Yoga and Aerobic Exercise in Psychosis

NCT01207219 | Completed Results DMC

• 1 other identifier: YEP_2010
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Psychotic Disorder

Keywords

psychosis; yoga; aerobic exercise; memory; attention; neuro cognition

Outcome Measures

Primary Outcomes (4)

• Verbal Acquisition

  Total number of corrected encoded words in the first three trials in the random condition of Hong Kong List Learning test.

  baseline and 12 weeks

• Verbal Retention

  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.

  baseline and 12 weeks

• Working Memory

  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.

  baseline and 12 weeks

• Attention and Concentration

  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).

  baseline and 12 weeks

Secondary Outcomes (1)

• Severity of Symptoms

  Baseline and 12 weeks

Study Arms (3)

Yoga therapy

EXPERIMENTAL

Hatha yoga including breathing control (10 minutes), body posture(40-45minutes), and relaxation (5 minutes).

Behavioral: Yoga therapy

Aerobic exercise

EXPERIMENTAL

Aerobic exercise includes walking on the treadmill for 15-20 minutes and stationary cycling for 25-30 minutes.

Behavioral: Aerobic exercise

Waitlist group

NO INTERVENTION

Patients in waiting list will be treated as usual and acted as control group.

Interventions

Yoga therapy BEHAVIORAL

3 sessions per week for 12 weeks, total 36 sessions. Each session lasts around one hour.

Yoga therapy

Aerobic exercise BEHAVIORAL

3 session per week for 12 weeks, total 36 sessions. Each session lasts around one hour.

Aerobic exercise

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Department of Psychiatry, LKS Faculty of Medicine, the University of Hong Kong

Hong Kong, 852, Hong Kong

Location

Related Publications (11)

• Addington J, Addington D, Gasbarre L. Distractibility and symptoms in schizophrenia. J Psychiatry Neurosci. 1997 May;22(3):180-4.

  PMID: 9183116 BACKGROUND

• Duraiswamy G, Thirthalli J, Nagendra HR, Gangadhar BN. Yoga therapy as an add-on treatment in the management of patients with schizophrenia--a randomized controlled trial. Acta Psychiatr Scand. 2007 Sep;116(3):226-32. doi: 10.1111/j.1600-0447.2007.01032.x.

  PMID: 17655565 BACKGROUND

• Heyn P, Abreu BC, Ottenbacher KJ. The effects of exercise training on elderly persons with cognitive impairment and dementia: a meta-analysis. Arch Phys Med Rehabil. 2004 Oct;85(10):1694-704. doi: 10.1016/j.apmr.2004.03.019.

  PMID: 15468033 BACKGROUND

• Kelley WM, Macrae CN, Wyland CL, Caglar S, Inati S, Heatherton TF. Finding the self? An event-related fMRI study. J Cogn Neurosci. 2002 Jul 1;14(5):785-94. doi: 10.1162/08989290260138672.

  PMID: 12167262 BACKGROUND

• Kubesch S, Bretschneider V, Freudenmann R, Weidenhammer N, Lehmann M, Spitzer M, Gron G. Aerobic endurance exercise improves executive functions in depressed patients. J Clin Psychiatry. 2003 Sep;64(9):1005-12. doi: 10.4088/jcp.v64n0905.

  PMID: 14628975 BACKGROUND

• Lam LC, Tam CW, Lui VW, Chan WC, Chan SS, Chiu HF, Wong A, Tham MK, Ho KS, Chan WM. Modality of physical exercise and cognitive function in Hong Kong older Chinese community. Int J Geriatr Psychiatry. 2009 Jan;24(1):48-53. doi: 10.1002/gps.2072.

  PMID: 18615844 BACKGROUND

• Lautenschlager NT, Cox KL, Flicker L, Foster JK, van Bockxmeer FM, Xiao J, Greenop KR, Almeida OP. Effect of physical activity on cognitive function in older adults at risk for Alzheimer disease: a randomized trial. JAMA. 2008 Sep 3;300(9):1027-37. doi: 10.1001/jama.300.9.1027.

  PMID: 18768414 BACKGROUND

• Pajonk FG, Wobrock T, Gruber O, Scherk H, Berner D, Kaizl I, Kierer A, Muller S, Oest M, Meyer T, Backens M, Schneider-Axmann T, Thornton AE, Honer WG, Falkai P. Hippocampal plasticity in response to exercise in schizophrenia. Arch Gen Psychiatry. 2010 Feb;67(2):133-43. doi: 10.1001/archgenpsychiatry.2009.193.

  PMID: 20124113 BACKGROUND

• Sharma VK, Das S, Mondal S, Goswami U, Gandhi A. Effect of Sahaj Yoga on neuro-cognitive functions in patients suffering from major depression. Indian J Physiol Pharmacol. 2006 Oct-Dec;50(4):375-83.

  PMID: 17402267 BACKGROUND

• Whitfield-Gabrieli S, Thermenos HW, Milanovic S, Tsuang MT, Faraone SV, McCarley RW, Shenton ME, Green AI, Nieto-Castanon A, LaViolette P, Wojcik J, Gabrieli JD, Seidman LJ. Hyperactivity and hyperconnectivity of the default network in schizophrenia and in first-degree relatives of persons with schizophrenia. Proc Natl Acad Sci U S A. 2009 Jan 27;106(4):1279-84. doi: 10.1073/pnas.0809141106. Epub 2009 Jan 21.

  PMID: 19164577 BACKGROUND

• Woodward ML, Lin J, Gicas KM, Su W, Hui CLM, Honer WG, Chen EYH, Lang DJ. Medial temporal lobe cortical changes in response to exercise interventions in people with early psychosis: A randomized controlled trial. Schizophr Res. 2020 Sep;223:87-95. doi: 10.1016/j.schres.2020.05.043. Epub 2020 May 30.

  PMID: 32487465 DERIVED

MeSH Terms

Conditions

Psychotic Disorders

Interventions

Yoga; Exercise

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Limitations and Caveats

Lack of a healthy control group; a measurement bias may exist in the HKLLT because the same word list was used for baseline and 12 weeks.

Results Point of Contact

• Title: Dr.Lin Jingxia
• Organization: The Department of Psychiatry,HKU

jingxia.lin@gmail.com

+85222553064

Study Officials

• Jessie, JX Lin, PhD

  Department of Psychiatry, the University of Hong Kong

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Head

Study Record Dates

• First Submitted: September 16, 2010
• First Posted: September 22, 2010
• Study Start: November 1, 2010
• Primary Completion: April 1, 2013
• Study Completion: October 1, 2014
• Last Updated: December 9, 2014
• Results First Posted: December 9, 2014

Record last verified: 2014-12

Locations

HK (1)