We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Exercise and Diet Program for Schizophrenia Patients Who Are Taking Atypical Antipsychotic Medications

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01409590
First Posted: August 4, 2011
Last Update Posted: August 4, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sheba Medical Center
  Purpose
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.

Condition Intervention
Schizophrenia Behavioral: Exercise program Behavioral: Diet

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Exercise and Diet Program for Schizophrenia Patients Who Are Taking Atypical Antipsychotic Medications

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • Weight loss [ Time Frame: One year ]
    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 [ Time Frame: One year ]
    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.


Enrollment: 100
Study Start Date: May 2005
Study Completion Date: August 2009
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Exercise and Diet program
All patients recruited in the study, participated in an homogeneous exercise program and diet.
Behavioral: Exercise program
Homogenous exercise program in local fitness centers
Behavioral: Diet
Weigh loss diet program prescribed by a professional nutritionist

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Schizophrenia
  • Atypical neuroleptics

Exclusion Criteria:

  • Medical illness preventing exercise
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01409590


Locations
Israel
Sheba Medical Center
Tel Hashomer, Ramat Gan, Israel, 52621
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Revital Amiaz, MD Sackler School of Medicine
  More Information

Responsible Party: Revital Amiaz, MD, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01409590     History of Changes
Other Study ID Numbers: SHEBA-05-3627-RA-CTIL
First Submitted: August 3, 2011
First Posted: August 4, 2011
Last Update Posted: August 4, 2011
Last Verified: August 2011

Keywords provided by Sheba Medical Center:
Schizophrenia
weight gain
atypical neuroleptics

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs