NCT04631952

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 16, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 17, 2020

Completed
2 years until next milestone

Study Start

First participant enrolled

December 1, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

May 24, 2022

Status Verified

May 1, 2022

Enrollment Period

1 year

First QC Date

November 16, 2020

Last Update Submit

May 22, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Severity of psychotic symptoms

    6 and 12 months

Study Arms (2)

Online exercise

EXPERIMENTAL

SMS messages on encouraging active lifestyle plus an online exercise video

Behavioral: Online exercise

SMS message

ACTIVE COMPARATOR

SMS messages on encouraging active lifestyle

Behavioral: SMS message

Interventions

Online exerciseBEHAVIORAL

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

Online exercise
SMS messageBEHAVIORAL

SMS messeages on encouraging active lifestyle will be sent to the participant weekly for 8 weeks.

SMS message

Eligibility Criteria

Age18 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Yi Nam Suen, PhD

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi Nam Suen, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant Professor

Study Record Dates

First Submitted

November 16, 2020

First Posted

November 17, 2020

Study Start

December 1, 2022

Primary Completion

December 1, 2023

Study Completion

June 1, 2024

Last Updated

May 24, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations