Effects of Different Types of Exercise Interventions in Patients With Type 2 Diabetes

Effects of Different Types of Exercise Interventions in Patients With Type 2 Diabetes - Aerobic Endurance Training Versus Strength Endurance Training Versus Combined Aerobic Endurance and Strength Endurance Training -

The purposes of the study are

• to determine which kind of supervised exercise intervention (aerobic endurance training versus strength endurance training versus combined aerobic endurance and strength endurance training) is more effective in improving the metabolic parameters in typ 2 diabetes patients
• to investigate what kind of intervention is more successful in reduction of concomitant diseases and improving quality of life
• to assess what kind of intervention induces highest effects in long term persistence of these positive changes

Study Overview

• Status: Unknown
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Other: Aerobic endurance training intervention; Other: Strength endurance training intervention; Other: Combined aerobic endurance and strength endurance training

Detailed Description

Meta-analyses which evaluated the effects of structured exercise programs in patients with type 2 diabetes demonstrate that regular physical activity improves glycosylated haemoglobin (König et al.: Resistance Exercise and Type 2 Diabetes Mellitus, Deutsche Zeitschrift für Sportmedizin Jahrgang 62, Nr. 1 (2011): 5-9). Sigal et al. proved that either aerobic or resistance training alone improved glycemic control in type 2 diabetes, but the improvements are greatest with combined aerobic and resistance training (Sigal, RJ, et al.: Effects of Aerobic Training, Resistance Training, or Both on Glycemic Control in Type 2 Diabetes, Ann Intern Med. 2007 Sep 18;147(6):357-69).

Therefore, aim of the current study is to compare the effects of aerobic endurance training or resistance endurance training or the combination of aerobic endurance training and resistance endurance training in diabetes type 2 patients without any other lifestyle or dietary interventions.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Hessen
    • Giessen, Hessen, Germany, 35394
      • University of Gießen
  • Sachsen
    • Zwickau, Sachsen, Germany, 08056
      • Sportpark Zwickau, Glauchau, Meerane

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• diagnoses of type 2 diabetes (ADA criteria)
• admitted diabetes treatments will be diet and oral hypoglycemic agents

Exclusion Criteria:

• sports intervention >60 minutes per week
• medical conditions
• preproliferative or proliferative retinopathy
• instable coronary heart disease
• inability to perform the scheduled physical activity programs
• acute clinically significant intercurrent diseases

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Aerobic endurance training intervention; Aerobic endurance training	Other: Aerobic endurance training intervention; The aerobic endurance training group will use cardiovascular training devices week 1-4: 15 minutes warm up (group) 15 minutes intervention at 80-100% vAT two times per week week 5-13: 15 minutes warm up (group) 30 minutes intervention at 95-110% vAT two times per week week 14-26: 15 minutes warm up (group) 45 minutes intervention at 95-110% vAT two times per week; Other Names: aerobic endurance training
Experimental: Strength endurance training intervention; Strength endurance training	Other: Strength endurance training intervention; The strength endurance training intervention group will perform eight exercises on weight machines (Milon circuit training- 60 seconds activity, 30 seconds break) week 1-4: 15 minutes warm up (group) 1 session resistance training intensity 3 (Buskies) two times per week week 5-13: 15 minutes warm up (group) 2 sessions resistance training intensity 5 (Buskies) two times per week week 14-26: 15 minutes warm up (group) 3 sessions resistance training intensity 5 (Buskies) two times per week; Other Names: Strength endurance training
Experimental: Combined training intervention; Combined aerobic endurance training and strength endurance training intervention	Other: Combined aerobic endurance and strength endurance training; week 1-4: 15 minutes warm up (group) 15 minutes intervention at 80-100% vAT once per week and 15 minutes warm up (group) 1 session resistance training intensity 3 (Buskies) once per week week 5-13: 15 minutes warm up (group) 15 minutes intervention at 95-110% vAT and 1 session resistance training intensity 5 (Buskies) two times per week week 14-26: 15 minutes warm up (group) 30 minutes intervention at 95-110% vAT and 1 session resistance training intensity 5 (Buskies) once a week and 15 minutes warm up (group) 15 minutes intervention at 95-110% vAT and 2 sessions resistance training intensity 5 (Buskies) once a week
No Intervention: Control group; control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in HbA1c-level (haemoglobin A1c)	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in HOMA-Index		3 and 6 months
Change in beta-cell-function	Measured by OGTT (Oral Glucose Tolerance Test)	3 and 6 months
Change in fasting plasma glucose levels		3 and 6 months
Change in total cholesterol levels		3 and 6 months
Change in HDL-cholesterol levels		3 and 6 months
Change in LDL-cholesterol levels		3 and 6 months
Change in triglyceride levels		3 and 6 months
Change in antidiabetic medications	Class and dosage of blood-glucose lowering drugs are recorded before, after 3 and 6 months	3 and 6 months
Change in inflammation markers	CrP, blood count, interleukinstatus, cytokinstatus	3 and 6 months
Change in body weight		3 and 6 months
Change in body composition	by Bio-impedance analysis, waist to hip ratio, range of thigh	3 and 6 months
Change in strength	by Dr. Wolff Back Check	3 and 6 months
Change of maximum heart rate	Measured by an incremental exercise test	3 and 6 months
Change of peak oxygen uptake	Measured by an incremental exercise test	3 and 6 months
Change of vAT (ventilatory anaerobic threshold)	Measured by an incremental exercise test	3 and 6 months
Change in blood pressure		3 and 6 months
Change in renal function	Creatininlevel, Albuminlevel (urine), Telomere length	3 and 6 months
Change in concentration	by d2-test	3 and 6 months
Change in quality of life	by questionnaire: SF-12, EQ5	3 and 6 months
Change of nutrition	by questionnaire: FEV, FFQ	3 and 6 months
Change in voluntary physical activity	meassured by pedometer (one week)	3 and 6 months
Change of cardiac output by Impedance cardiography	by Task Force Monitor	3 and 6 months
Change of barorezeptorsensitivity	by Task Force Monitor	3 and 6 months
Change in carotid-Intima-Media-Thickness		3 and 6 months
Change in aortic pulse-wave velocity		3 and 6 months
Change in central aortic pressure		3 and 6 month
Change in endothelial dysfunction		3 and 6 months
Change of parodontitis		3 and 6 months
Follow up of all parameters mentioned above	Follow up after 12 months (6 months after completing the exercise intervention) without any supervised intervention	after 12 months

Collaborators and Investigators

• Sponsor: University of Giessen
• Collaborators: Hannover Medical School
• Investigators: Principal Investigator: Andree Hillebrecht, Dr. med., University of Gießen

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Anticipated): November 1, 2011
• Study Completion (Anticipated): June 1, 2012

Study Registration Dates

• First Submitted: June 9, 2011
• First Submitted That Met QC Criteria: June 20, 2011
• First Posted (Estimate): June 21, 2011

Study Record Updates

• Last Update Posted (Estimate): June 23, 2011
• Last Update Submitted That Met QC Criteria: June 22, 2011
• Last Verified: April 1, 2011

More Information

Terms related to this study

• Keywords: diabetes; HbA1c; endothelial dysfunction; type 2 diabetes; training; resistance training; aerobic training; Exercise intervention; combination of aerobic and resistance training; inflammation markers; Parodontitis
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: Gi-03-2011