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出境医 / 临床实验 / Exercise Pressor Reflex and Lifelong Training (LEaSTCaRe)

Exercise Pressor Reflex and Lifelong Training (LEaSTCaRe)

Study Description
Brief 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.

Condition or disease Intervention/treatment
Healthy Aging Cardiovascular Risk Factor Behavioral: Exercise History

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
Layout table for study information
Study Type : Observational
Estimated Enrollment : 48 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: The Effects of Lifelong Endurance and Strength Training on the Central and Peripheral Cardiovascular Responses
Estimated Study Start Date : August 1, 2019
Estimated Primary Completion Date : November 29, 2021
Estimated Study Completion Date : November 29, 2021
Arms and Interventions
Group/Cohort Intervention/treatment
Young
Healthy young subjects (age 18 - 30 )
 Behavioral: Exercise History
The groups will be divided based on their exercise history
Old Sedentary
Healthy and sedentary old subjects (age 65 - 75)
 Behavioral: Exercise History
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
 Behavioral: Exercise History
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
 Behavioral: Exercise History
The groups will be divided based on their exercise history
Outcome Measures
Primary Outcome Measures :
  1. 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

  2. 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)

  3. 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


Secondary Outcome Measures :
  1. Muscle oxidative capacity in vivo / blood pressure response [ Time Frame: 10 days after recruitment - Cross-sectional comparison at one time point only ]
    Linear regression to check whether an abnormal blood pressure response is explained by the different muscle oxidative capacity measured by NIRS in vivo


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy population from different age groups and different exercise training history
Criteria

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
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Massimo Venturelli, PhD +39 0458425114 massimo.venturelli@univr.it
Contact: Fabio Giuseppe Laginestra, MSc +39 0458425146 fabiogiuseppe.laginestra@univr.it

Locations
Layout table for location information
Italy
University of Verona Recruiting
Verona, Italy, 37131
Contact: Massimo Venturelli, PhD       massimo.venturelli@univr.it   
Sponsors and Collaborators
Universita di Verona
Investigators
Layout table for investigator information
Principal Investigator: Massimo Venturelli, PhD Universita di Verona
Tracking Information
First Submitted Date June 21, 2019
First Posted Date July 9, 2019
Last Update Posted Date July 9, 2019
Estimated Study Start Date August 1, 2019
Estimated Primary Completion Date November 29, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 6, 2019)
  • 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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: July 6, 2019) 		Muscle oxidative capacity in vivo / blood pressure response [ Time Frame: 10 days after recruitment - Cross-sectional comparison at one time point only ]
Linear regression to check whether an abnormal blood pressure response is explained by the different muscle oxidative capacity measured by NIRS in vivo
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Exercise Pressor Reflex and Lifelong Training
Official Title The Effects of Lifelong Endurance and Strength Training on the Central and Peripheral Cardiovascular Responses
Brief 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.
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 Observational
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Healthy population from different age groups and different exercise training history
Condition
  • Healthy Aging
  • Cardiovascular Risk Factor
Intervention Behavioral: Exercise History
The groups will be divided based on their exercise history
Study Groups/Cohorts
  • Young
    Healthy young subjects (age 18 - 30 )
    Intervention: Behavioral: Exercise History
  • Old Sedentary
    Healthy and sedentary old subjects (age 65 - 75)
    Intervention: 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
    Intervention: 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
    Intervention: Behavioral: Exercise History
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. Review.
  • 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.
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 6, 2019) 		48
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 29, 2021
Estimated Primary Completion Date November 29, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: Male
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Massimo Venturelli, PhD +39 0458425114 massimo.venturelli@univr.it
Contact: Fabio Giuseppe Laginestra, MSc +39 0458425146 fabiogiuseppe.laginestra@univr.it
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT04013022
Other Study ID Numbers 30444
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Massimo Venturelli, PhD, Universita di Verona
Study Sponsor Universita di Verona
Collaborators Not Provided
Investigators
Principal Investigator: Massimo Venturelli, PhD Universita di Verona
PRS Account Universita di Verona
Verification Date July 2019

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