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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Behavioral: Supervised walking; Behavioral: Standard counselling procedure

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.

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in haemoglobin A1c (HbA1c) levels	The measurement of HbA1c is carried out with a DCCT-aligned method.	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Body weight		4 months
Change in Fasting plasma glucose levels		4 months
Change in Total Cholesterol levels		4 months
Change in HDL Cholesterol levels		4 months
Change in LDL Cholesterol levels		4 months
Change in Triglycerides levels		4 months
Change in Blood Pressure		4 months
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.	4 months
Change in C-reactive protein levels		4 months
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.	4 months
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.	4 months
Compliance with walking sessions	Attendance at the scheduled walking sessions is recorded for each patient.	4 months

Collaborators and Investigators

• Sponsor: Universita di Verona
• Investigators: Principal Investigator: Paolo Moghetti, M.D., Ph.D., Universita di Verona

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2006
• Primary Completion (Actual): January 1, 2008
• Study Completion (Actual): January 1, 2009

Study Registration Dates

• First Submitted: April 26, 2010
• First Submitted That Met QC Criteria: April 29, 2010
• First Posted (Estimate): May 4, 2010

Study Record Updates

• Last Update Posted (Estimate): May 5, 2010
• Last Update Submitted That Met QC Criteria: May 3, 2010
• Last Verified: May 1, 2010

More Information

Terms related to this study

• Keywords: Exercise, Walking, Type 2 diabetes, Therapy
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: CE 1264