits of endurance and strength training on cardiovascular regulation to exercise onset.
Detailed description
Population ageing represents a problem both for health outcomes and for social dynamics in the social welfare states. Currently, the over 60 represents the fastest growing segment of the population. Despite a downward trend in the incidence of cardiovascular diseases, they remain the main culprits for what concern mortality rates in the world. Increasing age is considered the major risk factor for cardiovascular mortality.
One of the main components of the cardiovascular response to exercise is dictated by the exercise pressor reflex originating in the exercising muscle and responding to metabolic and mechanical stimuli. Research indicates that at least 20% of the regulation of blood pressure could be ascribed to these cardiovascular reflexes. A dysfunctional reflex-mediated response increases the chances of cardiovascular events that may end up in severe consequences.
Chronic exercise training is recognized to be an important tool to control blood pressure. The mechanisms through which exercise exerts its effect are multiple. Among these, an improvement of the neural control of the reflex originating in the muscle seems a likely contributor. However, at present, the effect of chronic exercise training on the EPR response in the elderly has not been elucidated. The aim of the study is to characterize the central and peripheral cardiovascular response in the lifelong endurance and strength trained elders population.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Young | – | Behavioral: Exercise HistoryHealthy young subjects (age 18 - 30 ) |
| Old Sedentary | – | Behavioral: Exercise HistoryHealthy and sedentary old subjects (age 65 - 75) |
| Old Endurance Trained | – | Behavioral: Exercise HistoryHealthy old subjects ( age 65 - 75) who participated in endurance sports for ≥30 years, ≥5 hours per week and ≥4 sessions per week |
| Old Strength Trained | – | Behavioral: Exercise HistoryHealthy old subjects ( age 65 - 75) who participated in resistance training/sports for ≥30 years, ≥5 hours per week and ≥4 sessions per week |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy population from different age groups and different exercise training history
Key inclusion criteria (10 listed)
- Young: 18 - 30, males, non smokers
- Old Sedentary: 65 -75, males, non smokers
- Old Endurance Trained: 65 -75, males, non smokers
- Old Strength Trained: 65 - 75, males, non smokers
- Young: ≤ 5 h/week
Key exclusion criteria (5 listed)
- History of cardiovascular events/diseases
- Respiratory, musculoskeletal, renal, and insulin-resistant diseases
- Hypercholesterolemia
- Use of beta-blockers
- BMI ≥ 30
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 |
|---|---|---|
| Exercise HistoryThe groups will be divided based on their exercise history | Behavioural | Old Endurance Trained, Old Sedentary, Old Strength Trained, Young |
Primary outcome
Mean Arterial Blood Pressure (MAP)
Time frame: 1 week after recruitment of the subject - We will measure the changes from baseline to the steady state response ( average of 3rd minute)
Difference in MAP between groups to post-exercise cuff occlusion
Heart Rate (HR)
Time frame: 1 week after recruitment of the subject - We will measure the change from baseline to peak (peak response in HR due to PLM)
Difference in heart rate between groups to passive leg movement (PLM)
Muscle Sympathetic Nerve Activity - Microneurography
Time frame: 1 week after recruitment - We will measure the change from baseline to mean value (during stimulation)
Difference in muscle sympathetic nerve activity between groups to the different stimulations
1 secondary outcome
Muscle oxidative capacity in vivo / blood pressure response
Time frame: 10 days after recruitment - Cross-sectional comparison at one time point only
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2019.
- Background: PubMed 25802227Milia R, Roberto S, Mulliri G, Loi A, Marcelli M, Sainas G, Milia N, Marongiu E, Crisafulli A. Effect of aging on hemodynamic response to metaboreflex activation. Eur J Appl Physiol. 2015 Aug;115(8):1693-703. doi: 10.1007/s00421-015-3153-5. Epub 2015 Mar 24.
- Background: PubMed 27031748Groot HJ, Rossman MJ, Garten RS, Wang E, Hoff J, Helgerud J, Richardson RS. The Effect of Physical Activity on Passive Leg Movement-Induced Vasodilation with Age. Med Sci Sports Exerc. 2016 Aug;48(8):1548-57. doi: 10.1249/MSS.0000000000000936.
- Background: PubMed 20353495Boushel R. Muscle metaboreflex control of the circulation during exercise. Acta Physiol (Oxf). 2010 Aug;199(4):367-83. doi: 10.1111/j.1748-1716.2010.02133.x. Epub 2010 Mar 27.
- Background: PubMed 21841019Murphy MN, Mizuno M, Mitchell JH, Smith SA. Cardiovascular regulation by skeletal muscle reflexes in health and disease. Am J Physiol Heart Circ Physiol. 2011 Oct;301(4):H1191-204. doi: 10.1152/ajpheart.00208.2011. Epub 2011 Aug 12.
- Background: PubMed 12578866Markel TA, Daley JC 3rd, Hogeman CS, Herr MD, Khan MH, Gray KS, Kunselman AR, Sinoway LI. Aging and the exercise pressor reflex in humans. Circulation. 2003 Feb 11;107(5):675-8. doi: 10.1161/01.cir.0000055190.81716.ab.
- Individual participant dataSharing planned: No
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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.
Massimo Venturelli, PhD principal investigator
Universita di Verona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Aging and Cardiovascular Risk Factor, run by Universita di Verona 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 10 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 9 Jul 2019. 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 Massimo Venturelli, PhD (+39 0458425114, massimo.venturelli@univr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Arterial Blood Pressure (MAP) (time frame: 1 week after recruitment of the subject - We will measure the changes from baseline to the steady state response ( average of 3rd minute)). The study lists 3 primary outcomes in all. 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 NCT04013022, which also lists 5 linked publications.
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 9 Jul 2019.