Supervised Walking Groups as a Model to Increase Physical Activity in Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Universita di Verona
ClinicalTrials.gov Identifier:
NCT01115205
First received: April 26, 2010
Last updated: May 3, 2010
Last verified: May 2010

April 26, 2010
May 3, 2010
March 2006
January 2008   (final data collection date for primary outcome measure)
Change in haemoglobin A1c (HbA1c) levels [ Time Frame: 4 months ] [ Designated as safety issue: No ]
The measurement of HbA1c is carried out with a DCCT-aligned method.
Change in haemoglobin A1c (HbA1c) levels [ Time Frame: 4 months ] [ Designated as safety issue: No ]
The measurement of HbA1c is considered the best test to determine the level of metabolic control of diabetes. HbA1c has greater preanalytical stability and is less subject to day-to-day perturbations than plasma glucose. In addition, it is strongly correlated with the risk of developing chronic complications of diabetes.
Complete list of historical versions of study NCT01115205 on ClinicalTrials.gov Archive Site
  • Change in Body weight [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Change in Fasting plasma glucose levels [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Change in Total Cholesterol levels [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Change in HDL Cholesterol levels [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Change in LDL Cholesterol levels [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Change in Triglycerides levels [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Change in Blood Pressure [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Change in 6 minutes walk distance [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Change in Energy expenditure through voluntary physical activity [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Attendance at the scheduled walking sessions is recorded for each patient.
  • Change in Body weight [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Change in Fasting plasma glucose levels [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Change in Total Cholesterol levels [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Change in HDL Cholesterol levels [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Change in LDL Cholesterol levels [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Change in Triglycerides levels [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Change in Blood Pressure [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Change in 6 minutes walk distance [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    This test measures the number of meters that can be walked in 6 minutes over a 30 m course. It is widely used and validated as a simple field test to assess aerobic functional capacity.
  • Change in C-reactive protein levels [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Change in Energy expenditure through voluntary physical activity [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Attendance at the scheduled walking sessions is recorded for each patient.
Not Provided
Not Provided
 
Supervised Walking Groups as a Model to Increase Physical Activity in Type 2 Diabetes
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

The purpose of the study is to evaluate the impact of an exercise programme organized into supervised walking groups on metabolic control, functional capacity and overall quantity of physical activity in subjects with type 2 diabetes.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 2 Diabetes
  • Behavioral: Supervised walking
    Walk training, 3 sessions per week for 4 months, under the supervision of a qualified personal trainer.
  • 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.
  • Experimental: Supervised walking groups
    Patients included in walking groups, under the supervision of a qualified personal trainer.
    Intervention: Behavioral: Supervised walking
  • Active Comparator: Controls
    Patients receiving the standard counselling procedures of the Verona Diabetic Clinic.
    Intervention: Behavioral: Standard counselling procedure
Negri C, Bacchi E, Morgante S, Soave D, Marques A, Menghini E, Muggeo M, Bonora E, Moghetti P. Supervised walking groups to increase physical activity in type 2 diabetic patients. Diabetes Care. 2010 Nov;33(11):2333-5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
59
January 2009
January 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • diabetes known for at least 2 yr
  • physical inactivity
  • haemoglobin (Hb)A1c between 6.5-9.9%
  • treatment with oral hypoglycaemic agents alone or associated with a bed-time insulin injection
  • willingness to participate in a programme of regular physical activity

Exclusion Criteria:

  • moderate-severe autonomic or somatic neuropathy
  • severe lower limb vasculopathy
  • pre-proliferative or proliferative active retinopathy
  • moderate to severe chronic renal failure
  • unstable angina or recent (in the previous 3 months) myocardial infarction
  • acute intercurrent diseases
  • acute metabolic decompensation (blood glucose >300 mg/dl or ketonuria in two consecutive checks)
  • use of beta-blocker drugs
  • subjects unable to complete a 6-min walk test
Both
50 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01115205
CE 1264
No
Paolo Moghetti, Department of Medicine, Universita di Verona
Universita di Verona
Not Provided
Principal Investigator: Paolo Moghetti, M.D., Ph.D. University of Verona
Universita di Verona
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP