Safety and Prevention of OveRTraining

NCT03833973 | Unknown DMC

• 1 other identifier: SuPpOrt-UTH
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Athletic training aims to increase and improve physical performance that is achieved through training overload combined with periods of rest and recovery. Overtraining syndrome (OTS) is associated with an imbalance between training and recovery. The symptoms associated with OTS vary between individuals and may reflect parasympathetic and/or sympathetic nervous system alterations as well as endocrine irregularities. The prevalence is not known, but it is usually reported among endurance athletes, such as cyclists, distance runners and triathletes. It appears that OTS represents a systemic inflammatory process with diffuse effects on the neurohormonal axis affecting host immunology and mood. Previous works, showed that cell-free DNA (cf-DNA) is correlated with the severity of excessive exercise-induced inflammation as well as with trauma and stroke severity suggesting that it might be used as a potential clinical marker for athletes with overtraining syndrome. Oxidative stress indices can be determined non-invasively and may reflect inflammatory responses after training suggesting that they could be used as clinical markers for the diagnosis of OTS. However, there are no available biomarkers to aid towards the diagnosis and/or prevention of OTS, except that of the persistence of unexplained underperformance despite an extensive recovery of the athlete. Therefore, the purpose of this study is to evaluate the potential of cf-DNA and selected oxidative stress variables as diagnostic biomarkers of OTS.

Conditions

Overtraining Syndrome

Keywords

Training; Cell free plasma DNA; Oxidative stress; Performance

Outcome Measures

Primary Outcomes (12)

• Change in cell free plasma DNA

  Cell free plasma DNA will be measured with real-time PCR in plasma samples.

  At baseline, at six months and at twelve months

• Change in Cortisol level

  Cortisol concentration will measured in serum

  At baseline, at six months and at twelve months

• Change in Testosterone level

  Testosterone concentration will be measured in serum

  At baseline, at six months and at twelve months

• Change in cytokine response

  Concentration of TNF-α, IL-6 and IL-10 will be measured in plasma.

  At baseline, at six months and at twelve months

• Change in creatine kinase in plasma

  Concentration of creatine kinase will be measured in plasma

  At baseline, at six months and at twelve months

• Change in uric acid in plasma

  Concentration of uric acid will be measured in plasma

  At baseline, at six months and at twelve months

• Change in protein carbonyls in blood

  Concentration of protein carbonyls will be measured in red blood cells

  At baseline, at six months and at twelve months

• Change in total antioxidant capacity

  Total antioxidant capacity will be measured in plasma

  At baseline, at six months and at twelve months

• Change in reduced glutathione in blood

  Concentration of reduced glutathione will be measured in in red blood cells

  At baseline, at six months and at twelve months

• Change in oxidized glutathione in blood

  Concentration of oxidized glutathione will be measured in red blood cells

  At baseline, at six months and at twelve months

• Change in catalase activity

  Catalase activity will be measured in red blood cells

  At baseline, at six months and at twelve months

• Change in malondialdehyde in blood

  Concentration of malondialdehyde will be measured in serum

  At baseline, at six months and at twelve months

Secondary Outcomes (15)

• Change in blood lactate concentration

  At baseline, at six months and at twelve months

• Change in peak torque

  At baseline, at six months and at twelve months

• Change in orthostatic heart rate.

  At baseline, at six months and at twelve months

• Change in jumping ability.

  At baseline, at six months and at twelve months

• Change in flexibility

  At baseline, at six months and at twelve months

Study Arms (2)

Runners

Long-distance runners, marathon runners, 5 km and 10 km runners, both female and male aged 20 - 40 years, participating in regular training and competitions.

Behavioral: Overtraining Monitoring

Soccer Players

High Level soccer players, both female and male aged 15-30, participating in all games

Behavioral: Overtraining Monitoring

Interventions

Overtraining Monitoring BEHAVIORAL

Athletes will be thoroughly monitored (i.e. training workload, match activities or event/race performance, markers of inflammation and oxidative stress as well as cell-free DNA) throughout the season in order to establish novel biomarkers that could function as either predictors or diagnostic tools of overtraining.

Runners; Soccer Players

Eligibility Criteria

• Age: 15 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Participants for the first group will be male and female long-distance, marathon, 5 km and 10 km runners aged 20-40 years. All of them will be active, elite-level runners , participating in regular competitive training. For the second group will be male and female high level soccer players aged 15-30 years

You may qualify if:

• Participants:
• should be long-distance runners, marathon runners, 5 km and 10 km runners.
• should be able to provide the daily training plan and a 7-day dietary recall every month.
• should be considered elite level runners.
• should be free of musculoskeletal injuries for at least one year before the study.
• Participants:
• should be elite soccer players.
• should be able to provide the daily training plan and a 7-day dietary recall.
• should be participated in matches.
• should be free of musculoskeletal injuries for at least one year before the study.

You may not qualify if:

• If participants:
• do not adhere to rules of the study.
• have a recent history of illness or injury .
• do not participate in competitive training.

Sponsors & Collaborators

• University of Thessaly: lead

Study Sites (1)

Exercise Biochemistry Laboratory, School of Physical Education & Sports Sciences, University of Thessaly

Trikala, 42100, Greece

RECRUITING

MeSH Terms

Conditions

Overtraining Syndrome

Condition Hierarchy (Ancestors)

Fatigue; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Vasiliki C Laschou, PhDc

  UNIVERSITY OF THESSALY, SCHOOL OF PHYSICAL EDUCATION & SPORTS SCIENCES

  PRINCIPAL INVESTIGATOR

Central Study Contacts

IOANNIS G FATOUROS, PhD

CONTACT

+30 24310 47047; ifatouros@pe.uth.gr

ATHANASIOS Z JAMURTAS, Prof

CONTACT

+30 24310 47054; ajamurt@pe.uth.gr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 5, 2018
• First Posted: February 7, 2019
• Study Start: January 1, 2018
• Primary Completion: June 1, 2020
• Study Completion: July 30, 2020
• Last Updated: December 27, 2019

Record last verified: 2019-12

Locations

GR (1)