Back to resultsExercise and Diet Program for Schizophrenia Patients Who Are Taking Atypical Antipsychotic Medications
Primary Purpose
Schizophrenia
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Exercise program
Diet
Sponsored by
About this trial
This is an interventional supportive care trial for Schizophrenia focused on measuring Schizophrenia, weight gain, atypical neuroleptics
Eligibility Criteria
Inclusion Criteria:
- Schizophrenia
- Atypical neuroleptics
Exclusion Criteria:
- Medical illness preventing exercise
Sites / Locations
- Sheba Medical Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Exercise and Diet program
Arm Description
All patients recruited in the study, participated in an homogeneous exercise program and diet.
Outcomes
Primary Outcome Measures
Weight loss
The weight of the participants of the trial was monitored during the trial, while they were following the exercise program and the diet, starting from the baseline until end of study/early withdrawal.
Secondary Outcome Measures
Abdomen circumference
The circumference of the abdomen of the participants of the trial was monitored during the trial, while they were following the exercise program and the diet, starting from the baseline until end of study/early withdrawal.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01409590
Brief Title
Exercise and Diet Program for Schizophrenia Patients Who Are Taking Atypical Antipsychotic Medications
Official Title
Exercise and Diet Program for Schizophrenia Patients Who Are Taking Atypical Antipsychotic Medications
Study Type
Interventional
2. Study Status
Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
September 2006 (Actual)
Study Completion Date
August 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sheba Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
In this study the investigators will recruit patients with the diagnosis of schizophrenia that are taking atypical neuroleptics and that are willing to participate in an exercise and diet program. The investigators will measure weight and abdomen circumference.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, weight gain, atypical neuroleptics
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise and Diet program
Arm Type
Other
Arm Description
All patients recruited in the study, participated in an homogeneous exercise program and diet.
Intervention Type
Behavioral
Intervention Name(s)
Exercise program
Intervention Description
Homogenous exercise program in local fitness centers
Intervention Type
Behavioral
Intervention Name(s)
Diet
Intervention Description
Weigh loss diet program prescribed by a professional nutritionist
Primary Outcome Measure Information:
Title
Weight loss
Description
The weight of the participants of the trial was monitored during the trial, while they were following the exercise program and the diet, starting from the baseline until end of study/early withdrawal.
Time Frame
One year
Secondary Outcome Measure Information:
Title
Abdomen circumference
Description
The circumference of the abdomen of the participants of the trial was monitored during the trial, while they were following the exercise program and the diet, starting from the baseline until end of study/early withdrawal.
Time Frame
One year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Schizophrenia
Atypical neuroleptics
Exclusion Criteria:
Medical illness preventing exercise
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Revital Amiaz, MD
Organizational Affiliation
Sackler School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sheba Medical Center
City
Tel Hashomer
State/Province
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Exercise and Diet Program for Schizophrenia Patients Who Are Taking Atypical Antipsychotic Medications
We'll reach out to this number within 24 hrs