Metabolic SyndromeSPRINTNCT00686244
IT-Based Training in Metabolic Syndrome
A study testing Combined 3-monthly endurance and strength training in people with Metabolic Syndrome, run by Technical University of Munich at 1 site in Germany.
Trial summary
Prospective, randomized, single center, controlled intervention study to investigate the effect of a systematic combined personal and IT-based training on the outcome of patients with metabolic syndrome. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Combined 3-monthly endurance and strength training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteGermany
- Study dates
- Apr 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- males and females between 20 and 60 years
- Staff of the Fa. BMW
- written informed consent after detailed education
- BMI 25-35 kg/m2
- ≤ 1x/week sport respectively exercise
- metabolic syndrome (at least 3 of 5 criteria)
Who cannot join
- > 1x/week physical activity
- BMI < 25 kg/m2 or > 35 kg/m2
- Florid acute or chronic disease of any kind prohibiting regular physical activity
- Diabetes mellitus
- pregnancy or lactation
- Drug or alcohol abuse
Trial locations and contacts
1 site in 1 country.
Germany1 site
Lehrstuhl für Praeventive und Rehabilitative Sportmedizin Klinikum Rechts der Isar, Technical University of Munich
Munich, 80809
About this study
Official title: Effect of Personal and IT Based Training to Performance, Metabolic Profil and Quality of Life by Patients With Metabolic Syndrome
Prospective, randomized, single center, controlled intervention study to investigate the effect of a systematic combined personal and IT-based training on the outcome of patients with metabolic syndrome.
Read the detailed description
The study settles in the field of primary prevention and aims to change lifestyle of patients with metabolic syndrome with a new combination of personal and IT-based training specially designed für obese people with risk factors. Procedures that are similar for all participants are summarized in a training program whereas individual aspects of physical activity like initial education and exercise tests are still performed by doctors and trainers. Before and after three months of training anthropometric parameters, laboratory and exercise capacity are examined and analyzed. The intervention group is characterized by a predetermined exercise program whereas the control group is allowed to practise without detailed instructions. The practicability and the effect on health status of the combined personal and IT-based training in the intervention group is compared with the independent training of the control group. After 6 months and again after 12 months the measurements are repeated to evaluate a lasting effect of the program.
- Conditions
- Metabolic Syndrome
- Being tested
- Combined 3-monthly endurance and strength training
- Keywords
- metabolic syndrome, physical activity, overweight, malnutrition, prevention
- Medical subject headings
- Metabolic Syndrome, Motor Activity, Overweight, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined 3-monthly endurance and strength trainingOther
Combined 3-monthly endurance- (3x/week) and strength training (2x/week) with moderate beginning and continuous increase of volume, duration and intensity, orientated on metabolic equivalents (MET).
Main sport: walking, walk and cycling. Addition with other activities are possible up to once a week to achieve the basal metabolism
| Study group | Role | What they receive |
|---|---|---|
| Training Group | Experimental | Combined 3-monthly endurance- (3x/week) and strength training (2x/week) with moderate beginning and continuous increase of volume, duration and intensity, orientated on metabolic equivalents (MET).
Main sport: walking, walk and cycling. Addition with other activities are possible up to once a week to achieve the basal metabolism Receives: Other: Combined 3-monthly endurance and strength training |
| Control Group | No intervention | No guided training. Exercise optional after detailed consulting and handing over an information dossier for adequate physical activity. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the effect of a combined personal and IT- based training on the performance at the metabolic anaerobe barrier of patients with impending or manifest metabolic syndrome compared to a control group with conventional consulting
Measured: 12 months
Secondary outcomes (5)
Evaluation of the effect of IT based training on metabolic parameters
Measured: 12 months
Evaluation of the efficacy of IT based training to an increase of activity by patients with impending or manifest metabolic syndrome
Measured: 12 months
Change in quality of life and subjective assumption of health sensation
Measured: 12 months
Change in anthropometric parameters
Measured: 12 months
Raise of maximum performance (max. ergometric performance)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2008 (estimated)
- Study startApr 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.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Investigators
- Martin Halle, P.D., Principal investigator, Department of Sports Medicine, Klinikum rechts der Isar, Technical University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00686244
- Sponsor's protocol ID
- FKZ01FD0609
- Acronym
- SPRINT
- Status last verified
- Mar 2009
- First submitted
- 21 May 2008
- Last updated
- 12 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Ainsworth BE, Anderson LA, Becker DM, Blalock SJ, Brown DR, Brownson RC, Brownstein N, Cornell CE, Devellis BM, Finnegan LP, Folger S, Fulton JE, Groff JY, Herman C, Jones D, Keyserling TC, Matson Koffman D, Lewis C, Masse LC, McKeown RE, Orenstein D, Spadaro AJ; Women's Health Initiative Community Prevention Study Collaborators. Observations from the CDC. Community Prevention Study: contributions to women's health and prevention research. J Womens Health Gend Based Med. 2001 Dec;10(10):913-20. doi: 10.1089/152460901317193495. No abstract available.
