Overtraining SyndromeSuPpOrtNCT03833973
Safety and Prevention of OveRTraining
An observational study of Overtraining Syndrome, run by University of Thessaly at 1 site in Greece.
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. Read more about this study
- Who is it for?
- Ages 15 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Overtraining Syndrome
- What is being tested?
- Overtraining Monitoring
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteGreece
- Study dates
- 1 Jan 2018to 30 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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
Who may be able to join
- 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:
Show all 10Show fewer
- 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.
Who cannot join
- If participants:
- do not adhere to rules of the study.
- have a recent history of illness or injury .
- do not participate in competitive training.
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Exercise Biochemistry Laboratory, School of Physical Education & Sports Sciences, University of Thessaly
Trikala, 42100
ATHANASIOS Z JAMURTAS, Prof, +302431047054, ajamurt@pe.uth.gr
IOANNIS KOUTEDAKIS, Prof, +302431047056, y.koutedakis@uth.gr
About this study
Official title: The Evaluation of Cell-Free Plasma DNA (cfDNA) and Oxidative Stress Indices as Biomarkers for the Diagnosis and Prevention of Overtraining
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.
Read the detailed 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.
- Conditions
- Overtraining Syndrome
- Being tested
- Overtraining Monitoring
- Keywords
- Training, Cell free plasma DNA, Oxidative stress, Performance
- Medical subject headings
- Overtraining Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Overtraining MonitoringBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Overtraining Monitoring | |
| Soccer Players | High Level soccer players, both female and male aged 15-30, participating in all games Receives: Behavioral: Overtraining Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cell free plasma DNA
Cell free plasma DNA will be measured with real-time PCR in plasma samples.
Measured: At baseline, at six months and at twelve months
Change in Cortisol level
Cortisol concentration will measured in serum
Measured: At baseline, at six months and at twelve months
Change in Testosterone level
Testosterone concentration will be measured in serum
Measured: 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.
Measured: At baseline, at six months and at twelve months
Change in creatine kinase in plasma
Concentration of creatine kinase will be measured in plasma
Measured: At baseline, at six months and at twelve months
Change in uric acid in plasma
Concentration of uric acid will be measured in plasma
Measured: 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
Measured: At baseline, at six months and at twelve months
Change in total antioxidant capacity
Total antioxidant capacity will be measured in plasma
Measured: 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
Measured: 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
Measured: At baseline, at six months and at twelve months
Change in catalase activity
Catalase activity will be measured in red blood cells
Measured: At baseline, at six months and at twelve months
Change in malondialdehyde in blood
Concentration of malondialdehyde will be measured in serum
Measured: At baseline, at six months and at twelve months
Secondary outcomes (15)
Change in blood lactate concentration
Blood lactate concentration will be measured during a maximal lactate steady-state test.
Measured: At baseline, at six months and at twelve months
Change in peak torque
Peak torque will be assessed on an isokinetic dynamometer at 60 degrees/sec
Measured: At baseline, at six months and at twelve months
Change in orthostatic heart rate.
Heart rate will be measured in a resting position and following 15 seconds of standing by heart rate monitor.
Measured: At baseline, at six months and at twelve months
Change in jumping ability.
Jumping ability will be assessed by measuring squat jump.
Measured: At baseline, at six months and at twelve months
Change in flexibility
Flexibility will be assessed through the sit and reach test.
Measured: At baseline, at six months and at twelve months
Change in body composition.
Body composition will be assessed by dual energy X-ray absorptiometry (DXA)
Measured: At baseline, at six months and at twelve months
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.
Measured: At baseline, at six months and at twelve months
Change in complete blood count
Complete blood count analysis will be performed on an automatic blood analyzer.
Measured: At baseline, at six months and at twelve months
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.
Measured: At baseline, at six months and at twelve months
Change in Yo-Yo IE2
Yo-Yo IE2 will be assessed using a standardized testing protocol.
Measured: At baseline, at six months and at twelve months
Change in Yo-Yo IR2
Yo-Yo IR2 will be assessed using a standardized testing protocol.
Measured: At baseline, at six months and at twelve months
Change in Spreed
Spreed will be assessed using a standardized testing protocol in 10 and 30 meters.
Measured: At baseline, at six months and at twelve months
Dietary intake
Dietary intake will be assessed using 7-day diet recalls.
Measured: At baseline, at six months and at twelve months
Change in jumping ability.
Jumping ability will be assessed by measuring counter-movement jump.
Measured: At baseline, at six months and at twelve months
Change in jumping ability.
Jumping ability will be assessed by measuring drop jump.
Measured: At baseline, at six months and at twelve months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2019
- Study start1 Jan 2018
- Primary completion1 Jun 2020 (estimated)
- Study completion30 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overtraining SyndromeStudies of the same condition, open and under way.
