Clinical trial NCT01393275: Effects of Exercise Intervention and Rehabilitation Exercise Intervention in Patients With Type 2 Diabetes
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Diabetes Mellitus, Non-Insulin-Dependent
Keywords: diabetes
exercise
intervention
rehabilitation
metabolic rate
sport
Lead sponsor: University of Giessen
Sponsor class: OTHER
Collaborators: name: Sportpark Zwickau, Germany
name: Sportpark Glauchau, Germany
name: Comenius University
First posted: 2011-07-13
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: alteration of HbA1c-level (haemoglobin A1c)
timeFrame: 6 months
Secondary outcomes:
measure: alteration of total cholesterol level
timeFrame: 6 months
measure: alteration of LDL-cholesterol-level
timeFrame: 6 months
measure: alteration of HDL-cholesterol-level
timeFrame: 6 months
measure: alteration of triglyceride-level
timeFrame: 6 months
measure: alteration of antidiabetic medications
timeFrame: 6 months
measure: alteration of anthropometry
timeFrame: 6 months
measure: alteration of body composition
timeFrame: 6 months
measure: alteration of resting metabolic rate
timeFrame: 6 months
measure: alteration of blood pressure
timeFrame: 6 months
measure: alteration of cardiac and pulmonary capacity
timeFrame: 6 months
measure: alteration of quality of life
timeFrame: 6 months
measure: follow up of all parameters mentioned above
timeFrame: 15 months
Other outcomes:
Locations:
city: Giessen
country: Germany
facility: University of Giessen
state: Hessen
city: Zwickau
country: Germany
facility: Sportpark Zwickau, Glauchau, Meerane
state: Sachsen
Study officials:
affiliation: University of Giessen
name: Andree Hillebrecht, Dr. med.
role: STUDY_CHAIR
affiliation: Comenius University
name: Dusan Hamar, Prof. Dr.
role: STUDY_DIRECTOR
References: