Long-life Endurance Exercise and Healthy Aging (CAA)

September 13, 2021 updated by: Comenius University

Active Aging: Effect of Life-long Endurance Exercises on the Circadian Regulation of Physiological Processes and Their Maintenance in Aging

The project aims to explore the mechanisms by which lifelong exercise can promote healthy aging and slow down the negative impact of aging on the muscular system, immunity and the circadian system. The main goal of the project is to investigate the effect of lifelong endurance exercise on physical fitness, body composition, bone density and selected hormonal, biochemical, histological and molecular indicators of metabolic health and circadian clock function based on blood, immune cell and skeletal muscle tissue analyses in volunteers differentiated by age and weekly volume of physical activity.

It is hypothesized that lifelong endurance exercise may have beneficial effects on the circadian system stability and many, but not all health outcomes. Osteopenia/osteoporosis and low-grade malnutrition may be more prevalent in the group of endurance-trained senior runners.

In order to achieve the above research aims, sixty male subjects in total will be recruited according to inclusion and exclusion criteria. Four groups of subjects will differ according to their age and physical activity levels:

  • a group of endurance-trained seniors (age range 65 - 75 year old, n=15) ● a group of sedentary seniors (age range 65 - 75 year old, n=15)
  • a group of well endurance-trained young men (age range 20 - 30 year old, n=15) ● a group of sedentary young men (age range 20 - 30 year old, n=15).

Subjects must meet the following inclusion criteria:

  1. for athletes' groups: defined as more than 150 minutes of running activity per week; for young athletes at least 3 years and for master athletes at least 15 years history of running.
  2. for groups less active than recommended: no history of regular physical activity training and no more practice than 150 minutes of moderate or 75 minutes of vigorous intensity per week.

The standard inclusion criterion for every group will be body mass index (range 18.5-30 kg/m2).

No experimental study has been published on the potential of life-long exercise to attenuate the aging-induced disorganization of the circadian system and thus to promote healthy aging. In this aspect, the proposed study is original and up-to-date. Moreover, also other aspects of the study, e.g. exercise and inflammaging or the risks (besides the benefits) of the long-life endurance training on bone tissue etc. have been studied only scarcely. Therefore, more scientific information is needed before it can be safely prescribed to the aging population

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

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

Study Contact

Study Locations

      • Bratislava, Slovakia, 814 99
        • Recruiting
        • Comenius University in Bratislava, Faculty of physical education and sport Bratislava, Slovakia
        • Contact:

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

16 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Inhabitants of Bratislava city (Slovakia) and those living within one hour drive by car from the laboratory (Faculty of Physical Education and Sport, Comenius University in Bratislava)

Description

Inclusion Criteria:

for athletes' groups (master - 65 - 75 years old, and young athletes - 20 - 30 years old)

  • more than 150 minutes of running activity which is by ACSM considered as vigorous intensity of endurance running for young athletes at least 3 years and for master athletes at least 15 years
  • body mass index (BMI index) - range 18.5-30 kg/m2

for groups less active than recommended (sedentary young and elderly)

  • no history of regular physical activity training and no more practice than 150 minutes of moderate or 75 minutes of vigorous intensity per week
  • body mass index (BMI index) - range 18.5-30 kg/m2

Exclusion Criteria

  • recent or current infection
  • malignant disease
  • uncontrolled hypertension (higher than 160 / 95mmHG)
  • congestive heart failure (NYHA grade III and IV)
  • unstable angina pectoris
  • recent myocardial infarction (during the last 6 months)
  • severe cardiac arrhythmia (anamnestic)
  • chronic obstructive pulmonary disease
  • presence of severe pulmonary, pleural or pericardial disease
  • severe asthma
  • recent sudden stroke (during the last 6 months)
  • epilepsy
  • insulin-dependent diabetes mellitus
  • unstable bone lesions with a high risk of fractures
  • other chronic diseases, at the discretion of the responsible doctor
  • states of mental incompetence (severe anxiety and depression, dementia, alcoholism , or other dependencies, mental retardation)
  • conditions complicating regular physical activity (uncontrollable pain, severe arthritis, planned knee / hip endoprosthesis, pathological fractures (last 6 months), amputation, use of walker, wheelchair
  • pharmacological interference (e.g., steroids, nonsteroidal anti-inflammatory agents, immunosuppressive and antineoplastic drugs, beta blockers, statins)
  • the use of performance-enhancing drugs in the past and during the study period

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: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
master endurance athletes
men aged 65 to 75 with more than 150 minutes of running activity per week at least 15 years history of running
regular competitive or non-competitive running of medium and/or high intensity with the duration at least 20 minutes per session
elderly sedentary
men aged 65 to 75 with no history of regular physical activity training and no more practice than 150 minutes of moderate or 75 minutes of vigorous intensity per week according the ACSM recommendations
young endurance athletes
men aged 20 to 30 with more than 150 minutes of running activity per week at least 3 years history of running
regular competitive or non-competitive running of medium and/or high intensity with the duration at least 20 minutes per session
young sedentary
men aged 20 to 30 with no history of regular physical activity training and no more practice than 150 minutes of moderate or 75 minutes of vigorous intensity per week according the ACSM recommendations

