Online Exercise Intervention for Psychosis Patients Receiving Residential Care
May 22, 2022 updated by: Dr. Yi-Nam Suen, The University of Hong Kong
A Randomised Controlled Trial of Online Exercise Intervention for Psychosis Patients Receiving Residential Care in Hong Kong
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Anticipated)
180
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yi Nam Suen, PhD
- Phone Number: 39179579
- Email: suenyn@hku.hk
Study Locations
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-
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Hong Kong, Hong Kong
- University of Hong Kong
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 69 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Online exercise
SMS messages on encouraging active lifestyle plus an online exercise video
|
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
|
SMS messeages on encouraging active lifestyle will be sent to the participant weekly for 8 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
6 months and 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
6 and 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
December 1, 2022
Primary Completion (Anticipated)
December 1, 2023
Study Completion (Anticipated)
June 1, 2024
Study Registration Dates
First Submitted
November 16, 2020
First Submitted That Met QC Criteria
November 16, 2020
First Posted (Actual)
November 17, 2020
Study Record Updates
Last Update Posted (Actual)
May 24, 2022
Last Update Submitted That Met QC Criteria
May 22, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SMI_exercise_RCT
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.