Healthy MenNCT00900107
Time-Dependent Mobilization of Circulating Progenitor Cells During Strenuous Exercise in Healthy Individuals
A study testing Exercise in people with Healthy Men, run by University of Leipzig at 1 site in Germany.
Trial summary
Only few data are available on the influence of strenuous exercise on the content of circulating progenitor cells and especially the timeframe of their release. The aim of the present study was to investigate the potential influence of 4 hours of cycling on the time-dependent release of progenitor cells. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Men
- What is being tested?
- Exercise
- Type of treatment
- Surgery or procedure
- How many people
- 18 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2008to Mar 2009
- Phase
- Interventional
- 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 18 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy volunteers
Who cannot join
- cardiovascular disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Time Dependent Mobilization of Circulating Progenitor Cells During Strenuous Exercise in Healthy Individuals.
Only few data are available on the influence of strenuous exercise on the content of circulating progenitor cells and especially the timeframe of their release. The aim of the present study was to investigate the potential influence of 4 hours of cycling on the time-dependent release of progenitor cells.
Read the detailed description
- What is the response of hematopoietic and endothelial progenitor cells after a standardized prolonged endurance exercise?
- What is the kinetic of cell mobilization during this standardized exercise?
- Conditions
- Healthy Men
- Being tested
- Exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial progenitor cells (EPC) release on
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startSep 2008
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy MenStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Collaborators
- University of Jena
- Responsible party
- Principal investigator, Sven Möbius-Winkler, University of Leipzig
- Investigators
- Gerhard C Schuler, Prof. Dr., Study director, Heart Center Leipzig
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00900107
- Sponsor's protocol ID
- SMW 02
- Status last verified
- May 2009
- First submitted
- 1 May 2009
- Last updated
- 27 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time Dependent Mobilization of Circulating Progenitor Cells During Strenuous Exercise in Healthy Individuals.
- ClinicalTrials.gov ID
- NCT00900107
- Acronym / sponsor ID
- SMW 02
- Conditions
- Healthy Men
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Collaborators
- University of Jena
- Study start
- Sep 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 12 May 2009 (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.
Only few data are available on the influence of strenuous exercise on the content of circulating progenitor cells and especially the timeframe of their release. The aim of the present study was to investigate the potential influence of 4 hours of cycling on the time-dependent release of progenitor cells.
Detailed description
- What is the response of hematopoietic and endothelial progenitor cells after a standardized prolonged endurance exercise?
- What is the kinetic of cell mobilization during this standardized exercise?
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy volunteers
Key exclusion criteria (1 listed)
- cardiovascular disease
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 |
|---|---|---|
| Exercise | Procedure or surgery | – |
Primary outcome
Endothelial progenitor cells (EPC) release on
Time frame: 4 hours
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 27 Oct 2016.
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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.
Gerhard C Schuler, Prof. Dr. study director
Heart Center Leipzig
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Healthy Men, run by University of Leipzig 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 27 Oct 2016. 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?
Endothelial progenitor cells (EPC) release on (time frame: 4 hours). 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 Oct 2016.