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Online Exercise Intervention for Psychosis Patients Receiving Residential Care

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE November 16, 2020
First Posted Date  ICMJE November 17, 2020
Last Update Posted Date May 24, 2022
Estimated Study Start Date  ICMJE December 1, 2022
Estimated Primary Completion Date December 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 16, 2020)		 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
Original Primary Outcome Measures  ICMJE
 (submitted: November 16, 2020)		 Exercise level [ Time Frame: 6 months and 12 months ]
Measured by the International Physical Activity Questionnaire
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 16, 2020)		 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
Original Secondary Outcome Measures  ICMJE
 (submitted: November 16, 2020)		 Severity of psychotic symptoms [ Time Frame: 6 and 12 months ]
Measured by the Positive and Negative Syndrome Scale
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Online Exercise Intervention for Psychosis Patients Receiving Residential Care
Official Title  ICMJE A Randomised Controlled Trial of Online Exercise Intervention for Psychosis Patients Receiving Residential Care in Hong Kong
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Psychosis
Intervention  ICMJE
  • Behavioral: Online exercise
    SMS messeages on encouraging active lifestyle and online exercise video will be sent to the participant weekly for 8 weeks.
  • Behavioral: SMS message
    SMS messeages on encouraging active lifestyle will be sent to the participant weekly for 8 weeks.
Study Arms  ICMJE
  • Experimental: Online exercise
    SMS messages on encouraging active lifestyle plus an online exercise video
    Intervention: Behavioral: Online exercise
  • Active Comparator: SMS message
    SMS messages on encouraging active lifestyle
    Intervention: Behavioral: SMS message
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: November 16, 2020)		 180
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 1, 2024
Estimated Primary Completion Date December 1, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 69 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Yi Nam Suen, PhD 39179579 suenyn@hku.hk
Listed Location Countries  ICMJE Hong Kong
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04631952
Other Study ID Numbers  ICMJE SMI_exercise_RCT
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Dr. Yi-Nam Suen, The University of Hong Kong
Original Responsible Party Same as current
Current Study Sponsor  ICMJE The University of Hong Kong
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Yi Nam Suen, PhD The University of Hong Kong
PRS Account The University of Hong Kong
Verification Date May 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP