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

  • Hong Kong
      • Hong Kong, Hong Kong
        • University of Hong Kong

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
Behavioral: Online exercise
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
Behavioral: SMS message
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

The University of Hong Kong

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.

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