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

NCT ID: NCT01115205

Last Updated: 2010-05-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2009-01-31

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.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Supervised walking groups

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

Group Type: EXPERIMENTAL

Supervised walking

Intervention Type: BEHAVIORAL

Walk training, 3 sessions per week for 4 months, under the supervision of a qualified personal trainer.

Controls

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

Group Type: ACTIVE_COMPARATOR

Standard counselling procedure

Intervention Type: BEHAVIORAL

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.

Interventions

Supervised walking

Walk training, 3 sessions per week for 4 months, under the supervision of a qualified personal trainer.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universita di Verona

OTHER

Sponsor Role: lead

Responsible Party

Department of Medicine, Universita di Verona

Principal Investigators

Paolo Moghetti, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Universita di Verona

References

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.

Reference Type: DERIVED

PMID: 20980426 (View on PubMed)

Other Identifiers

CE 1264

Identifier Type: -

Identifier Source: org_study_id