Trial record 7 of 9 for:    Open Studies | adoption

Italian Diabetes and Exercise Study 2 (IDES-2)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Metabolic Fitness Association, Italy
Sponsor:
Collaborator:
University of Roma La Sapienza
Information provided by (Responsible Party):
Giuseppe Pugliese, Metabolic Fitness Association, Italy
ClinicalTrials.gov Identifier:
NCT01600937
First received: May 16, 2012
Last updated: October 10, 2012
Last verified: October 2012
  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

Resource links provided by NLM:


Further study details as provided by Metabolic Fitness Association, Italy:

Primary Outcome Measures:
  • Physical Activity Behavior [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Volume of physical activity in METs-hr/wk


Secondary Outcome Measures:
  • 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
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01600937

Contacts
Contact: Giuseppe Pugliese, MD, PhD +39 06 33775440 giuseppe.pugliese@uniroma1.it

Locations
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         
Sponsors and Collaborators
Metabolic Fitness Association, Italy
University of Roma La Sapienza
Investigators
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 July 22, 2014