NCT05053282

Brief Summary

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:
  • 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.
  • 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2020

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 3, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 22, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

September 22, 2021

Status Verified

September 1, 2021

Enrollment Period

1.8 years

First QC Date

August 3, 2021

Last Update Submit

September 13, 2021

Conditions

Keywords

agingexerciseendurance runningcircadianinflammationbone density

Outcome Measures

Primary Outcomes (1)

  • maximal oxygen consumption

    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 Outcomes (8)

  • body composition

    cross-sectional, one-point assessment over 1 day

  • bone mineral content

    cross-sectional, one-point assessment over 1 day

  • bone mineral density

    cross-sectional, one-point assessment over 1 day

  • maximum isometric muscle strength

    cross-sectional, one-point assessment over 1 day

  • maximum isometric muscle torque development

    cross-sectional, one-point assessment over 1 day

  • +3 more secondary outcomes

Other Outcomes (9)

  • skeletal muscle tissue - (PCR) RNA expression

    cross-sectional, one-point assessment over 1 day

  • biochemical biomarkers of nitrogen compounds

    cross-sectional, one-point assessment over 1 day

  • biochemical biomarkers of lipid and carbohydrate metabolism

    cross-sectional, one-point assessment over 1 day

  • +6 more other outcomes

Study Arms (4)

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

Other: endurance running exercise

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

Other: endurance running exercise

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

Interventions

regular competitive or non-competitive running of medium and/or high intensity with the duration at least 20 minutes per session

master endurance athletesyoung endurance athletes

Eligibility Criteria

Age20 Years - 75 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Comenius University in Bratislava, Faculty of physical education and sport Bratislava, Slovakia

Bratislava, 814 99, Slovakia

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

whole blood white cells blood serum and plasma skeletal muscle tissue from m. vastus medialis saliva

MeSH Terms

Conditions

Motor ActivityInflammation

Condition Hierarchy (Ancestors)

BehaviorPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ján Cvečka, PhD.

    Comenius University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Milan Sedliak, assoc. prof.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2021

First Posted

September 22, 2021

Study Start

September 1, 2020

Primary Completion

June 30, 2022

Study Completion

September 30, 2022

Last Updated

September 22, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations