IT-Based Training in Metabolic Syndrome (SPRINT)

March 11, 2009 updated by: 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

125

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Munich, Germany, 80809
        • Lehrstuhl für Praeventive und Rehabilitative Sportmedizin Klinikum Rechts der Isar, Technical University of Munich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluation of the effect of IT based training on metabolic parameters
Time Frame: 12 months
12 months
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
12 months
Change in quality of life and subjective assumption of health sensation
Time Frame: 12 months
12 months
Change in anthropometric parameters
Time Frame: 12 months
12 months
Raise of maximum performance (max. ergometric performance)
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technical University of Munich

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

May 21, 2008

First Submitted That Met QC Criteria

May 28, 2008

First Posted (Estimate)

May 29, 2008

Study Record Updates

Last Update Posted (Estimate)

March 12, 2009

Last Update Submitted That Met QC Criteria

March 11, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FKZ01FD0609

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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