NCT03800368

Brief Summary

The objective of this randomized controlled trial (RCT) is to compare the changes of the sleep-related memory functions in patients with psychosis after they have completed the 12-week high-intensity exercise intervention, the 12-week low-intensity exercise intervention, or the 12-week controlled non-exercise intervention respectively. Fifty-one patients with psychosis, patients who received either the high-intensity exercise or low-intensity exercise as intervention shown a significant improvement to their impaired sleep-related memory function, while those who received non-exercise intervention has no such improvement. Moreover, high-intensity exercise may have a more prominent effect compare to low-intensity exercise.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2016

Shorter than P25 for not_applicable

Status
completed

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

Study Start

First participant enrolled

December 21, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

January 3, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 11, 2019

Completed
Last Updated

January 11, 2019

Status Verified

January 1, 2019

Enrollment Period

8 months

First QC Date

January 3, 2019

Last Update Submit

January 8, 2019

Conditions

Keywords

ExerciseSleep-dependent memory consolidationAerobicAnaerobic

Outcome Measures

Primary Outcomes (1)

  • The sleep-dependent procedural memory consolidation after 12 weeks of intervention

    Tested by comparing the finger-tapping motor sequence task performance between the three groups during the 12-week follow-up assessment.

    12-week Follow-up

Secondary Outcomes (4)

  • The verbal memory consolidation after 12 weeks of intervention

    12-week Follow-up

  • The attention performance after 12 weeks of intervention

    12-week Follow-up

  • The sleep quality after 12 weeks of intervention

    12-week Follow-up

  • The insomnia severity after 12 weeks of intervention

    12-week Follow-up

Study Arms (3)

High-endurance group

EXPERIMENTAL

This group of subjects will receive 2-3 sessions of high-intensity cycling exercise training per week, for a total of 12 weeks. The exercise the subjects received will interchange between the aerobic and anaerobic state.

Other: Exercise

Low-endurance group

EXPERIMENTAL

This group of subjects will receive 2-3 sessions of low-intensity cycling exercise training per week, for a total of 12 weeks. The exercise the subjects received will maintain at an aerobic level.

Other: Exercise

Psycho-education

ACTIVE COMPARATOR

This group of subjects will receive 2-3 sessions of psycho-education class per week, for a total of 12 weeks. The content of the class includes non-exercise related psycho-education content to participants (e.g., food hygiene, psychological well being, food nutrition, etc).

Other: Non-exercise

Interventions

Indoor cycling exercise intervention

High-endurance groupLow-endurance group

Psycho-education

Psycho-education

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Aged from 18 to 55
  • Based on the SCID diagnosed to have schizophrenia and related psychotic disorders
  • Ability to understand the nature of the study and to give written 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
  • A history of brain trauma or organic brain disease
  • Known history of intellectual disability or special school attendance
  • Answered one or more "yes" in the PAR-Q and without doctors approval for exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Lo LLH, Lee EHM, Hui CLM, Chong CSY, Chang WC, Chan SKW, Lin JJ, Lo WTL, Chen EYH. Effect of high-endurance exercise intervention on sleep-dependent procedural memory consolidation in individuals with schizophrenia: a randomized controlled trial. Psychol Med. 2023 Apr;53(5):1708-1720. doi: 10.1017/S0033291721003196. Epub 2021 Oct 7.

MeSH Terms

Conditions

SchizophreniaPsychotic DisordersMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Lik Hang Lincoln Lo

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postdoctoral Fellow

Study Record Dates

First Submitted

January 3, 2019

First Posted

January 11, 2019

Study Start

December 21, 2016

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

January 11, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share