Exercise and Overnight Motor Sequence Task (EOMST)

12-week Aerobic-Anaerobic Transition Exercise Intervention and Overnight Sleep-dependent Procedural Memory Consolidation in Patients With Schizophrenia

The objective of this randomized controlled trial (RCT) is to compare the changes of the sleep-related memory functions in patients with psychosis after they have completed the 12-week high-intensity exercise intervention, the 12-week low-intensity exercise intervention, or the 12-week controlled non-exercise intervention respectively. Fifty-one patients with psychosis, patients who received either the high-intensity exercise or low-intensity exercise as intervention shown a significant improvement to their impaired sleep-related memory function, while those who received non-exercise intervention has no such improvement. Moreover, high-intensity exercise may have a more prominent effect compare to low-intensity exercise.

Study Overview

• Status: Completed
• Conditions: Psychotic Disorders; Schizophrenia and Related Disorders
• Intervention / Treatment: Other: Exercise; Other: Non-exercise

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Aged from 18 to 55
• Based on the SCID diagnosed to have schizophrenia and related psychotic disorders
• Ability to understand the nature of the study and to give written informed consent

Exclusion Criteria:

• Severe physical illness (Myocardial Infarction, Hypertension, Fracture, Spinal problems in which exercise may be contraindicated), and seizure disorders
• Comorbid substance dependence
• Unstable psychotic symptoms
• A history of brain trauma or organic brain disease
• Known history of intellectual disability or special school attendance
• Answered one or more "yes" in the PAR-Q and without doctors approval for exercise

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: High-endurance group; This group of subjects will receive 2-3 sessions of high-intensity cycling exercise training per week, for a total of 12 weeks. The exercise the subjects received will interchange between the aerobic and anaerobic state.	Other: Exercise; Indoor cycling exercise intervention
EXPERIMENTAL: Low-endurance group; This group of subjects will receive 2-3 sessions of low-intensity cycling exercise training per week, for a total of 12 weeks. The exercise the subjects received will maintain at an aerobic level.	Other: Exercise; Indoor cycling exercise intervention
ACTIVE_COMPARATOR: Psycho-education; This group of subjects will receive 2-3 sessions of psycho-education class per week, for a total of 12 weeks. The content of the class includes non-exercise related psycho-education content to participants (e.g., food hygiene, psychological well being, food nutrition, etc).	Other: Non-exercise; Psycho-education

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The sleep-dependent procedural memory consolidation after 12 weeks of intervention	Tested by comparing the finger-tapping motor sequence task performance between the three groups during the 12-week follow-up assessment.	12-week Follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The verbal memory consolidation after 12 weeks of intervention	Tested by comparing the logical memory task performance between the three groups during the 12-week follow-up assessment	12-week Follow-up
The attention performance after 12 weeks of intervention	Measured by using the cancellation task performance and compare between the three groups during the 12-week follow-up assessment	12-week Follow-up
The sleep quality after 12 weeks of intervention	Measured by using the Pittsburgh Sleep Quality Index (PSQI) and compare the differences between the three groups during the 12-week follow-up assessment	12-week Follow-up
The insomnia severity after 12 weeks of intervention	Measured by using the Insomnia Severity Index (ISI) and compare the differences between the three groups during the 12-week follow-up assessment	12-week Follow-up

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Investigators: Principal Investigator: Lik Hang Lincoln Lo, The University of Hong Kong

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 21, 2016
• Primary Completion (ACTUAL): September 1, 2017
• Study Completion (ACTUAL): September 1, 2017

Study Registration Dates

• First Submitted: January 3, 2019
• First Submitted That Met QC Criteria: January 8, 2019
• First Posted (ACTUAL): January 11, 2019

Study Record Updates

• Last Update Posted (ACTUAL): January 11, 2019
• Last Update Submitted That Met QC Criteria: January 8, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Exercise; Aerobic; Anaerobic; Sleep-dependent memory consolidation
• Additional Relevant MeSH Terms: Pathologic Processes; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Disease; Psychotic Disorders; Mental Disorders
• Other Study ID Numbers: HKU_Psych

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No