Safety and Prevention of OveRTraining

Overtraining Syndrome Clinical Trial

— SuPpOrt  

Official title:

The Evaluation of Cell-Free Plasma DNA (cfDNA) and Oxidative Stress Indices as Biomarkers for the Diagnosis and Prevention of Overtraining

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03833973
• Other study ID #: SuPpOrt-UTH
• Status: Recruiting
• Start date: January 1, 2018
• Est. completion date: July 30, 2020

Study information

• Verified date: December 2019
• Source: University of Thessaly
• Contact: IOANNIS G FATOUROS, PhD
• Phone: +30 24310 47047
• Email: ifatouros[@]pe.uth.gr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

A total number of 15 elite-level runners (both male and female) and 80-100 soccer players (both male and female) will participate in the study.The day when participants (runners) will arrive at the lab early in the morning, after an overnight fast. They will have their blood pressure and orthostatic heart rate measured and they will also provide a blood sample. Immediately after participants' body composition will be assessed by dual energy X-ray absorptiometry (DXA). Then, they will perform the Meeusen test providing a second blood sample immediately after the test. During the subsequent 4-hour resting period, the participants followed by assessment of joint mobility, delayed onset of muscle soreness, flexibility and vertical jump performance after that lower limb peak torque by isokinetic dynamometer. A second Meeusen test will take place after the resting period with blood sampling post-testing. Then, participants will have a 3-hour rest, after which they will visit the lab again in order to perform the running economy testing protocol and a maximal lactate steady state test. Finally, participants will complete POMS-, quality of sleep- and symptomatology-related questionnaires and will be taught on how to complete dietary recalls. Over the subsequent 12-month period participants will provide the investigator with a detailed report of their training plan and a symptomatology questionnaire every month. These measurements take place for all participants in two different periods, in transitional period/baseline and in middle season (berore tha main race). If someone of participants manifest the symptoms of overtraining, they perform the protocol of measurements again. The day when participants (soccer players) will arrive at the lab early in the morning, after an overnight fast. They will have their blood pressure and orthostatic heart rate measured and they will also provide a blood sample. Immediately after participants' body composition will be assessed by dual energy X-ray absorptiometry (DXA). The participants followed by assessment of joint mobility, delayed onset of muscle soreness, flexibility and vertical jump performance after that lower limb peak torque by isokinetic dynamometer. After resting, they will measurement the maximum oxygen uptake in stress test on the aisle. The next days, in football players take place in field tests, will measure the Speed in 10, 30 meters, Yo-Yo IE2 (Intermittent Endurance 2), Yo-Yo IR2 (Intermittent Recovery 2) and Repeated Sprint Ability (RSA). Finally, participants (soccer players) will complete POMS-, quality of sleep- and symptomatology-related questionnaires and will be taught on how to complete dietary recalls.These measurements take place for all participants in two different periods, in transitional period/baseline and in middle season (berore tha main race). If someone of participants manifest the symptoms of overtraining, they perform the protocol again.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 30, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 40 Years

Eligibility

Inclusion Criteria for Runners:

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.

Inclusion Criteria for Soccer Players:

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.

Exclusion Criteria (both Runners and Soccer Players):

If participants:

• do not adhere to rules of the study.

• have a recent history of illness or injury .

• do not participate in competitive training.

Related Conditions & MeSH terms

• Overtraining Syndrome

Intervention

Behavioral:
• Overtraining Monitoring
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.

Locations

Country	Name	City	State
Greece	Exercise Biochemistry Laboratory, School of Physical Education & Sports Sciences, University of Thessaly	Tríkala

Sponsors (1)

Lead Sponsor	Collaborator
University of Thessaly

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change in Cortisol level	Cortisol concentration will measured in serum	At baseline, at six months and at twelve months
Primary	Change in Testosterone level	Testosterone concentration will be measured in serum	At baseline, at six months and at twelve months
Primary	Change in cytokine response	Concentration of TNF-a, IL-6 and IL-10 will be measured in plasma.	At baseline, at six months and at twelve months
Primary	Change in creatine kinase in plasma	Concentration of creatine kinase will be measured in plasma	At baseline, at six months and at twelve months
Primary	Change in uric acid in plasma	Concentration of uric acid will be measured in plasma	At baseline, at six months and at twelve months
Primary	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
Primary	Change in total antioxidant capacity	Total antioxidant capacity will be measured in plasma	At baseline, at six months and at twelve months
Primary	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
Primary	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
Primary	Change in catalase activity	Catalase activity will be measured in red blood cells	At baseline, at six months and at twelve months
Primary	Change in malondialdehyde in blood	Concentration of malondialdehyde will be measured in serum	At baseline, at six months and at twelve months
Secondary	Change in blood lactate concentration	Blood lactate concentration will be measured during a maximal lactate steady-state test.	At baseline, at six months and at twelve months
Secondary	Change in peak torque	Peak torque will be assessed on an isokinetic dynamometer at 60 degrees/sec	At baseline, at six months and at twelve months
Secondary	Change in orthostatic heart rate.	Heart rate will be measured in a resting position and following 15 seconds of standing by heart rate monitor.	At baseline, at six months and at twelve months
Secondary	Change in jumping ability.	Jumping ability will be assessed by measuring squat jump.	At baseline, at six months and at twelve months
Secondary	Change in flexibility	Flexibility will be assessed through the sit and reach test.	At baseline, at six months and at twelve months
Secondary	Change in body composition.	Body composition will be assessed by dual energy X-ray absorptiometry (DXA)	At baseline, at six months and at twelve months
Secondary	Change in delay onset of muscle soreness (DOMS)	DOMS will be assessed by muscle palpation while participants are laying , standing and after performing 3 squats.	At baseline, at six months and at twelve months
Secondary	Change in complete blood count	Complete blood count analysis will be performed on an automatic blood analyzer.	At baseline, at six months and at twelve months
Secondary	Change in RSA	5 x 30 m sprints will be performed with 25 seconds rest in-between. Mean time for 5 sprints and fatigue index will be calculated.	At baseline, at six months and at twelve months
Secondary	Change in Yo-Yo IE2	Yo-Yo IE2 will be assessed using a standardized testing protocol.	At baseline, at six months and at twelve months
Secondary	Change in Yo-Yo IR2	Yo-Yo IR2 will be assessed using a standardized testing protocol.	At baseline, at six months and at twelve months
Secondary	Change in Spreed	Spreed will be assessed using a standardized testing protocol in 10 and 30 meters.	At baseline, at six months and at twelve months
Secondary	Dietary intake	Dietary intake will be assessed using 7-day diet recalls.	At baseline, at six months and at twelve months
Secondary	Change in jumping ability.	Jumping ability will be assessed by measuring counter-movement jump.	At baseline, at six months and at twelve months
Secondary	Change in jumping ability.	Jumping ability will be assessed by measuring drop jump.	At baseline, at six months and at twelve months