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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01409590
• Other study ID #: SHEBA-05-3627-RA-CTIL
• Status: Completed
• Phase: N/A
• First received: August 3, 2011
• Last updated: August 3, 2011
• Start date: May 2005
• Est. completion date: August 2009

Study information

• Verified date: August 2011
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 2009
• Est. primary completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• Schizophrenia

• Atypical neuroleptics

Exclusion Criteria:

• Medical illness preventing exercise

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Behavioral:
• Exercise program
Homogenous exercise program in local fitness centers
• Diet
Weigh loss diet program prescribed by a professional nutritionist

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Tel Hashomer	Ramat Gan

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	One year	No
Secondary	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.	One year	No