Yoga and Aerobic Exercise in Psychosis (YEP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eric Y H Chen, The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01207219
First received: September 16, 2010
Last updated: December 8, 2014
Last verified: December 2014
  Purpose

The current study aims to evaluate the impacts of yoga and aerobic exercise on neuro-cognitive function, symptoms and brain changes in early psychosis. A total of 120 female subjects who aging from 18-55 years old, and diagnosed with psychotic disorders within the past 5 years, will be randomized into 3 groups: 1) yoga therapy, 2) aerobic exercise, and 3) waitlist group as the control. 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. The primary outcomes of the present study will be neuro-cognitive changes; the secondary outcomes will be changes of brain structure and function.


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

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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Verbal Acquisition [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: No ]
    Total number of corrected encoded words in the first three trials in the random condition of Hong Kong List Learning test.

  • Verbal Retention [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: No ]
    The total number of correctly recalled words after short-term (10 minutes) and long-term (30 minutes) delay in the random condition of Hong Kong List Learning test.

  • Working Memory [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: No ]
    measured by Digit Span backwards test. In this test, the subject was asked to recall a series of numbers in reverse order. The correctly recalled series were scored as 1, and the test contains 14 sequences of numbers. The range of working memory score is from 0 to 14, with higher values representing better outcome.

  • Attention and Concentration [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: No ]
    measured by Letter Cancellation test Q score. The basic version of the task consists of six 52-character rows in which the target character is randomly interspersed approximately 18 times in each row. Subjects were asked to cancel the letter "C" and "E" as quickly as possible. The time to completion, number of error and omission items were recorded. A "quality of search" index (Q), developed by Geldmacher et al., was applied for the analysis. Q is the ratio of correct number to total number of targets multiplied by the ratio of correct number per second. Higher Q scores represent more efficient performance and better attention and concentration. Q scores could range from 0 (worst possible outcome) to 1 (best possible outcome).


Secondary Outcome Measures:
  • Severity of Symptoms [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    PANSS total score is computed by summing the scores of positive, negative and general symptom subscores. The range of PANSS total score is from 30 to 210, range of PANSS positive and negative subscores is from 7 to 49, range of PANSS general symptoms subscore is from 16 to 112, with higher values representing worse outcome. CDS total score is computed by summing the scores of nine items of the scale. The range of CDS total score is from 0 to 27, with higher values representing worse outcome.


Enrollment: 140
Study Start Date: November 2010
Study Completion Date: October 2014
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Yoga therapy
Hatha yoga including breathing control (10 minutes), body posture(40-45minutes), and relaxation (5 minutes).
Behavioral: Yoga therapy
3 sessions per week for 12 weeks, total 36 sessions. Each session lasts around one hour.
Experimental: Aerobic exercise
Aerobic exercise includes walking on the treadmill for 15-20 minutes and stationary cycling for 25-30 minutes.
Behavioral: Aerobic exercise
3 session per week for 12 weeks, total 36 sessions. Each session lasts around one hour.
No Intervention: Waitlist group
Patients in waiting list will be treated as usual and acted as control group.

  Show Detailed Description

  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.
  • Based on the Diagnostic and Statistical Manual (DSM-IV) diagnosed to have schizophrenia, schizoaffective disorder, schizophreniform Psychosis, brief psychotic disorders, psychosis not otherwise specified and delusional disorder. Duration of illness is less than 5 years (including 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 and vigorous aerobic exercise (equivalent to jogging at 10 km/hr) in the previous 3 months.

Exclusion criteria

  • Severe physical illness (myocardial infarction, hypertension, fracture, spinal problem), seizure disorders, mental retardation or comorbid substance dependence. Heart rate and blood pressure will be measured at the baseline to exclude the patients with abnormal cardiovascular activities.
  • Unstable psychotic symptoms.
  • Known pregnancy, or other contraindication to MRI.
  • A history of brain trauma or organic brain disease.
  • Known history of intellectual disability or special school attendance.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01207219

Locations
Hong Kong
Department of Psychiatry, LKS Faculty of Medicine, the University of Hong Kong
Hong Kong, Hong Kong, 852
Sponsors and Collaborators
The University of Hong Kong
Investigators
Study Chair: Jessie, JX Lin, PhD Department of Psychiatry, the University of Hong Kong
  More Information

Publications:

Responsible Party: Eric Y H Chen, Professor, Head, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT01207219     History of Changes
Other Study ID Numbers: YEP_2010
Study First Received: September 16, 2010
Results First Received: June 17, 2014
Last Updated: December 8, 2014
Health Authority: Hong Kong: Ethics Committee

Keywords provided by The University of Hong Kong:
psychosis
yoga
aerobic exercise
memory
attention
neuro cognition

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

ClinicalTrials.gov processed this record on August 27, 2015