This trial is active, not recruiting.

Condition type 2 diabetes
Treatment theoretical & practical exercise counseling
Phase phase 3
Sponsor Metabolic Fitness Association, Italy
Collaborator University of Roma La Sapienza
Start date October 2012
End date October 2016
Trial size 300 participants
Trial identifier NCT01600937, MFA-12-01


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
(No Intervention)
Standard care including physician recommendations for daily PA
Theoretical & practical exercise counseling including 2 sessions/ per wk for 1 month of supervised exercise training
theoretical & practical exercise counseling Theoretical & practical exercise counseling
2 sessions/ per wk for 1 month

Primary Outcomes

Physical Activity Behavior
time frame: 3 years

Secondary Outcomes

Physical fitness
time frame: 3 years
Modifiable cardiovascular risk factors
time frame: 3 years
Health related quality of life
time frame: 3 years
Musculo-skeletal disturbances
time frame: 3 years

Eligibility Criteria

Male or female participants from 40 years up to 80 years old.

Inclusion Criteria: 1. Type 2 diabetes 2. Age 40 to 80 years at screening 3. BMI >27<40 kg/m2 4. Sedentary for at least 6 months 5. Treated with prescribed diet and/or OHA and insulin 6. Able to walk for 1.6 Km unaided. 7. Eligible after positive outcome of cardiac evaluation Exclusion Criteria: 1. 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 2. A history of clinical evidence of severe cardiovascular disease which may limit or be a contraindication for exercise 3. Clinical evidence of vestibular dysfunction 4. Angina and related symptoms 5. Postural hypotension defined as a fall in arterial blood pressure when changing position of >20 mmHg (systole) or >10 mmHg (diastole 6. History of plantar sores

Additional Information

Official title Italian Diabetes and Exercise Study 2 - A Long-term Behavioural Intervention for Adoption and Maintenance of a Physically Active Lifestyle
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Metabolic Fitness Association, Italy.