Primary Prevention, Cardiovascular Risk Factor Management, Size of Response to TrainingSAusENCT01263522
Optimization of Preventive Effects of Physical Training
A study testing different training programs in people with Primary Prevention, Cardiovascular Risk Factor Management, Size of Response to Training, run by Universität des Saarlandes at 1 site in Germany.
Trial summary
Health-promoting effects of physical exercise are well-investigated especially for endurance activities. However, for different individuals, positive effects have different sizes, even non-responders are observed. Other forms of training, such as strength training and interval training, are less well investigated. Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Prevention, Cardiovascular Risk Factor Management, Size of Response to Training
- What is being tested?
- different training programs
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 266 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2010to Dec 2013
- 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 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- untrained
- healthy
- non-smoking
Who cannot join
- Contraindications for physical activity
- BMI > 30 kg/m2
- resting blood pressure > 160/100 mmHg
- diabetes
- total cholesterol > 300 mg/dl
- maximal oxygen uptake > 50 ml/min/kg for men and > 45 ml/min/kg for women respectively
- other complaints or diseases that might interfere with exercise training
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institute of Sports and Preventive Medicine, Saarland University, Bldg. B 8-2, 66123 Saarbrücken
Saarbrücken, Saarland, 66123
About this study
Official title: Optimization of Preventive Effects of Physical Training "Saarländische Ausdauer-Etappe (SAusE)"
Health-promoting effects of physical exercise are well-investigated especially for endurance activities. However, for different individuals, positive effects have different sizes, even non-responders are observed. Other forms of training, such as strength training and interval training, are less well investigated. Therefore, a comparative longitudinal training study is warranted to examine differences of preventive effects (outcome measures: ergometric descriptors of physical performance, established risk factors and prognostic factors for cardiovascular diseases) of continuous endurance training, interval training and strength endurance training.
In a second stage, the observed non-responders will perform a different type of training (cross-over). It is expected, that besides a comparative general efficacy evaluation of the three training types, improved recommendations for optimized individualization of training parameters can be formulated.
- Being tested
- different training programs, control condition
- Keywords
- primary prevention, endurance, cardiovascular risk factors, training, exercise, non-responder
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
different training programsOther
two different endurance programs and one strength endurance program
control conditionOther
unchanged lifestyle
| Study group | Role | What they receive |
|---|---|---|
| Endurance training | Experimental | Not described Receives: Other: different training programs |
| interval training | Experimental | Not described Receives: Other: different training programs |
| strength endurance training | Experimental | Not described Receives: Other: different training programs |
| control | Placebo comparator | Not described Receives: Other: control condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
VO2 max
determined during treadmill testing
Measured: 6 months
Secondary outcomes (3)
resting heart rate
Measured: 6 months
resting blood pressure
Measured: 6 months
blood lipid profile
ratio: total cholesterol/HDL-cholesterol
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 posted20 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Primary Prevention, Cardiovascular Risk Factor Management, Size of Response to TrainingStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 266 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universität des Saarlandes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01263522
- Sponsor's protocol ID
- SAusE2011
- Acronym
- SAusE
- Status last verified
- May 2018
- First submitted
- 17 Dec 2010
- Last updated
- 11 May 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wegmann M, Hecksteden A, Poppendieck W, Steffen A, Kraushaar J, Morsch A, Meyer T. Postexercise Hypotension as a Predictor for Long-Term Training-Induced Blood Pressure Reduction: A Large-Scale Randomized Controlled Trial. Clin J Sport Med. 2018 Nov;28(6):509-515. doi: 10.1097/JSM.0000000000000475.
PubMed 29189337Scharhag-Rosenberger F, Meyer T, Wegmann M, Ruppenthal S, Kaestner L, Morsch A, Hecksteden A. Irisin does not mediate resistance training-induced alterations in resting metabolic rate. Med Sci Sports Exerc. 2014 Sep;46(9):1736-43. doi: 10.1249/MSS.0000000000000286.
