Supervised Walking Groups as a Model to Increase Physical Activity in Type 2 Diabetes
|Type 2 Diabetes||Behavioral: Supervised walking Behavioral: Standard counselling procedure|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Assessment of Feasibility and Efficacy of a Project Aimed to Improve Metabolic Control in Type 2 Diabetes Through Lifestyle Changes and Self-monitoring of Blood Glucose|
- Change in haemoglobin A1c (HbA1c) levels [ Time Frame: 4 months ]The measurement of HbA1c is carried out with a DCCT-aligned method.
- Change in Body weight [ Time Frame: 4 months ]
- Change in Fasting plasma glucose levels [ Time Frame: 4 months ]
- Change in Total Cholesterol levels [ Time Frame: 4 months ]
- Change in HDL Cholesterol levels [ Time Frame: 4 months ]
- Change in LDL Cholesterol levels [ Time Frame: 4 months ]
- Change in Triglycerides levels [ Time Frame: 4 months ]
- Change in Blood Pressure [ Time Frame: 4 months ]
- Change in 6 minutes walk distance [ Time Frame: 4 months ]This test measures the number of meters that can be walked in 6 minutes over a 30 m course. It is a simple field test to assess aerobic functional capacity.
- Change in C-reactive protein levels [ Time Frame: 4 months ]
- Change in Energy expenditure through voluntary physical activity [ Time Frame: 4 months ]Energy expenditure is estimated through 7-day activity diaries. The intensity of each activity (defined in metabolic equivalents, MET) is multiplied by duration and the product for each activity is summed to give a total activity score in MET hours/week.
- Change in Antidiabetic medications [ Time Frame: 4 months ]Class and dosage of blood-glucose lowering drugs are recorded before and at the end of the protocol, to assess changes in hypoglycemic medication during the trial.
- Compliance with walking sessions [ Time Frame: 4 months ]Attendance at the scheduled walking sessions is recorded for each patient.
|Study Start Date:||March 2006|
|Study Completion Date:||January 2009|
|Primary Completion Date:||January 2008 (Final data collection date for primary outcome measure)|
Experimental: Supervised walking groups
Patients included in walking groups, under the supervision of a qualified personal trainer.
Behavioral: Supervised walking
Walk training, 3 sessions per week for 4 months, under the supervision of a qualified personal trainer.
Active Comparator: Controls
Patients receiving the standard counselling procedures of the Verona Diabetic Clinic.
Behavioral: Standard counselling procedure
Verbal and written information about the benefits of exercise and instructions aimed to encourage physical activity. In addition, one group session of counselling on these issues.
Regular, moderate-intensity physical activity can attenuate hyperglycemia in subjects with type 2 diabetes. In addition, these programmes may favourably affect several other cardiovascular risk factors in these subjects. However, it still remains unclear how this evidence can be transferred into clinical practice, considering the very large number of diabetic patients and the characteristics of this population, made up predominantly of elderly, sedentary and overweight patients. In this regard, a realistic approach to this issue requires simple and easily available intervention models.
Walking is a typical mild-moderate aerobic physical activity which is easy to organize and does not require specific skills or preliminary sophisticated medical evaluations. This activity could therefore fit well with the need of involvement of large numbers of patients in different logistic situations. However, it has been reported that, due to the low walking speed typical of type 2 diabetic subjects, self-paced walking is inadequate to obtain a significant metabolic improvement in these subjects.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01115205
|Principal Investigator:||Paolo Moghetti, M.D., Ph.D.||Universita di Verona|