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

Study Overview
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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

Official Title
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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

Conditions
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Diabetes, Diabetes Mellitus, Non-Insulin-Dependent

Intervention / Treatment
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* Other: rehabilitation exercise intervention
* Other: placebo control group


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Rehabilitation intervention group<br>The group is performing a strength endurance training intervention in addition with rehabilitation exercise intervention. | Other: rehabilitation exercise intervention<br>* 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<br>|
| Placebo Comparator: Placebo rehabilitation<br>The group is performing a strength endurance training intervention in addition with placebo rehabilitation exercise intervention. | Other: placebo control group<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes, exercise, intervention, rehabilitation, metabolic rate, sport