N/A
N=124
Yoga and Aerobic Exercise in Psychosis
Psychotic Disorder
Bottom Line
View on ClinicalTrials.gov: NCT01207219 ↗Enrolled (actual)
124
Serious AEs
0.0%
Results posted
Dec 2014
Primary outcome: Primary: Verbal Acquisition — 22.8; 22.0; 22.7; 29.5 correctly encoded words — p=<0.01
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Yoga therapy (Behavioral); Aerobic exercise (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- The University of Hong Kong
- Primary completion
- Apr 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Verbal Acquisition |
22.8; 22.0; 22.7; 29.5; 28.8; 24.8 | <0.01 sig |
| PRIMARY Verbal Retention |
14.9; 15.1; 14.5; 19.4; 21.0; 16.6 | — |
| PRIMARY Working Memory |
6.8; 6.8; 7.1; 8.5; 9.4; 7.7 | — |
| PRIMARY Attention and Concentration |
0.76; 0.71; 0.74; 0.84; 0.77; 0.73 | — |
| SECONDARY Severity of Symptoms |
46.9; 46.8; 45.4; 37.4; 39.5; 49.0 | — |
Summary
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01207219). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.