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Yoga and Exercise in Psychosis (YEP)

This study is currently recruiting participants.
Verified August 2011 by The University of Hong Kong
Sponsor:
Information provided by:
The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01207219
First received: September 16, 2010
Last updated: August 10, 2011
Last verified: August 2011
History of Changes
  Purpose

The current study aims to evaluate the impacts of Yoga and Physical Exercise on the structural change to the hippocampus, functional change in Default Mode Network (DMN), neure-cognitive function, and clinical symptoms in psychosis. A total of 120 female subjects who aging from 18-55 years old, and diagnosed with psychosis within the past 5 years, will be randomized into 3 groups: 1) Yoga therapy, 2) Physical exercise, and 3) a control group, made up of individuals in the yoga or exercise waitlist. All groups will try to be kept consistent with their medication with no more than 25% change in their entry level dosage for at least six weeks. This study will assess the physical fitness, body-perception, drug adherence, and medication side effects in addition to the outcome domains of structural and functional Magnetic Resonance Imaging (MRI), neure-cognitive function, clinical symptoms and quality of life.


Condition Intervention
Psychotic Disorder
 Behavioral: Yoga therapy
Behavioral: Physical exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Impacts of Yoga and Exercise on Neure-cognitive Function and Symptoms in Early Psychosis - A Single Blind Randomized Controlled Clinical Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The University of Hong Kong:

Primary Outcome Measures:
  • Structural and Functional Magnetic Resonance Imaging [ Time Frame: at 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cognitive function [ Time Frame: at 12 weeks ] [ Designated as safety issue: No ]
  • Clinical symptoms [ Time Frame: at 12 weeks ] [ Designated as safety issue: No ]
  • Side effect of psychotropic medications with the Udvalg for Kliniske Undersøgelser (UKU) [ Time Frame: at 12 weeks ] [ Designated as safety issue: Yes ]
  • Fitness measure [ Time Frame: at 12 weeks ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: at 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: September 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Yoga therapy
Yoga therapy includes breathing control (5-10minutes), Posture(40-45minutes), and relaxation (5-10minutes).
 Behavioral: Yoga therapy
Yoga therapy, including breathing control, postures, and relaxation. 60 minutes for each session, 3 sessions weekly for 12 weeks.
Experimental: Physical Exercise
Physical exercise includes cycling, walking, and/or resistance training
 Behavioral: Physical exercise
cycling, walking, and/or resistance training, 45-55 minutes for each session, 3 sessions weekly for 12 weeks.
No Intervention: Waiting list
Patients in waiting list will be acted as control group.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Females aged from 18 to 55 years old
  • Based on the SCID diagnosed to have schizophrenia, schizoaffective disorder, schizophreniform psychosis, brief psychosis nos, or delusional disorder. Duration of illness is less than 5 years.
  • Cantonese-speaking chinese
  • Ability to understand the nature of the study and to give an informed consent
  • Fewer than 10 hours of yoga or aerobic exercise in the previous 3 months

Exclusion Criteria:

  • Severe physical illness (myocardial infarction, hypertension, fracture, spinal problem), seizure disorders, mental retardation or comorbid substance dependence, and unstable psychotic symptoms
  • Known pregnancy, or other contraindication to Magnetic Resonance Imaging (MRI)
  • A history of brain trauma or organic brain disease
  • Known history of intellectual disability or special school attendance
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01207219

Contacts
Contact: Jessie, JX Lin, Master +852-22553064 jingxia.lin@gmail.com

Locations
Hong Kong
Department of Psychiatry, LKS Faculty of Medicine, the University of Hong Kong Recruiting
Hong Kong, Hong Kong, 852
Contact: Jessie, JX Lin, Master     +85222553064     jingxia.lin@gmail.com    
Sub-Investigator: Eric Chen, Prof.            
Sponsors and Collaborators
The University of Hong Kong
Investigators
Principal Investigator: Jessie, JX Lin, Master Department of Psychiatry, the University of Hong Kong
  More Information

No publications provided

Responsible Party: Ms. Jingxia Lin, Department of Psychiatry, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT01207219     History of Changes
Other Study ID Numbers: YEP_2010
Study First Received: September 16, 2010
Last Updated: August 10, 2011
Health Authority: Hong Kong: Ethics Committee

Keywords provided by The University of Hong Kong:
psychosis
yoga
exercise
neure-cognition

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on June 18, 2013