Supervised Walking Groups as a Model to Increase Physical Activity in Type 2 Diabetes
Primary Purpose
Type 2 Diabetes
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Supervised walking
Standard counselling procedure
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes focused on measuring Exercise, Walking, Type 2 diabetes, Therapy
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Supervised walking groups
Controls
Arm Description
Patients included in walking groups, under the supervision of a qualified personal trainer.
Patients receiving the standard counselling procedures of the Verona Diabetic Clinic.
Outcomes
Primary Outcome Measures
Change in haemoglobin A1c (HbA1c) levels
The measurement of HbA1c is carried out with a DCCT-aligned method.
Secondary Outcome Measures
Change in Body weight
Change in Fasting plasma glucose levels
Change in Total Cholesterol levels
Change in HDL Cholesterol levels
Change in LDL Cholesterol levels
Change in Triglycerides levels
Change in Blood Pressure
Change in 6 minutes walk distance
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
Change in Energy expenditure through voluntary physical activity
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
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
Attendance at the scheduled walking sessions is recorded for each patient.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01115205
Brief Title
Supervised Walking Groups as a Model to Increase Physical Activity in Type 2 Diabetes
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Universita di Verona
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Exercise, Walking, Type 2 diabetes, Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
59 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Supervised walking groups
Arm Type
Experimental
Arm Description
Patients included in walking groups, under the supervision of a qualified personal trainer.
Arm Title
Controls
Arm Type
Active Comparator
Arm Description
Patients receiving the standard counselling procedures of the Verona Diabetic Clinic.
Intervention Type
Behavioral
Intervention Name(s)
Supervised walking
Intervention Description
Walk training, 3 sessions per week for 4 months, under the supervision of a qualified personal trainer.
Intervention Type
Behavioral
Intervention Name(s)
Standard counselling procedure
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in haemoglobin A1c (HbA1c) levels
Description
The measurement of HbA1c is carried out with a DCCT-aligned method.
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Change in Body weight
Time Frame
4 months
Title
Change in Fasting plasma glucose levels
Time Frame
4 months
Title
Change in Total Cholesterol levels
Time Frame
4 months
Title
Change in HDL Cholesterol levels
Time Frame
4 months
Title
Change in LDL Cholesterol levels
Time Frame
4 months
Title
Change in Triglycerides levels
Time Frame
4 months
Title
Change in Blood Pressure
Time Frame
4 months
Title
Change in 6 minutes walk distance
Description
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.
Time Frame
4 months
Title
Change in C-reactive protein levels
Time Frame
4 months
Title
Change in Energy expenditure through voluntary physical activity
Description
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.
Time Frame
4 months
Title
Change in Antidiabetic medications
Description
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.
Time Frame
4 months
Title
Compliance with walking sessions
Description
Attendance at the scheduled walking sessions is recorded for each patient.
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paolo Moghetti, M.D., Ph.D.
Organizational Affiliation
Universita di Verona
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
20980426
Citation
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. doi: 10.2337/dc10-0877.
Results Reference
derived
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Supervised Walking Groups as a Model to Increase Physical Activity in Type 2 Diabetes
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