Primary PreventionNCT00934206
Predictors of Individual Training Effectiveness in Preventive Exercise
A study testing Endurance training in people with Primary Prevention, run by Universität des Saarlandes at 1 site in Germany.
Trial summary
Physical exercise elicits beneficial changes in the body. These concern physical performance but also improvements in virtually all known risk factors for cardiovascular disease. Read more about this study
- Who is it for?
- Ages 35 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Prevention
- What is being tested?
- Endurance training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2009to Dec 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 35 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy subjects
- age 35-60
Who cannot join
- Any medical condition requiring medication (except thyroid hormones)
- Other complaints that might interfere with exercise
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institute of Sports- and Preventive Medicine, Saarland University
Saarbrücken, Saarland, 66123
About this study
Official title: Pilot Study to Find Predictors of Individual Training Effectiveness in Preventive Exercise
Physical exercise elicits beneficial changes in the body. These concern physical performance but also improvements in virtually all known risk factors for cardiovascular disease. Yet, the extent of individual benefit differs considerably even within homogenous groups and the prediction of individual training effectiveness is not yet possible. This study aims to find predictors of individual training effectiveness.
- Conditions
- Primary Prevention
- Being tested
- Endurance training
- Keywords
- Exercise, healthy subjects
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endurance trainingBehavioural
running / walking at 60 % heart rate reserve 4 times per week for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Training | Experimental | One month of endurance training (running / walking at 60 % heart rate reserve for 45 min 4 times per week) Receives: Behavioral: Endurance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation of possible predictors with training effects on cardiovascular risk factors
Measured: within study periode
Secondary outcomes (1)
Correlation of possible predictors with improvements in physical performance
Measured: within study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2009 (estimated)
- Study startAug 2009
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary PreventionStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universität des Saarlandes
- Sponsor type
- University, hospital or other
- Investigators
- Anne Krieg, M.D., Principal investigator, Institute of Sports- and Preventive Medicine, Saarland University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00934206
- Sponsor's protocol ID
- 01/2009
- Status last verified
- Jun 2011
- First submitted
- 7 Jul 2009
- Last updated
- 26 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Hecksteden A, Grutters T, Meyer T. Associations between acute and chronic effects of exercise on indicators of metabolic health: a pilot training trial. PLoS One. 2013 Nov 21;8(11):e81181. doi: 10.1371/journal.pone.0081181. eCollection 2013.
PubMed 24278393
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Find Predictors of Individual Training Effectiveness in Preventive Exercise
- ClinicalTrials.gov ID
- NCT00934206
- Acronym / sponsor ID
- 01/2009
- Conditions
- Primary Prevention
- Keywords
- Exercise, healthy subjects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Universität des SaarlandesUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 8 Jul 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.
Physical exercise elicits beneficial changes in the body. These concern physical performance but also improvements in virtually all known risk factors for cardiovascular disease. Yet, the extent of individual benefit differs considerably even within homogenous groups and the prediction of individual training effectiveness is not yet possible. This study aims to find predictors of individual training effectiveness.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Training | Experimental | Behavioral: Endurance trainingOne month of endurance training (running / walking at 60 % heart rate reserve for 45 min 4 times per week) |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- healthy subjects
- age 35-60
Key exclusion criteria (2 listed)
- Any medical condition requiring medication (except thyroid hormones)
- Other complaints that might interfere with exercise
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 |
|---|---|---|
| Endurance trainingrunning / walking at 60 % heart rate reserve 4 times per week for 4 weeks | Behavioural | Training |
Primary outcome
correlation of possible predictors with training effects on cardiovascular risk factors
Time frame: within study periode
1 secondary outcome
Correlation of possible predictors with improvements in physical performance
Time frame: within study period
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 26 Aug 2011.
- Derived from this study: PubMed 24278393Hecksteden A, Grutters T, Meyer T. Associations between acute and chronic effects of exercise on indicators of metabolic health: a pilot training trial. PLoS One. 2013 Nov 21;8(11):e81181. doi: 10.1371/journal.pone.0081181. eCollection 2013.
- Primary sponsor and study locationLink provided by the sponsor.
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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.
Anne Krieg, M.D. principal investigator
Institute of Sports- and Preventive Medicine, Saarland University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endurance training in people with Primary Prevention, 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 2 inclusion and 2 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 26 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?
correlation of possible predictors with training effects on cardiovascular risk factors (time frame: within study periode). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00934206, which also lists 1 linked publication.
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 26 Aug 2011.