Multi-level Molecular Profiling of Peak Performance in Endurance Sports

NCT ID: NCT05359744

Last Updated: 2022-05-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-15
• Study Completion Date: 2022-10-15

Brief Summary

Physical activity triggers complex molecular responses, including changes in immune-, stress-, and metabolic pathways. For example, autophagy is essential for energy and cellular homeostasis through protein catabolism, and dysregulation results in compromised proteostasis, reduced exercise performance, and excessive secretion of signaling molecules and inflammatory proteins. However, previous research has been limited by the extend of molecules measured and biological processes covered. A better understanding of these processes through multi-omic analysis can improve knowledge of molecular changes in response to exercise. The main purpose of the investigators study is to analyze the effects of acute exercise in correlation to autophagy and other signaling cascades. Specifically, the investigators plan to perform multi-level molecular profiling in a cohort of healthy male elite cyclists and male and female recreational athletes, before, during, and after a bicycle ergometer test. The results will be compared to a control cohort without intervention.

Detailed Description

This is a non-randomized controlled trial performed at the Paracelsus Medical University, Salzburg, Austria. The study will recruit 80 healthy men and women. Subjects who meet the inclusion criteria will be allocated to four arms (n = 20 in all groups): 1. elite cyclists, 2. male recreational athletes, 3. female recreational athletes, 4. male control group.

After overnight fasting and medical check-up, groups 1-3 will undergo a bicycle ergometer-based exercise protocol designed to span low (aerobic) to severe (anaerobic) domains of exercise. The protocol consists of a 15 min aerobic warm-up phase followed by a ramp-bicycle ergometer protocol.

During exercise, performance-relevant data will be continuously monitored. Venous blood specimens will be collected before exercise (baseline), at the end of the warm-up as well as 2 min, 10 min, and 30 min in recovery.

Conditions

Exercise; Exercise Test; Physical Fitness; Healthy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Elite cyclists, male

Bicycle ergometer-based exercise testing. 15 min aerobic warm-up phase (2 W/kg) followed by a standardized but individualized ramp-bicycle ergometer protocol to reach maximal exercise capacity after 8 - 12 minutes. The exclusively aerobic energy supply during warm-up will be assessed by constant respiratory quotient and constant arterial lactate concentration (\<0.5 mmol in the last 5 min). During exercise, respiratory gas exchange, heart rate, blood pressure, ECG and ratings of perceived exertion will be continuously monitored. Venous blood specimens will be collected before exercise (baseline), at the end of the warm-up as well as 2 min, 10 min, and 30 min in recovery.

Group Type: EXPERIMENTAL

Performance testing

Intervention Type: DIAGNOSTIC_TEST

Performance testing on a bicycle ergometer.

Recreational athletes, male

Bicycle ergometer-based exercise testing. 15 min aerobic warm-up phase (1 W/kg) followed by a standardized but individualized ramp-bicycle ergometer protocol to reach maximal exercise capacity after 8 - 12 minutes. The exclusively aerobic energy supply during warm-up will be assessed by constant respiratory quotient and constant arterial lactate concentration (\<0.5 mmol in the last 5 min). During exercise, respiratory gas exchange, heart rate, blood pressure, ECG and ratings of perceived exertion will be continuously monitored. Venous blood specimens will be collected before exercise (baseline), at the end of the warm-up as well as 2 min, 10 min, and 30 min in recovery.

Group Type: EXPERIMENTAL

Performance testing

Intervention Type: DIAGNOSTIC_TEST

Performance testing on a bicycle ergometer.

Recreational athletes, female

Bicycle ergometer-based exercise testing. 15 min aerobic warm-up phase (1 W/kg) followed by a standardized but individualized ramp-bicycle ergometer protocol to reach maximal exercise capacity after 8 - 12 minutes. The exclusively aerobic energy supply during warm-up will be assessed by constant respiratory quotient and constant arterial lactate concentration (\<0.5 mmol in the last 5 min). During exercise, respiratory gas exchange, heart rate, blood pressure, ECG and ratings of perceived exertion will be continuously monitored. Venous blood specimens will be collected before exercise (baseline), at the end of the warm-up as well as 2 min, 10 min, and 30 min in recovery.

Group Type: EXPERIMENTAL

Performance testing

Intervention Type: DIAGNOSTIC_TEST

Performance testing on a bicycle ergometer.

Control, male

Venous blood specimens will be collected at the same time points in the absence of exercise.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Performance testing

Performance testing on a bicycle ergometer.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• All arms: ability to give written informed consent
• Arms 1- 3: inconspicuous medical examination (medical history, resting ECG, echocardiography)
• Elite athletes (arm1, cyclists): maximum oxygen uptake > 65 ml/kg/KG
• Elite athletes (arm1, cyclists): participation in cycling competitions on a regular basis
• Recreational athletes (arms 2 and 3): maximum oxygen uptake < 65 ml/kg/KG for male subjects and < 55 ml/kg/KG for female subjects

Exclusion Criteria

• All arms: unable to communicate adequately by language
• All arms: regular use of prescription drugs other than thyroxine or antihistamines
• All arms: alcohol consumption as equivalent doses averaging more than 40 g of pure alcohol per day
• All arms: use of illicit drugs
• All arms: known diseases of the cardiovascular system
• All arms: arterial hypertension over 160/90 mmHg at rest
• All arms: known pulmonary diseases, especially bronchial asthma
• All arms: surgery less than 4-6 months ago.
• All arms: abnormalities in the medical examination (medical history, resting ECG, echocardiography)
• Arms 1-3: orthopaedic diseases that preclude maximum exercise on a bicycle ergometer
• Elite athletes (arm1, cyclists): maximum oxygen uptake < 65 ml/kg/KG
• Recreational athletes (arms 2 and 3): maximum oxygen uptake > 65 ml/kg/KG for male subjects and > 55 ml/kg/KG for female subjects
• Arm 3: positive urine ß-HCG

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Department of Psychiatry University of Bonn

OTHER

Sponsor Role: collaborator

Paracelsus Medical University

OTHER

Sponsor Role: lead

Responsible Party

Jens Stepan, MD, PhD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jens Stepan, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Obstetrics and Gynecology, University Hospital Salzburg, Austria

Locations

Paracelsus Medical University

Salzburg, , Austria

Site Status: RECRUITING

Countries

Austria

Central Contacts

Jens Stepan, MD, PhD

Role: CONTACT

j.stepan@salk.at

+43(0)5725555625

Nils Gassen, PhD

Role: CONTACT

nils.gassen@ukbonn.de

+49(0)22828715793

Facility Contacts

Jens Stepan, MD, PhD

Role: primary

j.stepan@salk.at

+43(0)5725555625

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Other Identifiers

jestep032022

Identifier Type: -

Identifier Source: org_study_id