PubMed 24566753Hecksteden A, Wegmann M, Steffen A, Kraushaar J, Morsch A, Ruppenthal S, Kaestner L, Meyer T. Irisin and exercise training in humans - results from a randomized controlled training trial. BMC Med. 2013 Nov 5;11:235. doi: 10.1186/1741-7015-11-235.
PubMed 24191966
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Preventive Effects of Physical Training "Saarländische Ausdauer-Etappe (SAusE)"
- ClinicalTrials.gov ID
- NCT01263522
- Acronym / sponsor ID
- SAusE / SAusE2011
- Keywords
- primary prevention, endurance, cardiovascular risk factors, training, exercise, non-responder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 266 participants (actual)
- Lead sponsor
- Universität des SaarlandesUniversity, hospital or other
- Study start
- Dec 2010 (actual)
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 20 Dec 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.
Health-promoting effects of physical exercise are well-investigated especially for endurance activities. However, for different individuals, positive effects have different sizes, even non-responders are observed. Other forms of training, such as strength training and interval training, are less well investigated. Therefore, a comparative longitudinal training study is warranted to examine differences of preventive effects (outcome measures: ergometric descriptors of physical performance, established risk factors and prognostic factors for cardiovascular diseases) of continuous endurance training, interval training and strength endurance training.
In a second stage, the observed non-responders will perform a different type of training (cross-over). It is expected, that besides a comparative general efficacy evaluation of the three training types, improved recommendations for optimized individualization of training parameters can be formulated.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Endurance training | Experimental | Other: different training programs |
| interval training | Experimental | Other: different training programs |
| strength endurance training | Experimental | Other: different training programs |
| control | Placebo comparator | Other: control condition |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- untrained
- healthy
- non-smoking
Key exclusion criteria (7 listed)
- Contraindications for physical activity
- BMI > 30 kg/m2
- resting blood pressure > 160/100 mmHg
- diabetes
- total cholesterol > 300 mg/dl
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 |
|---|---|---|
| different training programstwo different endurance programs and one strength endurance program | Other | Endurance training, interval training, strength endurance training |
| control conditionunchanged lifestyle | Other | control |
Primary outcome
VO2 max
Time frame: 6 months
determined during treadmill testing
3 secondary outcomes
resting heart rate
Time frame: 6 months
resting blood pressure
Time frame: 6 months
blood lipid profile
Time frame: 6 months
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 11 May 2018.
- Derived from this study: PubMed 29189337Wegmann M, Hecksteden A, Poppendieck W, Steffen A, Kraushaar J, Morsch A, Meyer T. Postexercise Hypotension as a Predictor for Long-Term Training-Induced Blood Pressure Reduction: A Large-Scale Randomized Controlled Trial. Clin J Sport Med. 2018 Nov;28(6):509-515. doi: 10.1097/JSM.0000000000000475.
- Derived from this study: PubMed 24566753Scharhag-Rosenberger F, Meyer T, Wegmann M, Ruppenthal S, Kaestner L, Morsch A, Hecksteden A. Irisin does not mediate resistance training-induced alterations in resting metabolic rate. Med Sci Sports Exerc. 2014 Sep;46(9):1736-43. doi: 10.1249/MSS.0000000000000286.
- Derived from this study: PubMed 24191966Hecksteden A, Wegmann M, Steffen A, Kraushaar J, Morsch A, Ruppenthal S, Kaestner L, Meyer T. Irisin and exercise training in humans - results from a randomized controlled training trial. BMC Med. 2013 Nov 5;11:235. doi: 10.1186/1741-7015-11-235.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing different training programs in people with Primary Prevention, Cardiovascular Risk Factor Management, Size of Response to Training, 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 3 inclusion and 7 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 11 May 2018. 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. Some participants in this study may receive a placebo. 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?
VO2 max (time frame: 6 months). 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 NCT01263522, which also lists 3 linked publications.
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 11 May 2018.