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

Not Applicable

Completed

• Conditions: Type 2 Diabetes
• Interventions: Behavioral: Supervised walking; Behavioral: Standard counselling procedure

• Registration Number: NCT01115205
• Lead Sponsor: Universita di Verona

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.

Study Timeline

• Study Start: 2006-03
• Primary Completion: 2008-01
• Study Completion: 2009-01
• Study First Submitted: 2010-04-26
• Study First Submitted QC: 2010-04-29
• Status Verified: 2010-05
• Last Update Submitted: 2010-05-03
• Study First Posted: 2010-05-04
• Last Update Posted: 2010-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Supervised walking groups	Supervised walking	Patients included in walking groups, under the supervision of a qualified personal trainer.
Controls	Standard counselling procedure	Patients receiving the standard counselling procedures of the Verona Diabetic Clinic.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in Body weight	4 months
Change in C-reactive protein levels	4 months
Change in Blood Pressure	4 months
Change in HDL Cholesterol levels	4 months
Change in Total Cholesterol levels	4 months
Change in Antidiabetic medications	4 months	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.
Change in Fasting plasma glucose levels	4 months
Change in Energy expenditure through voluntary physical activity	4 months	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 Triglycerides levels	4 months
Change in LDL Cholesterol levels	4 months
Change in 6 minutes walk distance	4 months	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.
Compliance with walking sessions	4 months	Attendance at the scheduled walking sessions is recorded for each patient.