search
Back to results

Online Exercise Intervention for Psychosis Patients Receiving Residential Care

Primary Purpose

Psychosis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Online exercise
SMS message
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Psychosis

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Hong Kong

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Online exercise

SMS message

Arm Description

SMS messages on encouraging active lifestyle plus an online exercise video

SMS messages on encouraging active lifestyle

Outcomes

Primary Outcome Measures

Exercise level
Measured by the International Physical Activity Questionnaire, a higher MET calculated from the scale indicates a higher exercise level

Secondary Outcome Measures

Severity of psychotic symptoms
Measured by the Positive and Negative Syndrome Scale, a higher score indicates a more severe level of psychotic symptoms

Full Information

First Posted
November 16, 2020
Last Updated
May 22, 2022
Sponsor
The University of Hong Kong
search

1. Study Identification

Unique Protocol Identification Number
NCT04631952
Brief Title
Online Exercise Intervention for Psychosis Patients Receiving Residential Care
Official Title
A Randomised Controlled Trial of Online Exercise Intervention for Psychosis Patients Receiving Residential Care in Hong Kong
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2022 (Anticipated)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)

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
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychosis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Online exercise
Arm Type
Experimental
Arm Description
SMS messages on encouraging active lifestyle plus an online exercise video
Arm Title
SMS message
Arm Type
Active Comparator
Arm Description
SMS messages on encouraging active lifestyle
Intervention Type
Behavioral
Intervention Name(s)
Online exercise
Intervention Description
SMS messeages on encouraging active lifestyle and online exercise video will be sent to the participant weekly for 8 weeks.
Intervention Type
Behavioral
Intervention Name(s)
SMS message
Intervention Description
SMS messeages on encouraging active lifestyle will be sent to the participant weekly for 8 weeks.
Primary Outcome Measure Information:
Title
Exercise level
Description
Measured by the International Physical Activity Questionnaire, a higher MET calculated from the scale indicates a higher exercise level
Time Frame
6 months and 12 months
Secondary Outcome Measure Information:
Title
Severity of psychotic symptoms
Description
Measured by the Positive and Negative Syndrome Scale, a higher score indicates a more severe level of psychotic symptoms
Time Frame
6 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yi Nam Suen, PhD
Phone
39179579
Email
suenyn@hku.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yi Nam Suen, PhD
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Hong Kong
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Online Exercise Intervention for Psychosis Patients Receiving Residential Care

We'll reach out to this number within 24 hrs