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Effects of Exercise Intervention and Rehabilitation Exercise Intervention in Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Collaborators:
Sportpark Zwickau, Germany
Sportpark Glauchau, Germany
Comenius University
Information provided by (Responsible Party):
Andree Hillebrecht, University of Giessen
ClinicalTrials.gov Identifier:
NCT01393275
First received: July 12, 2011
Last updated: November 5, 2011
Last verified: November 2011

July 12, 2011
November 5, 2011
February 2010
November 2010   (final data collection date for primary outcome measure)
alteration of HbA1c-level (haemoglobin A1c) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01393275 on ClinicalTrials.gov Archive Site
  • alteration of total cholesterol level [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • alteration of LDL-cholesterol-level [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • alteration of HDL-cholesterol-level [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • alteration of triglyceride-level [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • alteration of antidiabetic medications [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • alteration of anthropometry [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    body weight; body mass index; hip-to-waist-ratio
  • alteration of body composition [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    measured by Bio-impedance analysis
  • alteration of resting metabolic rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    1. measured by Spirometrie (Cortex metamax)
    2. calculated by Bio-impedance analysis (TANITA)
  • alteration of blood pressure [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • alteration of cardiac and pulmonary capacity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    1. measured by ergometry
    2. six-minutes walk test
  • alteration of quality of life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • follow up of all parameters mentioned above [ Time Frame: 15 months ] [ Designated as safety issue: No ]
    follow up after 15 months without any supervised intervention
Same as current
Not Provided
Not Provided
 
Effects of Exercise Intervention and Rehabilitation Exercise Intervention in Patients With Type 2 Diabetes
Effects of Exercise Intervention in Patients With Type 2 Diabetes - Strength Endurance Exercise Intervention Versus Combination of Strength Endurance Exercise Intervention and Rehabilitation Exercise Intervention

The purposes of the study are

  • to determine if a supervised exercise intervention is improving the metabolic parameters in type 2 diabetes patients
  • to investigate what kind of intervention (strength endurance training versus combined strength endurance training and rehabilitation exercise intervention)is more effective in improving the metabolic parameters in patients with type 2 diabetes
  • to assess which exercise intervention induces higher effects to the metabolic rate and cardiac and pulmonary capacity
  • to investigate what kind of intervention includes highest effects in long term persistence of these positive effects
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Non-Insulin-Dependent
  • Other: rehabilitation exercise intervention

    exercise intervention: 15 minutes warm up, 30 minutes strength endurance training, 60 minutes rehabilitation exercise training - once a week

    15 minutes warm up, 30 minutes strength endurance training - once a week

  • Other: placebo control group

    exercise intervention: 15 minutes warm up, 30 minutes strength endurance training, 5 minutes walking 55 minutes conversation in the group- once a week

    15 minutes warm up, 30 minutes strength endurance training - once a week

  • Active Comparator: Rehabilitation intervention group
    The group is performing a strength endurance training intervention in addition with rehabilitation exercise intervention.
    Intervention: Other: rehabilitation exercise intervention
  • Placebo Comparator: Placebo rehabilitation
    The group is performing a strength endurance training intervention in addition with placebo rehabilitation exercise intervention.
    Intervention: Other: placebo control group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
68
October 2011
November 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • diagnosis of type 2 diabetes (ADA criteria)
  • admitted diabetes treatment will be diet and oral hypoglycemic agents

Exclusion Criteria:

  • sports intervention > 60 minutes per week

medical conditions

  • proliferative retinopathy
  • instable coronary heart disease
  • acute clinically significant intercurrent disease
  • inability to perform scheduled physical activity programs
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01393275
Gi-01-2010
No
Andree Hillebrecht, University of Giessen
University of Giessen
  • Sportpark Zwickau, Germany
  • Sportpark Glauchau, Germany
  • Comenius University
Study Chair: Andree Hillebrecht, Dr. med. Justus-Liebig-University Giessen
Study Director: Dusan Hamar, Prof. Dr. Comenius University
University of Giessen
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP