IT-Based Training in Metabolic Syndrome (SPRINT)
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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 |
- 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 ]
- 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 |
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| Germany | |
| Lehrstuhl für Praeventive und Rehabilitative Sportmedizin Klinikum Rechts der Isar, Technical University of Munich | |
| Munich, Germany, 80809 | |
| Principal Investigator: | Martin Halle, P.D. | Department of Sports Medicine, Klinikum rechts der Isar, Technical University of Munich |
More Information
Publications:
| 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 May 23, 2013