PubMed 11788102Bullinger M, Kirchberger I. SF-36. Fragebogen zum Gesundheitszustand. Göttingen, Hogrefe 1998
Centers for disease control. Overweight and obesity. www.cdc.gov/nccdphp/dnpa/obesity/trend/maps/index.htm
Chisholm DM, Collis ML, Kulak LL, Davenport W, Gruber N. Physical activity readiness. Br Col Med J 17(1975);375-78
Deutsches Netzwerk für Betriebliche Gesundheitsförderung. www.dnbgf.de
Frey I, Berg A, Grathwohl D, Keul J. [Freiburg Questionnaire of physical activity--development, evaluation and application]. Soz Praventivmed. 1999;44(2):55-64. doi: 10.1007/BF01667127. German.
PubMed 10407953Haskell WL, Lee IM, Pate RR, Powell KE, Blair SN, Franklin BA, Macera CA, Heath GW, Thompson PD, Bauman A. Physical activity and public health: updated recommendation for adults from the American College of Sports Medicine and the American Heart Association. Med Sci Sports Exerc. 2007 Aug;39(8):1423-34. doi: 10.1249/mss.0b013e3180616b27.
PubMed 17762377Konig D, Bonner G, Berg A. [The role of adiposity and inactivity in primary prevention of cardiovascular disease]. Herz. 2007 Oct;32(7):553-9. doi: 10.1007/s00059-007-3019-7. German.
PubMed 17972028Nationale Verzehrstudie II. Bundesministerium für Ernährung, Landwirtschaft, und Verbraucherschutz. www.was-esse-ich.de
Parizkova J, Buzkova P. Relationship between skinfold thickness measured by Harpenden caliper and densitometric analysis of total body fat in men. Hum Biol. 1971 Feb;43(1):16-21. No abstract available.
PubMed 5556752Statistisches Bundesamt. www.destatis.de
Sullivan PW, Morrato EH, Ghushchyan V, Wyatt HR, Hill JO. Obesity, inactivity, and the prevalence of diabetes and diabetes-related cardiovascular comorbidities in the U.S., 2000-2002. Diabetes Care. 2005 Jul;28(7):1599-603. doi: 10.2337/diacare.28.7.1599.
PubMed 15983307Vatten LJ, Nilsen TI, Romundstad PR, Droyvold WB, Holmen J. Adiposity and physical activity as predictors of cardiovascular mortality. Eur J Cardiovasc Prev Rehabil. 2006 Dec;13(6):909-15. doi: 10.1097/01.hjr.0000239463.80390.52.
