Italian Diabetes and Exercise Study 2 (IDES-2)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Type 2 Diabetes |
Behavioral: Theoretical & practical exercise counseling |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Italian Diabetes and Exercise Study 2 - To Integrate & Incorporate Leisure Time Physical Activity (LTPA) for Adoption and Maintenance of PA as a Long-term Behavioral Intervention |
- Physical Activity Behavior [ Time Frame: 3 years ] [ Designated as safety issue: No ]Volume of physical activity in METs-hr/wk
- Physical fitness [ Time Frame: 3 years ] [ Designated as safety issue: No ]Physical fitness (Cardiorespiratory, fitness, muscle strength, hip and trunk flexibility)
- Modifiable cardiovascular risk factors [ Time Frame: 3 years ] [ Designated as safety issue: No ]Modifiable cardiovascular risk factors (HbA1c, lipids, blood pressure, C-reactive protein, CHD 10-year risk scores)
- Health related quality of life [ Time Frame: 3 years ] [ Designated as safety issue: No ]Quality of life (Physical and mental SF-36 scores)
| Estimated Enrollment: | 300 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | November 2017 |
| Estimated Primary Completion Date: | October 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: Control
Standard care including physician recommendations for daily PA
|
|
|
Experimental: Exercise
Theoretical & practical exercise counseling including 2 sessions/ per wk for 1 month of supervised exercise training
|
Behavioral: Theoretical & practical exercise counseling
2 sessions/ per wk for 1 month
Other Name: Theoretical & practical exercise counseling
|
Detailed 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.
Eligibility| Ages Eligible for Study: | 40 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Giuseppe Pugliese, MD, PhD | +39 06 33775440 | giuseppe.pugliese@uniroma1.it |
| Italy | |
| University of Rome La Sapienza, Department of Clinical and Molecular Medicine, Sant'Andrea Hospital, Diabetes Unit | Recruiting |
| Rome, RM, Italy, 00189 | |
| Contact: Laura Salvi, MD +39 0633775249 adamas83@hotmail.it | |
| Sub-Investigator: Laura Salvi, MD | |
| Study Director: | Stefano Balducci, MD | Sant'Andrea Hospital, Diabetes Unit |
More Information
Additional Information:
Publications:
| Responsible Party: | Giuseppe Pugliese, MD, PhD, Metabolic Fitness Association, Italy |
| ClinicalTrials.gov Identifier: | NCT01600937 History of Changes |
| Other Study ID Numbers: | MFA-12-01 |
| Study First Received: | May 16, 2012 |
| Last Updated: | October 10, 2012 |
| Health Authority: | Italy: Ethics Committee |
Keywords provided by Metabolic Fitness Association, Italy:
|
diabetes mellitus diabetes education behavioral therapy behavior modification physical activity |
supervised exercise physical fitness HbA1c modifiable cardiovascular risk factors quality of life |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 21, 2013