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

NCT ID: NCT01393275

Last Updated: 2011-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2011-10-31

Brief Summary

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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

Detailed Description

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Conditions

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Diabetes Diabetes Mellitus, Non-Insulin-Dependent

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Rehabilitation intervention group

The group is performing a strength endurance training intervention in addition with rehabilitation exercise intervention.

Group Type ACTIVE_COMPARATOR

rehabilitation exercise intervention

Intervention Type 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 rehabilitation

The group is performing a strength endurance training intervention in addition with placebo rehabilitation exercise intervention.

Group Type PLACEBO_COMPARATOR

placebo control group

Intervention Type 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

Interventions

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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

Intervention Type 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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sportpark Zwickau, Germany

UNKNOWN

Sponsor Role collaborator

Sportpark Glauchau, Germany

UNKNOWN

Sponsor Role collaborator

Comenius University

OTHER

Sponsor Role collaborator

University of Giessen

OTHER

Sponsor Role lead

Responsible Party

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Andree Hillebrecht

Akad. Rat

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andree Hillebrecht, Dr. med.

Role: STUDY_CHAIR

University of Giessen

Dusan Hamar, Prof. Dr.

Role: STUDY_DIRECTOR

Comenius University

Locations

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University of Giessen

Giessen, Hesse, Germany

Site Status

Sportpark Zwickau, Glauchau, Meerane

Zwickau, Saxony, Germany

Site Status

Countries

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Germany

Other Identifiers

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Gi-01-2010

Identifier Type: -

Identifier Source: org_study_id