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临床试验/NCT05359744
NCT05359744
已完成
不适用

A Pilot-study on Multi-level Molecular Profiling of Peak Performance in Endurance Sports

Paracelsus Medical University1 个研究点 分布在 1 个国家目标入组 80 人2021年10月15日

概览

阶段
不适用
干预措施
Performance testing
疾病 / 适应症
Exercise
发起方
Paracelsus Medical University
入组人数
80
试验地点
1
主要终点
Proteomics and autophagy processes
状态
已完成
最后更新
2个月前

概览

简要总结

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.

详细描述

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.

注册库
clinicaltrials.gov
开始日期
2021年10月15日
结束日期
2022年8月15日
最后更新
2个月前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

发起方
Paracelsus Medical University
责任方
Principal Investigator
主要研究者

Jens Stepan, MD, PhD

Principal Investigator

Paracelsus Medical University

入排标准

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: Performance testing

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.

干预措施: Performance testing

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.

干预措施: Performance testing

Control, male

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

结局指标

主要结局

Proteomics and autophagy processes

时间窗: Before the exercise test (baseline), at the end of the 15 minute warm-up phase and 2 minutes, 10 minutes and 30 minutes after termination of the exercise test.

Change in protein levels of autophagy biomarkers (LC3II \& p62) of isolated PBMCs (peripheral blood mononuclear cells) by Western Blotting.

次要结局

  • Proteome patterns(Before the exercise test (baseline), at the end of the 15 minute warm-up phase and 2 minutes, 10 minutes and 30 minutes after termination of the exercise test.)
  • Metabolic processes(Before the exercise test (baseline), at the end of the 15 minute warm-up phase and 2 minutes, 10 minutes and 30 minutes after termination of the exercise test.)
  • Lipid profiling(Before the exercise test (baseline), at the end of the 15 minute warm-up phase and 2 minutes, 10 minutes and 30 minutes after termination of the exercise test.)
  • Phosphoproteome patterns(Before the exercise test (baseline), at the end of the 15 minute warm-up phase and 2 minutes, 10 minutes and 30 minutes after termination of the exercise test.)
  • Ubiquitinome patterns(Before the exercise test (baseline), at the end of the 15 minute warm-up phase and 2 minutes, 10 minutes and 30 minutes after termination of the exercise test.)
  • Epigenetic patterns(Before the exercise test (baseline), at the end of the 15 minute warm-up phase and 2 minutes, 10 minutes and 30 minutes after termination of the exercise test.)
  • Exosomal protein patterns(Before the exercise test (baseline), at the end of the 15 minute warm-up phase and 2 minutes, 10 minutes and 30 minutes after termination of the exercise test.)
  • Salivary cortisol levels(Before the exercise test (baseline), at the end of the 15 minute warm-up phase and 2 minutes, 10 minutes and 30 minutes after termination of the exercise test.)

研究点 (1)

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