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IT-Based Training in Metabolic Syndrome (SPRINT)

Primary Purpose

Metabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Combined 3-monthly endurance and strength training
Sponsored by
Technical University of Munich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Metabolic Syndrome focused on measuring metabolic syndrome, physical activity, overweight, malnutrition, prevention

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Training Group

Control Group

Arm Description

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 guided training. Exercise optional after detailed consulting and handing over an information dossier for adequate physical activity.

Outcomes

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

Secondary Outcome Measures

Evaluation of the effect of IT based training on metabolic parameters
Evaluation of the efficacy of IT based training to an increase of activity by patients with impending or manifest metabolic syndrome
Change in quality of life and subjective assumption of health sensation
Change in anthropometric parameters
Raise of maximum performance (max. ergometric performance)

Full Information

First Posted
May 21, 2008
Last Updated
March 11, 2009
Sponsor
Technical University of Munich
Collaborators
German Federal Ministry of Education and Research
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1. Study Identification

Unique Protocol Identification Number
NCT00686244
Brief Title
IT-Based Training in Metabolic Syndrome
Acronym
SPRINT
Official Title
Effect of Personal and IT Based Training to Performance, Metabolic Profil and Quality of Life by Patients With Metabolic Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Technical University of Munich
Collaborators
German Federal Ministry of Education and Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
Keywords
metabolic syndrome, physical activity, overweight, malnutrition, prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
125 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Training Group
Arm Type
Experimental
Arm Description
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
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
No guided training. Exercise optional after detailed consulting and handing over an information dossier for adequate physical activity.
Intervention Type
Other
Intervention Name(s)
Combined 3-monthly endurance and strength training
Intervention Description
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
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Evaluation of the effect of IT based training on metabolic parameters
Time Frame
12 months
Title
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
Title
Change in quality of life and subjective assumption of health sensation
Time Frame
12 months
Title
Change in anthropometric parameters
Time Frame
12 months
Title
Raise of maximum performance (max. ergometric performance)
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Halle, P.D.
Organizational Affiliation
Department of Sports Medicine, Klinikum rechts der Isar, Technical University of Munich
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lehrstuhl für Praeventive und Rehabilitative Sportmedizin Klinikum Rechts der Isar, Technical University of Munich
City
Munich
ZIP/Postal Code
80809
Country
Germany

12. IPD Sharing Statement

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IT-Based Training in Metabolic Syndrome

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