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Online Exercise Intervention for Psychosis Patients Receiving Residential Care

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ClinicalTrials.gov Identifier: NCT04631952
Recruitment Status : Not yet recruiting
First Posted : November 17, 2020
Last Update Posted : May 24, 2022
Sponsor:
Information provided by (Responsible Party):
Dr. Yi-Nam Suen, The University of Hong Kong

Study Description
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Brief Summary:
The main objective of this randomised controlled trial (RCT) is to investigate the immediate and long-term effectiveness of 8-week online exercise intervention for people with psychosis receiving residential care.

Condition or disease Intervention/treatment Phase
Psychosis Behavioral: Online exercise Behavioral: SMS message Not Applicable

Detailed Description:

The effect will also be evaluated after 6-month and 12-month, anticipate seeing the maintenance of physical activity throughout a year of time.

The secondary objective of this RCT is to investigate if the exercise intervention will be effective in improving the clinical symptoms, cognitive functioning and social functioning of the subjects, and to see if the improvement can be maintained (or improve) over a longer period of time (i.e., 6-month and 12-month).

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Randomised Controlled Trial of Online Exercise Intervention for Psychosis Patients Receiving Residential Care in Hong Kong
Estimated Study Start Date : December 1, 2022
Estimated Primary Completion Date : December 1, 2023
Estimated Study Completion Date : June 1, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Online exercise
SMS messages on encouraging active lifestyle plus an online exercise video
 Behavioral: Online exercise
SMS messeages on encouraging active lifestyle and online exercise video will be sent to the participant weekly for 8 weeks.
Active Comparator: SMS message
SMS messages on encouraging active lifestyle
 Behavioral: SMS message
SMS messeages on encouraging active lifestyle will be sent to the participant weekly for 8 weeks.


Outcome Measures
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Primary Outcome Measures :
  1. Exercise level [ Time Frame: 6 months and 12 months ]
    Measured by the International Physical Activity Questionnaire, a higher MET calculated from the scale indicates a higher exercise level


Secondary Outcome Measures :
  1. Severity of psychotic symptoms [ Time Frame: 6 and 12 months ]
    Measured by the Positive and Negative Syndrome Scale, a higher score indicates a more severe level of psychotic symptoms


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Based on the Fifth version of the Diagnostic and Statistical Manual of Mental Disorders diagnosis to have schizophrenia and related psychotic disorders
  • Have the ability to understand Chinese
  • Able to give 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
  • Any history of brain trauma or organic brain disease
  • Known history of intellectual disability or special school attendance
  • Other mental conditions that requires other treatment priorities, e.g., suicidal risk.
  • Other medical conditions that severely limits participation, comprehension, or adherence to the treatment or assessment e.g., epilepsy, dementia, terminal medical illness.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04631952


Contacts
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Contact: Yi Nam Suen, PhD 39179579 suenyn@hku.hk

Locations
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Hong Kong
University of Hong Kong
Hong Kong, Hong Kong
Sponsors and Collaborators
The University of Hong Kong
Investigators
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Principal Investigator: Yi Nam Suen, PhD The University of Hong Kong
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Dr. Yi-Nam Suen, Research Assistant Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT04631952    
Other Study ID Numbers: SMI_exercise_RCT
First Posted: November 17, 2020    Key Record Dates
Last Update Posted: May 24, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders