Schizophrenia and Related DisordersEOMSTNCT03800368
Exercise and Overnight Motor Sequence Task
A study testing Exercise and Non-exercise in people with Schizophrenia and Related Disorders and Psychotic Disorders, run by The University of Hong Kong.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Schizophrenia and Related Disorders, Psychotic Disorders
- What is being tested?
- Exercise and Non-exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- No sites listed yet
- Study dates
- 21 Dec 2016to 1 Sep 2017
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
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
- 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
About this study
Official title: 12-week Aerobic-Anaerobic Transition Exercise Intervention and Overnight Sleep-dependent Procedural Memory Consolidation in Patients With Schizophrenia
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.
- Being tested
- Exercise, Non-exercise
- Keywords
- Exercise, Sleep-dependent memory consolidation, Aerobic, Anaerobic
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Indoor cycling exercise intervention
Non-exerciseOther
Psycho-education
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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). Receives: Other: Non-exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12-week Follow-up
Secondary outcomes (4)
The verbal memory consolidation after 12 weeks of intervention
Tested by comparing the logical memory task performance between the three groups during the 12-week follow-up assessment
Measured: 12-week Follow-up
The attention performance after 12 weeks of intervention
Measured by using the cancellation task performance and compare between the three groups during the 12-week follow-up assessment
Measured: 12-week Follow-up
The sleep quality after 12 weeks of intervention
Measured by using the Pittsburgh Sleep Quality Index (PSQI) and compare the differences between the three groups during the 12-week follow-up assessment
Measured: 12-week Follow-up
The insomnia severity after 12 weeks of intervention
Measured by using the Insomnia Severity Index (ISI) and compare the differences between the three groups during the 12-week follow-up assessment
Measured: 12-week Follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2019
- Study start21 Dec 2016
- Primary completion1 Sep 2017
- Study completion1 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Schizophrenia and Related DisordersStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Lincoln Lik-Hang Lo, The University of Hong Kong
- Investigators
- Lik Hang Lincoln Lo, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03800368
- Sponsor's protocol ID
- HKU_Psych
- Acronym
- EOMST
- Status last verified
- Jan 2019
- First submitted
- 3 Jan 2019
- Last updated
- 11 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34615565
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 12-week Aerobic-Anaerobic Transition Exercise Intervention and Overnight Sleep-dependent Procedural Memory Consolidation in Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT03800368
- Acronym / sponsor ID
- EOMST / HKU_Psych
- Keywords
- Exercise, Sleep-dependent memory consolidation, Aerobic, Anaerobic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 21 Dec 2016 (actual)
- Primary completion
- 1 Sep 2017 (actual)
- Study completion
- 1 Sep 2017 (actual)
- First posted
- 11 Jan 2019 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High-endurance group | Experimental | Other: ExerciseThis 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. |
| Low-endurance group | Experimental | Other: ExerciseThis 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. |
| Psycho-education | Active comparator | Other: Non-exerciseThis 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). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 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
- A 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 |
|---|---|---|
| ExerciseIndoor cycling exercise intervention | Other | High-endurance group, Low-endurance group |
| Non-exercisePsycho-education | Other | Psycho-education |
Primary outcome
The sleep-dependent procedural memory consolidation after 12 weeks of intervention
Time frame: 12-week Follow-up
Tested by comparing the finger-tapping motor sequence task performance between the three groups during the 12-week follow-up assessment.
4 secondary outcomes
The verbal memory consolidation after 12 weeks of intervention
Time frame: 12-week Follow-up
The attention performance after 12 weeks of intervention
Time frame: 12-week Follow-up
The sleep quality after 12 weeks of intervention
Time frame: 12-week Follow-up
The insomnia severity after 12 weeks of intervention
Time frame: 12-week Follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2019.
- Derived from this study: PubMed 34615565Lo 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.
- 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.
Lik Hang Lincoln Lo principal investigator
The University of Hong Kong
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and Non-exercise in people with Schizophrenia and Related Disorders and Psychotic Disorders, run by The University of 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 6 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: finished, as of the sponsor's last update on 11 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The sleep-dependent procedural memory consolidation after 12 weeks of intervention (time frame: 12-week Follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03800368, which also lists 1 linked publication.
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 11 Jan 2019.