IT-Based Training in Metabolic Syndrome

Metabolic Syndrome Clinical Trial

— SPRINT  

Official title:

Effect of Personal and IT Based Training to Performance, Metabolic Profil and Quality of Life by Patients With Metabolic Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00686244
• Other study ID #: FKZ01FD0609
• Status: Completed
• Phase: N/A
• First received: May 21, 2008
• Last updated: March 11, 2009
• Start date: April 2008
• Est. completion date: March 2009

Study information

• Verified date: March 2009
• Source: Technische Universität München
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Ministry of Education and Research
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

Intervention

Other:
• Combined 3-monthly endurance and strength training
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

Locations

Country	Name	City	State
Germany	Lehrstuhl für Praeventive und Rehabilitative Sportmedizin Klinikum Rechts der Isar, Technical University of Munich	Munich

Sponsors (2)

Lead Sponsor	Collaborator
Technische Universität München	German Federal Ministry of Education and Research

Country where clinical trial is conducted

Germany, 

References & Publications (10)

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, Mâsse 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. Review. — View Citation

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

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

Frey I, Berg A, Grathwohl D, Keul J. [Freiburg Questionnaire of physical activity--development, evaluation and application]. Soz Praventivmed. 1999;44(2):55-64. German. — View Citation

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, Tokgözoglu 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. — View Citation

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. — View Citation

König D, Bönner G, Berg A. [The role of adiposity and inactivity in primary prevention of cardiovascular disease]. Herz. 2007 Oct;32(7):553-9. Review. German. — View Citation

Parízková J, Buzková 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. — View Citation

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. — View Citation

Vatten LJ, Nilsen TI, Romundstad PR, Drøyvold WB, Holmen J. Adiposity and physical activity as predictors of cardiovascular mortality. Eur J Cardiovasc Prev Rehabil. 2006 Dec;13(6):909-15. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Evaluation of the effect of IT based training on metabolic parameters		12 months	No
Secondary	Evaluation of the efficacy of IT based training to an increase of activity by patients with impending or manifest metabolic syndrome		12 months	No
Secondary	Change in quality of life and subjective assumption of health sensation		12 months	No
Secondary	Change in anthropometric parameters		12 months	No
Secondary	Raise of maximum performance (max. ergometric performance)		12 months	No