Italian Diabetes and Exercise Study 2 (IDES-2)

Metabolic Fitness Association, Italy

Status

Completed

Conditions

Type 2 Diabetes

Treatments

Behavioral: Theoretical & practical exercise counseling

Study type

Interventional

Funder types

Other

Identifiers

NCT01600937

MFA-12-01

Details and patient eligibility

About

Current guidelines recommend supervised mixed (aerobic+resistance) physical activity to ensure optimal benefits to control blood glucose, lipids, blood pressure, and other cardiovascular risk and to minimize injuries. However, these guidelines are difficult to put into action for a number of barriers and poor long-term patient compliance. This project will assess the effect of a behavioral intervention strategy on the promotion and maintenance of physical activity in type 2 diabetes.

Full description

An increasing prevalence of type 2 diabetes is associated with an aging population, a significant rise in the prevalence of obesity, and a sedentary lifestyle. In Italy, prevalence of diabetes is approximately 6%, with 90-95% of diabetic subjects having type 2. Strong evidence supports the importance of physical activity in the management of type 2 diabetes. However, current guidelines are difficult to put into action in this target population because of barriers and poor patient long-term compliance so it is difficult even identify the best strategies for physical activity behavior change. Existing studies employ small groups and clinically-based approaches with limited theoretical grounding for recommended health behavior change. Most fail to offer practical, sustainable, economically viable solutions, with documented long-term intervention efficacy. This study proposes to monitor any objective measurable changes in LTPA over a 3-year period after behavioral interventions (Physician recommendations for daily PA with and without supervised exercise training including individual theoretic & practical counseling). Hopefully, such behavioral intervention would offer a feasible procedure for long-term maintenance of physical activity and thus meet the call for a change of paradigm to move beyond the limited clinical focus by including theoretically population-based and "real-life" approaches for the management Type 2 Diabetes.

After the selection for eligibility and a run-in period, patients will be randomized in two groups: 1) exercise (EXE) group receiving theoretical & practical exercise counseling including 2 sessions/ per wk for 1 month of supervised exercise training; and 2) control (CON) group receiving standard care including general physician recommendations for daily PA. Changes in physical activity behavior will be quantified using an accelerometer, in addition to a daily diary.

Enrollment

300 patients

Sex

All

Ages

40 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Type 2 diabetes
Age 40 to 80 years at screening
BMI >27<40 kg/m2
Sedentary for at least 6 months
Treated with prescribed diet and/or OHA and insulin
Able to walk for 1.6 Km unaided.
Eligible after positive outcome of cardiac evaluation

Exclusion criteria

All patients with a history of central nervous dysfunction such as hemiparesis, myelopathies, cerebral ataxia, significant musculoskeletal deformities such as an amputation, dysmetria or scoliosis, patients with movement abnormalities or arthritis limited by pain when exercising
A history of clinical evidence of severe cardiovascular disease which may limit or be a contraindication for exercise
Clinical evidence of vestibular dysfunction
Angina and related symptoms
Postural hypotension defined as a fall in arterial blood pressure when changing position of >20 mmHg (systole) or >10 mmHg (diastole
History of plantar sores