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

Not Applicable

Completed

• Conditions: Diabetes; Diabetes Mellitus, Non-Insulin-Dependent
• Interventions: Other: rehabilitation exercise intervention; Other: placebo control group

• Registration Number: NCT01393275
• Lead Sponsor: University of Giessen

Brief Summary

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

Not available

Study Timeline

• Study Start: 2010-02
• Primary Completion: 2010-11
• Study First Submitted: 2011-07-12
• Study First Submitted QC: 2011-07-12
• Study First Posted: 2011-07-13
• Study Completion: 2011-10
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-05
• Last Update Posted: 2011-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rehabilitation intervention group	rehabilitation exercise intervention	The group is performing a strength endurance training intervention in addition with rehabilitation exercise intervention.
Placebo rehabilitation	placebo control group	The group is performing a strength endurance training intervention in addition with placebo rehabilitation exercise intervention.

Primary Outcome Measures

Name	Time	Method
alteration of HbA1c-level (haemoglobin A1c)	6 months

Secondary Outcome Measures

Name	Time	Method
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	6 months	body weight; body mass index; hip-to-waist-ratio
alteration of body composition	6 months	measured by Bio-impedance analysis
alteration of resting metabolic rate	6 months	1. measured by Spirometrie (Cortex metamax); 2. calculated by Bio-impedance analysis (TANITA)
alteration of blood pressure	6 months
alteration of cardiac and pulmonary capacity	6 months	1. measured by ergometry; 2. six-minutes walk test
alteration of quality of life	6 months
follow up of all parameters mentioned above	15 months	follow up after 15 months without any supervised intervention

Trial Locations

Locations (2)

University of Giessen; 🇩🇪 Giessen, Hessen, Germany

Sportpark Zwickau, Glauchau, Meerane; 🇩🇪 Zwickau, Sachsen, Germany