- More trials run by University of ThessalyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Thessaly
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ioannis G. Fatouros, University of Thessaly
- Investigators
- Vasiliki C Laschou, PhDc, Principal investigator, UNIVERSITY OF THESSALY, SCHOOL OF PHYSICAL EDUCATION & SPORTS SCIENCES
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03833973
- Sponsor's protocol ID
- SuPpOrt-UTH
- Acronym
- SuPpOrt
- Status last verified
- Dec 2019
- First submitted
- 5 Jun 2018
- Last updated
- 27 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of Cell-Free Plasma DNA (cfDNA) and Oxidative Stress Indices as Biomarkers for the Diagnosis and Prevention of Overtraining
- ClinicalTrials.gov ID
- NCT03833973
- Acronym / sponsor ID
- SuPpOrt / SuPpOrt-UTH
- Conditions
- Overtraining Syndrome
- Keywords
- Training, Cell free plasma DNA, Oxidative stress, Performance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of ThessalyUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jun 2020 (estimated)
- Study completion
- 30 Jul 2020 (estimated)
- First posted
- 7 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Runners | – | Behavioral: Overtraining MonitoringLong-distance runners, marathon runners, 5 km and 10 km runners, both female and male aged 20 - 40 years, participating in regular training and competitions. |
| Soccer Players | – | Behavioral: Overtraining MonitoringHigh Level soccer players, both female and male aged 15-30, participating in all games |
Who may qualify
- Ages
- 15 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (10 listed)
- 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.
- should be elite soccer players.
Key exclusion criteria (4 listed)
- do not adhere to rules of the study.
- have a recent history of illness or injury .
- do not participate in competitive training.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Overtraining MonitoringAthletes 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. | Behavioural | Runners, Soccer Players |
Primary outcome
Change in cell free plasma DNA
Time frame: At baseline, at six months and at twelve months
Cell free plasma DNA will be measured with real-time PCR in plasma samples.
Change in Cortisol level
Time frame: At baseline, at six months and at twelve months
Cortisol concentration will measured in serum
Change in Testosterone level
Time frame: At baseline, at six months and at twelve months
Testosterone concentration will be measured in serum
Change in cytokine response
Time frame: At baseline, at six months and at twelve months
Concentration of TNF-α, IL-6 and IL-10 will be measured in plasma.
Change in creatine kinase in plasma
Time frame: At baseline, at six months and at twelve months
Concentration of creatine kinase will be measured in plasma
Change in uric acid in plasma
Time frame: At baseline, at six months and at twelve months
Concentration of uric acid will be measured in plasma
Change in protein carbonyls in blood
Time frame: At baseline, at six months and at twelve months
Concentration of protein carbonyls will be measured in red blood cells
Change in total antioxidant capacity
Time frame: At baseline, at six months and at twelve months
Total antioxidant capacity will be measured in plasma
Change in reduced glutathione in blood
Time frame: At baseline, at six months and at twelve months
Concentration of reduced glutathione will be measured in in red blood cells
Change in oxidized glutathione in blood
Time frame: At baseline, at six months and at twelve months
Concentration of oxidized glutathione will be measured in red blood cells
Change in catalase activity
Time frame: At baseline, at six months and at twelve months
Catalase activity will be measured in red blood cells
Change in malondialdehyde in blood
Time frame: At baseline, at six months and at twelve months
Concentration of malondialdehyde will be measured in serum
15 secondary outcomes
Change in blood lactate concentration
Time frame: At baseline, at six months and at twelve months
Change in peak torque
Time frame: At baseline, at six months and at twelve months
Change in orthostatic heart rate.
Time frame: At baseline, at six months and at twelve months
Change in jumping ability.
Time frame: At baseline, at six months and at twelve months
Change in flexibility
Time frame: At baseline, at six months and at twelve months
Change in body composition.
Time frame: At baseline, at six months and at twelve months
Change in delay onset of muscle soreness (DOMS)
Time frame: At baseline, at six months and at twelve months
Change in complete blood count
Time frame: At baseline, at six months and at twelve months
Change in RSA
Time frame: At baseline, at six months and at twelve months
Change in Yo-Yo IE2
Time frame: At baseline, at six months and at twelve months
Change in Yo-Yo IR2
Time frame: At baseline, at six months and at twelve months
Change in Spreed
Time frame: At baseline, at six months and at twelve months
Dietary intake
Time frame: At baseline, at six months and at twelve months
Change in jumping ability.
Time frame: At baseline, at six months and at twelve months
Change in jumping ability.
Time frame: At baseline, at six months and at twelve months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vasiliki C Laschou, PhDc principal investigator
UNIVERSITY OF THESSALY, SCHOOL OF PHYSICAL EDUCATION & SPORTS SCIENCES
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Overtraining Syndrome, run by University of Thessaly at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact IOANNIS G FATOUROS, PhD (+30 24310 47047, ifatouros@pe.uth.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cell free plasma DNA (time frame: At baseline, at six months and at twelve months). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2019.