Yoga and Aerobic Exercise in Psychosis (YEP)
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.
|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|
- 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).
- 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.
|Study Start Date:||November 2010|
|Study Completion Date:||October 2014|
|Primary Completion Date:||April 2013 (Final data collection date for primary outcome measure)|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01207219
|Department of Psychiatry, LKS Faculty of Medicine, the University of Hong Kong|
|Hong Kong, Hong Kong, 852|
|Study Chair:||Jessie, JX Lin, PhD||Department of Psychiatry, the University of Hong Kong|