NCT00686244

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 21, 2008

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 29, 2008

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

March 12, 2009

Status Verified

March 1, 2009

Enrollment Period

11 months

First QC Date

May 21, 2008

Last Update Submit

March 11, 2009

Conditions

Metabolic Syndrome

Keywords

metabolic syndromephysical activityoverweightmalnutritionprevention

Outcome Measures

Primary Outcomes (1)

  • 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

    12 months

Secondary Outcomes (5)

  • Evaluation of the effect of IT based training on metabolic parameters

    12 months

  • Evaluation of the efficacy of IT based training to an increase of activity by patients with impending or manifest metabolic syndrome

    12 months

  • Change in quality of life and subjective assumption of health sensation

    12 months

  • Change in anthropometric parameters

    12 months

  • Raise of maximum performance (max. ergometric performance)

    12 months

Study Arms (2)

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

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.

Interventions

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

Training Group

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • \> 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lehrstuhl für Praeventive und Rehabilitative Sportmedizin Klinikum Rechts der Isar, Technical University of Munich

Munich, 80809, Germany

Location

Related Publications (14)

  • 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.

    PMID: 11788102BACKGROUND

  • Bullinger M, Kirchberger I. SF-36. Fragebogen zum Gesundheitszustand. Göttingen, Hogrefe 1998

    BACKGROUND

  • Centers for disease control. Overweight and obesity. www.cdc.gov/nccdphp/dnpa/obesity/trend/maps/index.htm

    BACKGROUND

  • Chisholm DM, Collis ML, Kulak LL, Davenport W, Gruber N. Physical activity readiness. Br Col Med J 17(1975);375-78

    BACKGROUND

  • Deutsches Netzwerk für Betriebliche Gesundheitsförderung. www.dnbgf.de

    BACKGROUND

  • 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.

    PMID: 10407953BACKGROUND

  • 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.

    PMID: 17762377BACKGROUND

  • 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.

    PMID: 17972028BACKGROUND

  • Nationale Verzehrstudie II. Bundesministerium für Ernährung, Landwirtschaft, und Verbraucherschutz. www.was-esse-ich.de

    BACKGROUND

  • 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.

    PMID: 5556752BACKGROUND

  • Statistisches Bundesamt. www.destatis.de

    BACKGROUND

  • 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.

    PMID: 15983307BACKGROUND

  • 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.

    PMID: 17143122BACKGROUND

  • 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.

    PMID: 17726406BACKGROUND

MeSH Terms

Conditions

Metabolic SyndromeMotor ActivityOverweightMalnutrition

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesBehaviorOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Martin Halle, P.D.

    Department of Sports Medicine, Klinikum rechts der Isar, Technical University of Munich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 21, 2008

First Posted

May 29, 2008

Study Start

April 1, 2008

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

March 12, 2009

Record last verified: 2009-03

Locations

DE(1)