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
maximal oxygen consumption
Time Frame: cross-sectional, one-point assessment over 1 day
peak oxygen consumption normalised to body mass (mL/kg/min), measured through a graded cycling ergometry
cross-sectional, one-point assessment over 1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
body composition
Time Frame: cross-sectional, one-point assessment over 1 day
DXA method - fat mass (grams), lean mass (grams) and total mass (grams)
cross-sectional, one-point assessment over 1 day
bone mineral content
Time Frame: cross-sectional, one-point assessment over 1 day
DXA method - BMC (grams)
cross-sectional, one-point assessment over 1 day
bone mineral density
Time Frame: cross-sectional, one-point assessment over 1 day
DXA method - BMD (g/cm2)
cross-sectional, one-point assessment over 1 day
maximum isometric muscle strength
Time Frame: cross-sectional, one-point assessment over 1 day
maximum voluntary contraction (Nm) of both isometric extension and flexion on knee dynamometer
cross-sectional, one-point assessment over 1 day
maximum isometric muscle torque development
Time Frame: cross-sectional, one-point assessment over 1 day
rate of torque development (Nm/s) of both isometric extension and flexion on knee dynamometer
cross-sectional, one-point assessment over 1 day
Immunohistochemical analyses - skeletal muscle cell morphometry
Time Frame: cross-sectional, one-point assessment over 1 day
cross-sectional area (um2) of myosin heavy chain I (BA-D5) positive fibers
cross-sectional, one-point assessment over 1 day
Immunohistochemical analyses - skeletal muscle tissue morphology
Time Frame: cross-sectional, one-point assessment over 1 day
number of myonuclei, satellite cells, capillaries - counted per each fiber type nuclear number per fiber
cross-sectional, one-point assessment over 1 day
circadian system phase
Time Frame: cross-sectional, two-point assessment at morning and afternoon over 1 day
CD14-positive monocytes (mRNA levels of selected clock and clock-controlled genes /alternatively microarray analysis in sub-sample of subjects from each group) blood count
cross-sectional, two-point assessment at morning and afternoon over 1 day

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
skeletal muscle tissue - (PCR) RNA expression
Time Frame: cross-sectional, one-point assessment over 1 day
Target genes for inflammatory markers
cross-sectional, one-point assessment over 1 day
biochemical biomarkers of nitrogen compounds
Time Frame: cross-sectional, one-point assessment over 1 day
creatinine (umol/L), total bilirubin (umol/L),uric acid(umol/L)
cross-sectional, one-point assessment over 1 day
biochemical biomarkers of lipid and carbohydrate metabolism
Time Frame: cross-sectional, one-point assessment over 1 day
serum glucose (mmol/L), total cholesterol urea (mmol/L), low-density lipoprotein cholesterol urea (mmol/L), high-density lipoprotein cholesterol urea (mmol/L), triacylglycerols (mmol/L)
cross-sectional, one-point assessment over 1 day
biochemical malnutrition biomarkers
Time Frame: cross-sectional, one-point assessment over 1 day
transthyretin, retinol binding protein(μg/mL)
cross-sectional, one-point assessment over 1 day
biochemical liver function biomarkers
Time Frame: cross-sectional, one-point assessment over 1 day
aspartate aminotransferase (ukat/L), alanine aminotransferase (ukat/L), γ-glutamyltransferase (ukat/L)
cross-sectional, one-point assessment over 1 day
dietary macronutirents intake tracking
Time Frame: cross-sectional, one-point assessment over seven consecutive days
Macronutrients (carbohydrate, fat, and protein in grams) data will be retrieved from each participant's diary and expressed as a daily average for total intakes.
cross-sectional, one-point assessment over seven consecutive days
dietary energy intake tracking
Time Frame: cross-sectional, one-point assessment over seven consecutive days
Energy (kilocalorie) data will be retrieved from each participant's diary and expressed as a daily average for total and relative intakes.
cross-sectional, one-point assessment over seven consecutive days
physical activity monitoring
Time Frame: cross-sectional, one-point assessment over seven consecutive days
ActivPAL device - static and dynamic acceleration to distinguish body posture as sitting/lying, standing, and stepping and estimate energy expenditure expressed as metabolic equivalents - MET
cross-sectional, one-point assessment over seven consecutive days
chronotype
Time Frame: cross-sectional, one-point assessment over 1 day
score in The Munich ChronoType Questionnaire (MCTQ), total scores can range from 16 to 86, with the lowest values representing extreme-late chronotypes.
cross-sectional, one-point assessment over 1 day

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Ján Cvečka, PhD., Comenius University

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 (Actual)

September 1, 2020

Primary Completion (Anticipated)

June 30, 2022

Study Completion (Anticipated)

September 30, 2022

Study Registration Dates

First Submitted

August 3, 2021

First Submitted That Met QC Criteria

September 13, 2021

First Posted (Actual)

September 22, 2021

Study Record Updates

Last Update Posted (Actual)

September 22, 2021

Last Update Submitted That Met QC Criteria

September 13, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 305041X157

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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