- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04013022
Exercise Pressor Reflex and Lifelong Training (LEaSTCaRe)
The Effects of Lifelong Endurance and Strength Training on the Central and Peripheral Cardiovascular Responses
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
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Verona, Italy, 37131
- Recruiting
- University of Verona
-
Contact:
- Massimo Venturelli, PhD
- Email: massimo.venturelli@univr.it
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria
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):
- 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
Exclusion Criteria:
- History of cardiovascular events/diseases
- Respiratory, musculoskeletal, renal, and insulin-resistant diseases
- Hypercholesterolemia
- Use of beta-blockers
- BMI ≥ 30
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Young
Healthy young subjects (age 18 - 30 )
|
The groups will be divided based on their exercise history
|
|
Old Sedentary
Healthy and sedentary old subjects (age 65 - 75)
|
The groups will be divided based on their 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
|
The groups will be divided based on their 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
|
The groups will be divided based on their exercise history
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
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)
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)
|
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
Time Frame: 1 week after recruitment - We will measure the change from baseline to mean value (during stimulation)
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Difference in muscle sympathetic nerve activity between groups to the different stimulations
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1 week after recruitment - We will measure the change from baseline to mean value (during stimulation)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Muscle oxidative capacity in vivo / blood pressure response
Time Frame: 10 days after recruitment - Cross-sectional comparison at one time point only
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Linear regression to check whether an abnormal blood pressure response is explained by the different muscle oxidative capacity measured by NIRS in vivo
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10 days after recruitment - Cross-sectional comparison at one time point only
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General 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.
- Groot 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.
- Boushel 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.
- Murphy 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.
- Markel 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.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 30444
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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