Long-life Endurance Exercise and Healthy Aging

Aging Clinical Trial

— CAA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05053282
• Other study ID #: 305041X157
• Status: Recruiting
• Start date: September 1, 2020
• Est. completion date: September 30, 2022

Study information

• Verified date: September 2021
• Source: Comenius University
• Contact: Milan Sedliak, assoc. prof.
• Phone: +421907247021
• Email: milan.sedliak[@]uniba.sk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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: 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Aging

Intervention

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

Locations

Country	Name	City	State
Slovakia	Comenius University in Bratislava, Faculty of physical education and sport Bratislava, Slovakia	Bratislava

Sponsors (5)

Lead Sponsor	Collaborator
Comenius University	Physiko- und Rheumatherapie Gesellschaft m.b.H., University of Padova, University of Primorska, University of Roma La Sapienza

Country where clinical trial is conducted

Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	skeletal muscle tissue - (PCR) RNA expression	Target genes for inflammatory markers	cross-sectional, one-point assessment over 1 day
Other	biochemical biomarkers of nitrogen compounds	creatinine (umol/L), total bilirubin (umol/L),uric acid(umol/L)	cross-sectional, one-point assessment over 1 day
Other	biochemical biomarkers of lipid and carbohydrate metabolism	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
Other	biochemical malnutrition biomarkers	transthyretin, retinol binding protein(µg/mL)	cross-sectional, one-point assessment over 1 day
Other	biochemical liver function biomarkers	aspartate aminotransferase (ukat/L), alanine aminotransferase (ukat/L), ?-glutamyltransferase (ukat/L)	cross-sectional, one-point assessment over 1 day
Other	dietary macronutirents intake tracking	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
Other	dietary energy intake tracking	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
Other	physical activity monitoring	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
Other	chronotype	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
Primary	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	body composition	DXA method - fat mass (grams), lean mass (grams) and total mass (grams)	cross-sectional, one-point assessment over 1 day
Secondary	bone mineral content	DXA method - BMC (grams)	cross-sectional, one-point assessment over 1 day
Secondary	bone mineral density	DXA method - BMD (g/cm2)	cross-sectional, one-point assessment over 1 day
Secondary	maximum isometric muscle strength	maximum voluntary contraction (Nm) of both isometric extension and flexion on knee dynamometer	cross-sectional, one-point assessment over 1 day
Secondary	maximum isometric muscle torque development	rate of torque development (Nm/s) of both isometric extension and flexion on knee dynamometer	cross-sectional, one-point assessment over 1 day
Secondary	Immunohistochemical analyses - skeletal muscle cell morphometry	cross-sectional area (um2) of myosin heavy chain I (BA-D5) positive fibers	cross-sectional, one-point assessment over 1 day
Secondary	Immunohistochemical analyses - skeletal muscle tissue morphology	number of myonuclei, satellite cells, capillaries - counted per each fiber type nuclear number per fiber	cross-sectional, one-point assessment over 1 day
Secondary	circadian system phase	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