Italian Diabetes and Exercise Study 2

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Italian Diabetes and Exercise Study 2 - A Long-term Behavioural Intervention for Adoption and Maintenance of a Physically Active Lifestyle

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Behavioral: Theoretical & practical exercise counseling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Standard care including physician recommendations for daily PA | |
| Experimental: Exercise<br>Theoretical & practical exercise counseling including 2 sessions/ per wk for 1 month of supervised exercise training | Behavioral: Theoretical & practical exercise counseling<br>* 2 sessions/ per wk for 1 month<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical Activity Behavior | Volume of physical activity in METs-hr/wk; sedentary time; time spent in moderate-to-vigorous physical activity | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical fitness | Physical fitness (Cardiorespiratory, fitness, muscle strength, hip and trunk flexibility) | 3 years | 
| Modifiable cardiovascular risk factors | Modifiable cardiovascular risk factors (HbA1c, lipids, blood pressure, C-reactive protein, CHD 10-year risk scores) | 3 years | 
| Health related quality of life | Quality of life (Physical and mental SF-36 scores) | 3 years | 
| Musculo-skeletal disturbances | Musculo-skeletal symproms and scores | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes mellitus, diabetes education, behavioral therapy, behavior modification, physical activity, supervised exercise, physical fitness, HbA1c, modifiable cardiovascular risk factors, quality of life