IT-Based Training in Metabolic Syndrome (SPRINT)

This study has been completed.
Sponsor:
Collaborator:
German Federal Ministry of Education and Research
Information provided by:
Technische Universität München
ClinicalTrials.gov Identifier:
NCT00686244
First received: May 21, 2008
Last updated: March 11, 2009
Last verified: March 2009
  Purpose

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.


Condition Intervention
Metabolic Syndrome
Other: Combined 3-monthly endurance and strength training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Effect of Personal and IT Based Training to Performance, Metabolic Profil and Quality of Life by Patients With Metabolic Syndrome

Resource links provided by NLM:


Further study details as provided by Technische Universität München:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluation of the effect of IT based training on metabolic parameters [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change in quality of life and subjective assumption of health sensation [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change in anthropometric parameters [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Raise of maximum performance (max. ergometric performance) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 125
Study Start Date: April 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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

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

No Intervention: Control Group
No guided training. Exercise optional after detailed consulting and handing over an information dossier for adequate physical activity.

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.

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00686244

Locations
Germany
Lehrstuhl für Praeventive und Rehabilitative Sportmedizin Klinikum Rechts der Isar, Technical University of Munich
Munich, Germany, 80809
Sponsors and Collaborators
Technische Universität München
German Federal Ministry of Education and Research
Investigators
Principal Investigator: Martin Halle, P.D. Department of Sports Medicine, Klinikum rechts der Isar, Technical University of Munich
  More Information

Publications:
Chisholm DM, Collis ML, Kulak LL, Davenport W, Gruber N. Physical activity readiness. Br Col Med J 17(1975);375-78
Graham I et al. European guidelines on cardiovascular disease prevention in clinical practice: executive summary. Eur J Cardiovas Prev Rehabil 2007;14 Suppl 2:E1-40

Responsible Party: Martin Halle, Ph.D., Department of Sports Medicine, Klinikum rechts der Isar, Technical University of Munich
ClinicalTrials.gov Identifier: NCT00686244     History of Changes
Other Study ID Numbers: FKZ01FD0609
Study First Received: May 21, 2008
Last Updated: March 11, 2009
Health Authority: Germany: Federal Ministry of Education and Research

Keywords provided by Technische Universität München:
metabolic syndrome
physical activity
overweight
malnutrition
prevention

Additional relevant MeSH terms:
Metabolic Syndrome X
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on July 29, 2014