Online Exercise Intervention for Psychosis Patients Receiving Residential Care

Psychosis Clinical Trial

Official title:

A Randomised Controlled Trial of Online Exercise Intervention for Psychosis Patients Receiving Residential Care in Hong Kong

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04631952
• Other study ID #: SMI_exercise_RCT
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: June 1, 2024

Study information

• Verified date: May 2022
• Source: The University of Hong Kong
• Contact: Yi Nam Suen, PhD
• Phone: 39179579
• Email: suenyn[@]hku.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 180
• Est. completion date: June 1, 2024
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

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.

Related Conditions & MeSH terms

• Mental Disorders
• Psychosis
• Psychotic Disorders

Intervention

Behavioral:
• Online exercise
SMS messeages on encouraging active lifestyle and online exercise video will be sent to the participant weekly for 8 weeks.
• SMS message
SMS messeages on encouraging active lifestyle will be sent to the participant weekly for 8 weeks.

Locations

Country	Name	City	State
Hong Kong	University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exercise level	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	Severity of psychotic symptoms	Measured by the Positive and Negative Syndrome Scale, a higher score indicates a more severe level of psychotic symptoms	6 and 12 months