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
  Purpose

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.


Condition Intervention
Type 2 Diabetes
Behavioral: Supervised walking
Behavioral: Standard counselling procedure

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Universita di Verona:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 59
Study Start Date: March 2006
Study Completion Date: January 2009
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01115205

Sponsors and Collaborators
Universita di Verona
Investigators
Principal Investigator: Paolo Moghetti, M.D., Ph.D. Universita di Verona
  More Information

No publications provided by Universita di Verona

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Paolo Moghetti, Department of Medicine, Universita di Verona
ClinicalTrials.gov Identifier: NCT01115205     History of Changes
Other Study ID Numbers: CE 1264
Study First Received: April 26, 2010
Last Updated: May 3, 2010
Health Authority: Italy: Ethics Committee

Keywords provided by Universita di Verona:
Exercise, Walking, Type 2 diabetes, Therapy

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on October 16, 2014