PsychosisNCT04631952
Online Exercise Intervention for Psychosis Patients Receiving Residential Care
A study testing Online exercise and SMS message in people with Psychosis, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Psychosis
- What is being tested?
- Online exercise and SMS message
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Dec 2022to 1 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Psychosis
- Being tested
- Online exercise, SMS message
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online exerciseBehavioural
SMS messeages on encouraging active lifestyle and online exercise video will be sent to the participant weekly for 8 weeks.
SMS messageBehavioural
SMS messeages on encouraging active lifestyle will be sent to the participant weekly for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Online exercise | Experimental | SMS messages on encouraging active lifestyle plus an online exercise video Receives: Behavioral: Online exercise |
| SMS message | Active comparator | SMS messages on encouraging active lifestyle Receives: Behavioral: SMS message |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise level
Measured by the International Physical Activity Questionnaire, a higher MET calculated from the scale indicates a higher exercise level
Measured: 6 months and 12 months
Secondary outcomes (1)
Severity of psychotic symptoms
Measured by the Positive and Negative Syndrome Scale, a higher score indicates a more severe level of psychotic symptoms
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2020
- Study start1 Dec 2022 (estimated)
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsychosisStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Yi-Nam Suen, The University of Hong Kong
- Investigators
- Yi Nam Suen, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04631952
- Sponsor's protocol ID
- SMI_exercise_RCT
- Status last verified
- May 2022
- First submitted
- 16 Nov 2020
- Last updated
- 24 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial of Online Exercise Intervention for Psychosis Patients Receiving Residential Care in Hong Kong
- ClinicalTrials.gov ID
- NCT04631952
- Acronym / sponsor ID
- SMI_exercise_RCT
- Conditions
- Psychosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Dec 2022 (estimated)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 17 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Online exercise | Experimental | Behavioral: Online exerciseSMS messages on encouraging active lifestyle plus an online exercise video |
| SMS message | Active comparator | Behavioral: SMS messageSMS messages on encouraging active lifestyle |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online exerciseSMS messeages on encouraging active lifestyle and online exercise video will be sent to the participant weekly for 8 weeks. | Behavioural | Online exercise |
| SMS messageSMS messeages on encouraging active lifestyle will be sent to the participant weekly for 8 weeks. | Behavioural | SMS message |
Primary outcome
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
1 secondary outcome
Severity of psychotic symptoms
Time frame: 6 and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yi Nam Suen, PhD principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online exercise and SMS message in people with Psychosis, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yi Nam Suen, PhD (39179579, suenyn@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise level (time frame: 6 months and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2022.