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Exercise and Overnight Motor Sequence Task (EOMST)

Primary Purpose

Schizophrenia and Related Disorders, Psychotic Disorders

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Exercise
Non-exercise
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia and Related Disorders focused on measuring Exercise, Sleep-dependent memory consolidation, Aerobic, Anaerobic

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Arm Label

    High-endurance group

    Low-endurance group

    Psycho-education

    Arm Description

    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.

    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.

    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).

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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
    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
    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
    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

    Full Information

    First Posted
    January 3, 2019
    Last Updated
    January 8, 2019
    Sponsor
    The University of Hong Kong
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03800368
    Brief Title
    Exercise and Overnight Motor Sequence Task
    Acronym
    EOMST
    Official Title
    12-week Aerobic-Anaerobic Transition Exercise Intervention and Overnight Sleep-dependent Procedural Memory Consolidation in Patients With Schizophrenia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    December 21, 2016 (Actual)
    Primary Completion Date
    September 1, 2017 (Actual)
    Study Completion Date
    September 1, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    The University of Hong Kong

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Schizophrenia and Related Disorders, Psychotic Disorders
    Keywords
    Exercise, Sleep-dependent memory consolidation, Aerobic, Anaerobic

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    51 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    High-endurance group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Low-endurance group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Psycho-education
    Arm Type
    Active Comparator
    Arm Description
    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).
    Intervention Type
    Other
    Intervention Name(s)
    Exercise
    Intervention Description
    Indoor cycling exercise intervention
    Intervention Type
    Other
    Intervention Name(s)
    Non-exercise
    Intervention Description
    Psycho-education
    Primary Outcome Measure Information:
    Title
    The sleep-dependent procedural memory consolidation after 12 weeks of intervention
    Description
    Tested by comparing the finger-tapping motor sequence task performance between the three groups during the 12-week follow-up assessment.
    Time Frame
    12-week Follow-up
    Secondary Outcome Measure Information:
    Title
    The verbal memory consolidation after 12 weeks of intervention
    Description
    Tested by comparing the logical memory task performance between the three groups during the 12-week follow-up assessment
    Time Frame
    12-week Follow-up
    Title
    The attention performance after 12 weeks of intervention
    Description
    Measured by using the cancellation task performance and compare between the three groups during the 12-week follow-up assessment
    Time Frame
    12-week Follow-up
    Title
    The sleep quality after 12 weeks of intervention
    Description
    Measured by using the Pittsburgh Sleep Quality Index (PSQI) and compare the differences between the three groups during the 12-week follow-up assessment
    Time Frame
    12-week Follow-up
    Title
    The insomnia severity after 12 weeks of intervention
    Description
    Measured by using the Insomnia Severity Index (ISI) and compare the differences between the three groups during the 12-week follow-up assessment
    Time Frame
    12-week Follow-up

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Lik Hang Lincoln Lo
    Organizational Affiliation
    The University of Hong Kong
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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