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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
Universita di Verona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring Exercise, Walking, Type 2 diabetes, Therapy

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    April 26, 2010
    Last Updated
    May 3, 2010
    Sponsor
    Universita di Verona
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    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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