Intensity of Exercise and Glucose Metabolism (PreDiabEx)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
- Glucose and lipid metabolism [ Time Frame: 3-month intervention ] [ Designated as safety issue: Yes ]
- Changes in muscle metabolism [ Time Frame: 3-months intervention ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2010|
|Estimated Study Completion Date:||June 2013|
|Primary Completion Date:||June 2010 (Final data collection date for primary outcome measure)|
Experimental: Exercise intervention
3-month supervised exercise intervention 3 times per week; 60min per time.
No Intervention: No intervention
Standard couselling at baseline
Study type: Interventional
Study design: Randomized
Endpoint classification: Changes in fasting and 2 h glucose, insulin and lipid concentrations
Intervention model: Parallel assignment
Masking: Open label
Primary purpose: Prevention and dose response assessment of exercise on glucose and lipid metabolism
Intervention: Supervised exercise - The training sessions of the intervention group are carried out indoors 3 times a week for 3 months and supervised by an exercise instructor and physician. Each session last for 60 min and include a 5-min warm-up and stretching, a 20-min walking at speeds 2-4 km/h depending of the participant's physical condition, a 5-min stretching and balance training, a 20-min walking, and a 10-min stretching and balance training. After 1.5 months the 5-min stretching and balance training between the two 20-min walkings is excluded, and the walking time become 45 min.
No intervention: control group; couseling at baseline. Participants of the control group are advised to continue their usual physical and dietary habits.
Experimental: 1 -supervised exercise intervention. No intervention: 2 - standard counseling at baseline.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01649219
|University of Oulu|
|Oulu, Finland, 90014|
|Principal Investigator:||Karl-Heinz Herzig, MD,PhD||University of Oulu|