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

University of Verona

Status: Completed

Conditions: Type 2 Diabetes

Treatments: Behavioral: Standard counselling procedure; Behavioral: Supervised walking

Study type: Interventional

Funder types: Other

Identifiers

NCT01115205

CE 1264

Details and patient eligibility

About

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.

Full 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.

Enrollment: 59 patients

Sex: All

Ages: 50 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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59 participants in 2 patient groups

Supervised walking groups

Experimental group

Description:

Patients included in walking groups, under the supervision of a qualified personal trainer.

Treatment:

Behavioral: Supervised walking

Controls

Active Comparator group

Description:

Patients receiving the standard counselling procedures of the Verona Diabetic Clinic.

Treatment:

Behavioral: Standard counselling procedure