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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04013022
Other study ID # 30444
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 1, 2019
Est. completion date November 29, 2021

Study information

Verified date July 2019
Source Universita di Verona
Contact Massimo Venturelli, PhD
Phone +39 0458425114
Email massimo.venturelli@univr.it
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 48
Est. completion date November 29, 2021
Est. primary completion date November 29, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 75 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Exercise History
The groups will be divided based on their exercise history

Locations

Country Name City State
Italy University of Verona Verona

Sponsors (1)

Lead Sponsor Collaborator
Universita di Verona

Country where clinical trial is conducted

Italy, 

References & Publications (5)

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Mean Arterial Blood Pressure (MAP) 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)
Primary Heart Rate (HR) 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)
Primary Muscle Sympathetic Nerve Activity - Microneurography Difference in muscle sympathetic nerve activity between groups to the different stimulations 1 week after recruitment - We will measure the change from baseline to mean value (during stimulation)
Secondary 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 10 days after recruitment - Cross-sectional comparison at one time point only
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