PubMed 17143122Graham I, Atar D, Borch-Johnsen K, Boysen G, Burell G, Cifkova R, Dallongeville J, De Backer G, Ebrahim S, Gjelsvik B, Herrmann-Lingen C, Hoes A, Humphries S, Knapton M, Perk J, Priori SG, Pyorala K, Reiner Z, Ruilope L, Sans-Menendez S, Op Reimer WS, Weissberg P, Wood D, Yarnell J, Zamorano JL, Walma E, Fitzgerald T, Cooney MT, Dudina A, Vahanian A, Camm J, De Caterina R, Dean V, Dickstein K, Funck-Brentano C, Filippatos G, Hellemans I, Kristensen SD, McGregor K, Sechtem U, Silber S, Tendera M, Widimsky P, Zamorano JL, Altiner A, Bonora E, Durrington PN, Fagard R, Giampaoli S, Hemingway H, Hakansson J, Kjeldsen SE, Larsen ML, Mancia G, Manolis AJ, Orth-Gomer K, Pedersen T, Rayner M, Ryden L, Sammut M, Schneiderman N, Stalenhoef AF, Tokgozoglu L, Wiklund O, Zampelas A; European Society of Cardiology (ESC); European Association for Cardiovascular Prevention and Rehabilitation (EACPR); Council on Cardiovascular Nursing; European Association for Study of Diabetes (EASD); International Diabetes Federation Europe (IDF-Europe); European Stroke Initiative (EUSI); International Society of Behavioural Medicine (ISBM); European Society of Hypertension (ESH); European Society of General Practice/Family Medicine (ESGP/FM/WONCA); European Heart Network (EHN). European guidelines on cardiovascular disease prevention in clinical practice: executive summary. Fourth Joint Task Force of the European Society of Cardiology and other societies on cardiovascular disease prevention in clinical practice (constituted by representatives of nine societies and by invited experts). Eur J Cardiovasc Prev Rehabil. 2007 Sep;14 Suppl 2:E1-40. doi: 10.1097/01.hjr.0000277984.31558.c4. No abstract available.
PubMed 17726406
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Personal and IT Based Training to Performance, Metabolic Profil and Quality of Life by Patients With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT00686244
- Acronym / sponsor ID
- SPRINT / FKZ01FD0609
- Conditions
- Metabolic Syndrome
- Keywords
- metabolic syndrome, physical activity, overweight, malnutrition, prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Study start
- Apr 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 29 May 2008 (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.
Prospective, randomized, single center, controlled intervention study to investigate the effect of a systematic combined personal and IT-based training on the outcome of patients with metabolic syndrome.
Detailed description
The study settles in the field of primary prevention and aims to change lifestyle of patients with metabolic syndrome with a new combination of personal and IT-based training specially designed für obese people with risk factors. Procedures that are similar for all participants are summarized in a training program whereas individual aspects of physical activity like initial education and exercise tests are still performed by doctors and trainers. Before and after three months of training anthropometric parameters, laboratory and exercise capacity are examined and analyzed. The intervention group is characterized by a predetermined exercise program whereas the control group is allowed to practise without detailed instructions. The practicability and the effect on health status of the combined personal and IT-based training in the intervention group is compared with the independent training of the control group. After 6 months and again after 12 months the measurements are repeated to evaluate a lasting effect of the program.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training Group | Experimental | Other: Combined 3-monthly endurance and strength trainingCombined 3-monthly endurance- (3x/week) and strength training (2x/week) with moderate beginning and continuous increase of volume, duration and intensity, orientated on metabolic equivalents (MET). Main sport: walking, walk and cycling. Addition with other activities are possible up to once a week to achieve the basal metabolism |
| Control Group | No intervention | –No guided training. Exercise optional after detailed consulting and handing over an information dossier for adequate physical activity. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- males and females between 20 and 60 years
- Staff of the Fa. BMW
- written informed consent after detailed education
- BMI 25-35 kg/m2
- ≤ 1x/week sport respectively exercise
Key exclusion criteria (6 listed)
- > 1x/week physical activity
- BMI < 25 kg/m2 or > 35 kg/m2
- Florid acute or chronic disease of any kind prohibiting regular physical activity
- Diabetes mellitus
- pregnancy or lactation
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 |
|---|---|---|
| Combined 3-monthly endurance and strength trainingCombined 3-monthly endurance- (3x/week) and strength training (2x/week) with moderate beginning and continuous increase of volume, duration and intensity, orientated on metabolic equivalents (MET). Main sport: walking, walk and cycling. Addition with other activities are possible up to once a week to achieve the basal metabolism | Other | Training Group |
Primary outcome
Evaluation of the effect of a combined personal and IT- based training on the performance at the metabolic anaerobe barrier of patients with impending or manifest metabolic syndrome compared to a control group with conventional consulting
Time frame: 12 months
5 secondary outcomes
Evaluation of the effect of IT based training on metabolic parameters
Time frame: 12 months
Evaluation of the efficacy of IT based training to an increase of activity by patients with impending or manifest metabolic syndrome
Time frame: 12 months
Change in quality of life and subjective assumption of health sensation
Time frame: 12 months
Change in anthropometric parameters
Time frame: 12 months
Raise of maximum performance (max. ergometric performance)
Time frame: 12 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 12 Mar 2009.
