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

Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01393275
• Other study ID #: Gi-01-2010
• Status: Completed
• Phase: N/A
• First received: July 12, 2011
• Last updated: November 5, 2011
• Start date: February 2010
• Est. completion date: October 2011

Study information

• Verified date: November 2011
• Source: University of Giessen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: October 2011
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Non-Insulin-Dependent
• Diabetes Mellitus, Type 2

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 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

Locations

Country	Name	City	State
Germany	University of Giessen	Giessen	Hessen
Germany	Sportpark Zwickau, Glauchau, Meerane	Zwickau	Sachsen

Sponsors (4)

Lead Sponsor	Collaborator
University of Giessen	Comenius University, Sportpark Glauchau, Germany, Sportpark Zwickau, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	alteration of HbA1c-level (haemoglobin A1c)		6 months	No
Secondary	alteration of total cholesterol level		6 months	No
Secondary	alteration of LDL-cholesterol-level		6 months	No
Secondary	alteration of HDL-cholesterol-level		6 months	No
Secondary	alteration of triglyceride-level		6 months	No
Secondary	alteration of antidiabetic medications		6 months	No
Secondary	alteration of anthropometry	body weight; body mass index; hip-to-waist-ratio	6 months	No
Secondary	alteration of body composition	measured by Bio-impedance analysis	6 months	No
Secondary	alteration of resting metabolic rate	measured by Spirometrie (Cortex metamax); calculated by Bio-impedance analysis (TANITA)	6 months	No
Secondary	alteration of blood pressure		6 months	No
Secondary	alteration of cardiac and pulmonary capacity	measured by ergometry; six-minutes walk test	6 months	No
Secondary	alteration of quality of life		6 months	No
Secondary	follow up of all parameters mentioned above	follow up after 15 months without any supervised intervention	15 months	No