IT-Based Training in Metabolic Syndrome (SPRINT)
11 mars 2009 uppdaterad av: Technical University of Munich
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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Förväntat)
125
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Munich, Tyskland, 80809
- Lehrstuhl für Praeventive und Rehabilitative Sportmedizin Klinikum Rechts der Isar, Technical University of Munich
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
20 år till 60 år (Vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- 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)
Exclusion Criteria:
- > 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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: Training Group
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 |
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 |
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Inget ingripande: Control Group
No guided training.
Exercise optional after detailed consulting and handing over an information dossier for adequate physical activity.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
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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
Tidsram: 12 months
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12 months
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Sekundära resultatmått
Resultatmått |
Tidsram |
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Evaluation of the effect of IT based training on metabolic parameters
Tidsram: 12 months
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12 months
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Evaluation of the efficacy of IT based training to an increase of activity by patients with impending or manifest metabolic syndrome
Tidsram: 12 months
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12 months
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Change in quality of life and subjective assumption of health sensation
Tidsram: 12 months
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12 months
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Change in anthropometric parameters
Tidsram: 12 months
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12 months
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Raise of maximum performance (max. ergometric performance)
Tidsram: 12 months
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12 months
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Martin Halle, P.D., Department of Sports Medicine, Klinikum rechts der Isar, Technical University of Munich
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- Haskell 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.
- Graham 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.
- 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.
- Bullinger 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.
- Konig 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.
- Nationale 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.
- Statistisches 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.
- Vatten 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 april 2008
Primärt slutförande (Faktisk)
1 mars 2009
Avslutad studie (Faktisk)
1 mars 2009
Studieregistreringsdatum
Först inskickad
21 maj 2008
Först inskickad som uppfyllde QC-kriterierna
28 maj 2008
Första postat (Uppskatta)
29 maj 2008
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
12 mars 2009
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
11 mars 2009
Senast verifierad
1 mars 2009
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- FKZ01FD0609
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