- Background: PubMed 11788102Ainsworth BE, Anderson LA, Becker DM, Blalock SJ, Brown DR, Brownson RC, Brownstein N, Cornell CE, Devellis BM, Finnegan LP, Folger S, Fulton JE, Groff JY, Herman C, Jones D, Keyserling TC, Matson Koffman D, Lewis C, Masse LC, McKeown RE, Orenstein D, Spadaro AJ; Women's Health Initiative Community Prevention Study Collaborators. Observations from the CDC. Community Prevention Study: contributions to women's health and prevention research. J Womens Health Gend Based Med. 2001 Dec;10(10):913-20. doi: 10.1089/152460901317193495. No abstract available.
- BackgroundBullinger M, Kirchberger I. SF-36. Fragebogen zum Gesundheitszustand. Göttingen, Hogrefe 1998
- BackgroundCenters for disease control. Overweight and obesity. www.cdc.gov/nccdphp/dnpa/obesity/trend/maps/index.htm
- BackgroundChisholm DM, Collis ML, Kulak LL, Davenport W, Gruber N. Physical activity readiness. Br Col Med J 17(1975);375-78
- BackgroundDeutsches Netzwerk für Betriebliche Gesundheitsförderung. www.dnbgf.de
- Background: PubMed 10407953Frey I, Berg A, Grathwohl D, Keul J. [Freiburg Questionnaire of physical activity--development, evaluation and application]. Soz Praventivmed. 1999;44(2):55-64. doi: 10.1007/BF01667127. German.
- Background: PubMed 17762377Haskell WL, Lee IM, Pate RR, Powell KE, Blair SN, Franklin BA, Macera CA, Heath GW, Thompson PD, Bauman A. Physical activity and public health: updated recommendation for adults from the American College of Sports Medicine and the American Heart Association. Med Sci Sports Exerc. 2007 Aug;39(8):1423-34. doi: 10.1249/mss.0b013e3180616b27.
- Background: PubMed 17972028Konig D, Bonner G, Berg A. [The role of adiposity and inactivity in primary prevention of cardiovascular disease]. Herz. 2007 Oct;32(7):553-9. doi: 10.1007/s00059-007-3019-7. German.
- BackgroundNationale Verzehrstudie II. Bundesministerium für Ernährung, Landwirtschaft, und Verbraucherschutz. www.was-esse-ich.de
- Background: PubMed 5556752Parizkova J, Buzkova P. Relationship between skinfold thickness measured by Harpenden caliper and densitometric analysis of total body fat in men. Hum Biol. 1971 Feb;43(1):16-21. No abstract available.
- BackgroundStatistisches Bundesamt. www.destatis.de
- Background: PubMed 15983307Sullivan PW, Morrato EH, Ghushchyan V, Wyatt HR, Hill JO. Obesity, inactivity, and the prevalence of diabetes and diabetes-related cardiovascular comorbidities in the U.S., 2000-2002. Diabetes Care. 2005 Jul;28(7):1599-603. doi: 10.2337/diacare.28.7.1599.
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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.
Martin Halle, P.D. principal investigator
Department of Sports Medicine, Klinikum rechts der Isar, Technical University of Munich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined 3-monthly endurance and strength training in people with Metabolic Syndrome, run by Technical University of Munich 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 6 inclusion and 6 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 12 Mar 2009. 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?
Evaluation of the effect of a combined personal and IT- based training on the performance at the metabolic anaerobe barrier of patients with impending or manifest metabolic syndrome compared to a control group with conventional consulting (time frame: 12 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 NCT00686244, which also lists 14 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 12 Mar 2009.