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

November 5, 2011 updated by: Andree Hillebrecht, University of Giessen

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

68

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
    • Hessen
      • Giessen, Hessen, Germany, 35394
        • University of Gießen
    • Sachsen
      • Zwickau, Sachsen, Germany, 08056
        • Sportpark Zwickau, Glauchau, Meerane

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
alteration of HbA1c-level (haemoglobin A1c)
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
alteration of total cholesterol level
Time Frame: 6 months
6 months
alteration of LDL-cholesterol-level
Time Frame: 6 months
6 months
alteration of HDL-cholesterol-level
Time Frame: 6 months
6 months
alteration of triglyceride-level
Time Frame: 6 months
6 months
alteration of antidiabetic medications
Time Frame: 6 months
6 months
alteration of anthropometry
Time Frame: 6 months
body weight; body mass index; hip-to-waist-ratio
6 months
alteration of body composition
Time Frame: 6 months
measured by Bio-impedance analysis
6 months
alteration of resting metabolic rate
Time Frame: 6 months
  1. measured by Spirometrie (Cortex metamax)
  2. calculated by Bio-impedance analysis (TANITA)
6 months
alteration of blood pressure
Time Frame: 6 months
6 months
alteration of cardiac and pulmonary capacity
Time Frame: 6 months
  1. measured by ergometry
  2. six-minutes walk test
6 months
alteration of quality of life
Time Frame: 6 months
6 months
follow up of all parameters mentioned above
Time Frame: 15 months
follow up after 15 months without any supervised intervention
15 months

Collaborators and Investigators

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

Sponsor

University of Giessen

Collaborators

Comenius University
Sportpark Zwickau, Germany
Sportpark Glauchau, Germany

Investigators

  • Study Chair: Andree Hillebrecht, Dr. med., University of Gießen
  • Study Director: Dusan Hamar, Prof. Dr., Comenius University

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

February 1, 2010

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

July 12, 2011

First Submitted That Met QC Criteria

July 12, 2011

First Posted (Estimate)

July 13, 2011

Study Record Updates

Last Update Posted (Estimate)

November 8, 2011

Last Update Submitted That Met QC Criteria

November 5, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Gi-01-2010

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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