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Completed

NCT Number: NCT01393275

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Giessen, Giessen, Hesse, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

rehabilitation exercise intervention

Other

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 control group

Other

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

Primary outcomes

  1. alteration of HbA1c-level (haemoglobin A1c)

    Time frame: 6 months

Secondary outcomes

  1. alteration of total cholesterol level

    Time frame: 6 months

  2. alteration of LDL-cholesterol-level

    Time frame: 6 months

  3. alteration of HDL-cholesterol-level

    Time frame: 6 months

  4. alteration of triglyceride-level

    Time frame: 6 months

  5. alteration of antidiabetic medications

    Time frame: 6 months

  6. alteration of anthropometry

    Time frame: 6 months

    body weight; body mass index; hip-to-waist-ratio

  7. alteration of body composition

    Time frame: 6 months

    measured by Bio-impedance analysis

  8. alteration of resting metabolic rate

    Time frame: 6 months

    • measured by Spirometrie (Cortex metamax)
    • calculated by Bio-impedance analysis (TANITA)
  9. alteration of blood pressure

    Time frame: 6 months

  10. alteration of cardiac and pulmonary capacity

    Time frame: 6 months

    • measured by ergometry
    • six-minutes walk test
  11. alteration of quality of life

    Time frame: 6 months

  12. follow up of all parameters mentioned above

    Time frame: 15 months

    follow up after 15 months without any supervised intervention

Sponsors and collaborators

Lead sponsor

University of Giessen

Other

Collaborators

  • Comenius University
  • Sportpark Glauchau, Germany
  • Sportpark Zwickau, Germany

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2010
Study completion
2011
First posted
Jul 13, 2011
Registry last updated
Nov 8, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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