Italian Diabetes and Exercise Study 2

Not Applicable

Completed

• Conditions: Type 2 Diabetes
• Interventions: Behavioral: Theoretical & practical exercise counseling

• Registration Number: NCT01600937
• Lead Sponsor: Metabolic Fitness Association, Italy

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2012-05-16
• Study First Submitted QC: 2012-05-16
• Study First Posted: 2012-05-17
• Study Start: 2012-10
• Primary Completion: 2017-02-28
• Study Completion: 2017-02-28
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-22
• Last Update Posted: 2017-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise	Theoretical & practical exercise counseling	Theoretical \& practical exercise counseling including 2 sessions/ per wk for 1 month of supervised exercise training

Primary Outcome Measures

Name	Time	Method
Physical Activity Behavior	3 years	Volume of physical activity in METs-hr/wk; sedentary time; time spent in moderate-to-vigorous physical activity

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Rome La Sapienza, Department of Clinical and Molecular Medicine, Sant'Andrea Hospital, Diabetes Unit; 🇮🇹 Rome, RM, Italy