Health StatusNCT01171222
Health Status and Cardiovascular Stress of Veteran Soccer Players
An observational study of Health Status and Stress, run by Universität des Saarlandes at 1 site in Germany.
Trial summary
This study shall provide missing descriptive data on health status of veteran players and potential preventive effects of soccer at an age of 40 to 60 years. The investigation represents a cross-sectional examination of cardiovascular parameters and metabolic stress induced by training and competition. Read more about this study
- Who is it for?
- Ages 40 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Health Status, Stress
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2010to Jan 2011
- 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 40 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: veteran soccer players from Saarland County, Germany
Who may be able to join
- Male veteran soccer players aged 40 years and older, who are member of a club veteran team
Who cannot join
- Diseases or injuries which are contraindications for physical exercise
Trial locations and contacts
1 site in 1 country.
About this study
This study shall provide missing descriptive data on health status of veteran players and potential preventive effects of soccer at an age of 40 to 60 years. The investigation represents a cross-sectional examination of cardiovascular parameters and metabolic stress induced by training and competition. Additionally, orthopedic and other medical risks are to be revealed, and options should be developed to minimize these risks, e.g. by preventive measures included in training or rule modifications.
Read the detailed description
Facing the demographic trends in Western societies there is an expected increase in interest in soccer for males between 40 and 60 years. Positive effects of such an activity on health can be suspected based on some studies and analogous conclusions. However, no sufficient database is available yet. Moreover, the range of cardiovascular risk factors or pre-existing diseases for this specific population is not known.
This study shall provide missing descriptive data on health status of veteran players and potential preventive effects of soccer at an age of 40 to 60 years. The investigation represents a cross-sectional examination of cardiovascular parameters and metabolic stress induced by training and competition. Additionally, orthopedic and other medical risks are to be revealed, and options should be developed to minimize these risks, e.g. by preventive measures included in training or rule modifications.
- Conditions
- Health Status, Stress
- Keywords
- soccer, prevention, veteran athletes, exercise, Cardiovascular
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| veteran soccer players from Saarland County, Germany | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Descriptive data from medical check up and physiological testing
The investigation represents a cross-sectional examination of cardiovascular parameters and metabolic stress induced by training and competition:
- resting ECG
- stress ECG
- blood sample
- VO2max
- visit of training and competition (including the measurement of heart rate and blood lactate)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2010 (estimated)
- Study startMar 2010
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health StatusStudies of the same condition, open and under way.
- 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
- Universität des Saarlandes
- Sponsor type
- University, hospital or other
- Investigators
- Tim Meyer, Prof. Dr., Principal investigator, Universität des Saarlandes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01171222
- Sponsor's protocol ID
- Saarland University
- Status last verified
- Jul 2010
- First submitted
- 22 Jul 2010
- Last updated
- 29 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Status and Cardiovascular Stress of Veteran Soccer Players
- ClinicalTrials.gov ID
- NCT01171222
- Acronym / sponsor ID
- Saarland University
- Conditions
- Health Status, Stress
- Keywords
- soccer, prevention, veteran athletes, exercise, Cardiovascular
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Universität des SaarlandesUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 28 Jul 2010 (estimated)
- 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.
This study shall provide missing descriptive data on health status of veteran players and potential preventive effects of soccer at an age of 40 to 60 years. The investigation represents a cross-sectional examination of cardiovascular parameters and metabolic stress induced by training and competition. Additionally, orthopedic and other medical risks are to be revealed, and options should be developed to minimize these risks, e.g. by preventive measures included in training or rule modifications.
Detailed description
Facing the demographic trends in Western societies there is an expected increase in interest in soccer for males between 40 and 60 years. Positive effects of such an activity on health can be suspected based on some studies and analogous conclusions. However, no sufficient database is available yet. Moreover, the range of cardiovascular risk factors or pre-existing diseases for this specific population is not known.
This study shall provide missing descriptive data on health status of veteran players and potential preventive effects of soccer at an age of 40 to 60 years. The investigation represents a cross-sectional examination of cardiovascular parameters and metabolic stress induced by training and competition. Additionally, orthopedic and other medical risks are to be revealed, and options should be developed to minimize these risks, e.g. by preventive measures included in training or rule modifications.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| veteran soccer players from Saarland County, Germany | – | – |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- veteran soccer players from Saarland County, Germany
Key inclusion criteria (1 listed)
- Male veteran soccer players aged 40 years and older, who are member of a club veteran team
Key exclusion criteria (1 listed)
- Diseases or injuries which are contraindications for physical exercise
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Descriptive data from medical check up and physiological testing
Time frame: 6 months
The investigation represents a cross-sectional examination of cardiovascular parameters and metabolic stress induced by training and competition: * resting ECG * stress ECG * blood sample * VO2max * visit of training and competition (including the measurement of heart rate and blood lactate)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2011.
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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.
Tim Meyer, Prof. Dr. principal investigator
Universität des Saarlandes
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 Health Status and Stress, run by Universität des Saarlandes at 1 site in Germany.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 29 Aug 2011. 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Descriptive data from medical check up and physiological testing (time frame: 6 months). 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 29 Aug 2011.