Exercise Pressor Reflex and Lifelong Training (LEaSTCaRe)

July 6, 2019 updated by: Massimo Venturelli, PhD, Universita di Verona

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.

Study Overview

Status

Unknown

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

Observational

Enrollment (Anticipated)

48

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Healthy population from different age groups and different exercise training history

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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)
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 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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 1, 2019

Primary Completion (Anticipated)

November 29, 2021

Study Completion (Anticipated)

November 29, 2021

Study Registration Dates

First Submitted

June 21, 2019

First Submitted That Met QC Criteria

July 6, 2019

First Posted (Actual)

July 9, 2019

Study Record Updates

Last Update Posted (Actual)

July 9, 2019

Last Update Submitted That Met QC Criteria

July 6, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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