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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
History of Changes
  Purpose

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

Condition Intervention
Diabetes
Diabetes Mellitus, Non-Insulin-Dependent
 Other: rehabilitation exercise intervention
Other: placebo control group

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Giessen:

Primary Outcome Measures:
  • alteration of HbA1c-level (haemoglobin A1c) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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


Enrollment: 68
Study Start Date: February 2010
Study Completion Date: October 2011
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Rehabilitation intervention group
The group is performing a strength endurance training intervention in addition with rehabilitation exercise intervention.
 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
Placebo Comparator: Placebo rehabilitation
The group is performing a strength endurance training intervention in addition with placebo rehabilitation exercise intervention.
 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01393275

Locations
Germany
University of Giessen
Giessen, Hessen, Germany, 35394
Sportpark Zwickau, Glauchau, Meerane
Zwickau, Sachsen, Germany, 08056
Sponsors and Collaborators
University of Giessen
Sportpark Zwickau, Germany
Sportpark Glauchau, Germany
Comenius University
Investigators
Study Chair: Andree Hillebrecht, Dr. med. Justus-Liebig University Giessen
Study Director: Dusan Hamar, Prof. Dr. Comenius University
  More Information

No publications provided

Responsible Party: Andree Hillebrecht, Akad. Rat, University of Giessen
ClinicalTrials.gov Identifier: NCT01393275     History of Changes
Other Study ID Numbers: Gi-01-2010
Study First Received: July 12, 2011
Last Updated: November 5, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by University of Giessen:
diabetes
exercise
intervention
 rehabilitation
metabolic rate
sport

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 21, 2013