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

This study has been completed.
Sponsor:
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01409590
First received: August 3, 2011
Last updated: NA
Last verified: August 2011
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • Weight loss [ Time Frame: One year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Schizophrenia
  • Atypical neuroleptics

Exclusion Criteria:

  • Medical illness preventing exercise
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Revital Amiaz, MD, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01409590     History of Changes
Other Study ID Numbers: SHEBA-05-3627-RA-CTIL
Study First Received: August 3, 2011
Last Updated: August 3, 2011
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

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

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
 Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on May 19, 2013