Clinical trial NCT01115205: 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
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Exercise, Walking, Type 2 diabetes, Therapy
Lead sponsor: Universita di Verona
Sponsor class: OTHER
First posted: 2010-05-04
Enrollment: 59
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in haemoglobin A1c (HbA1c) levels
timeFrame: 4 months
Secondary outcomes:
measure: Change in Body weight
timeFrame: 4 months
measure: Change in Fasting plasma glucose levels
timeFrame: 4 months
measure: Change in Total Cholesterol levels
timeFrame: 4 months
measure: Change in HDL Cholesterol levels
timeFrame: 4 months
measure: Change in LDL Cholesterol levels
timeFrame: 4 months
measure: Change in Triglycerides levels
timeFrame: 4 months
measure: Change in Blood Pressure
timeFrame: 4 months
measure: Change in 6 minutes walk distance
timeFrame: 4 months
measure: Change in C-reactive protein levels
timeFrame: 4 months
measure: Change in Energy expenditure through voluntary physical activity
timeFrame: 4 months
measure: Change in Antidiabetic medications
timeFrame: 4 months
measure: Compliance with walking sessions
timeFrame: 4 months
Other outcomes:
Locations:
Study officials:
affiliation: Universita di Verona
name: Paolo Moghetti, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.