SchizophreniaNCT04411979
Effects of 12 Weeks Walking on Cognitive Function in Schizophrenia
A study testing treatment-as-usual plus aerobic walking in people with Schizophrenia, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
This study is a 12-week randomized-controlled clinical trial. It will be planned to conduct in a total of 120 male and female subjects from the Department of Psychiatry at Kaohsiung Chang Gung Memorial Hospital. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- treatment-as-usual plus aerobic walking
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteTaiwan
- Study dates
- 27 Sep 2018to 15 Oct 2019
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient has been diagnosed of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, fifth edition criteria (DSM-5) criteria
- The patient has the ability to complete the written informed consent
Who cannot join
- The patient has been diagnosed with organic mental disorders, intelligence disability, dementia, major depressive disorder, bipolar affective disorder, and alcohol or substance use disorder
- The patient has major systemic physical diseases, including cardiovascular diseases, uncontrollable arrhythmia, renal diseases, liver diseases or thyroid diseases
- The patient has certified as physical disability
- The patient is pregnant or has genetic diseases or infectious conditions
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Psychiatry, Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City
About this study
Official title: Cognitive Function and Energy Metabolites in Schizophrenia: the Effect of Wearable Device-assisted Walking
This study is a 12-week randomized-controlled clinical trial. It will be planned to conduct in a total of 120 male and female subjects from the Department of Psychiatry at Kaohsiung Chang Gung Memorial Hospital. Eligible subjects will be psychiatric patients, aged between 20-65 years old, who have psychiatric diagnosis of schizophrenia and fulfill the inclusion and exclusion criteria. The intervention with aerobic walking programs will be initiated after randomization for patients who continue their usual treatment. Subjects will be enrolled for 12 weeks aerobic walking treatment and randomly assigned to (1) treatment-as-usual, (2) treatment-as-usual plus aerobic walking. We will measure the treatment response to clarify the effect of aerobic walking in patients with schizophrenia. This study is being performed to investigate the possibly beneficial effects of aerobic walking on cognitive function and energy metabolites in schizophrenia.
Read the detailed description
This 12-week randomized-controlled clinical trial will be planned to conduct in a total of 120 male and female subjects from the Department of Psychiatry at Kaohsiung Chang Gung Memorial Hospital. Eligible subjects will be psychiatric patients, aged between 20-65 years old, who have psychiatric diagnosis of schizophrenia and fulfill the inclusion and exclusion criteria. The intervention with aerobic walking programs will be initiated after randomization for patients who continue their usual treatment. Subjects will be enrolled for 12 weeks aerobic walking treatment and randomly assigned to (1) treatment-as-usual, (2) treatment-as-usual plus aerobic walking. The wearable watch will be used during the participants join the walking programs. We will measure the treatment response to investigate the effect of aerobic walking in patients with schizophrenia. This study is being performed to investigate the possibly beneficial effects of aerobic walking on cognitive function in schizophrenia.
- Conditions
- Schizophrenia
- Being tested
- treatment-as-usual plus aerobic walking
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
treatment-as-usual plus aerobic walkingOther
aerobic walking
| Study group | Role | What they receive |
|---|---|---|
| treatment-as-usual | No intervention | Not described |
| treatment-as-usual plus aerobic walking | Experimental | Not described Receives: Other: treatment-as-usual plus aerobic walking |
What is being measured
The primary outcome is the main question the study is designed to answer.
cognitive function change
cognitive function change assessed by Brief Assessment of Cognition in Schizophrenia
Measured: week 12
treatment change assessed by serum levels of energy metabolites (e.g., β-hydroxybutyrate)
change assessment
Measured: week 12
Secondary outcomes (5)
treatment change assessed by the Positive and Negative Syndrome Scale
minimum value 30, maximum value 210; higher scores mean a worse outcome
Measured: week 12
treatment change assessed by peripheral blood metabolic profiles (e.g., plasma cholesterol level)
change assessment
Measured: week 12
treatment change assessed by metabolic profiles (e.g., body weight in kilograms)
change assessment
Measured: week 6, week 12
treatment change assessed by serum levels of inflammatory cytokines (e.g., IL-8)
change assessment
Measured: week 12
treatment change assessed by 6-minute walk test
change assessment
Measured: week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2020
- Study start27 Sep 2018
- Primary completion17 Jul 2019
- Study completion15 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- 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
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan
- Responsible party
- Sponsor
- Investigators
- Yu-Chi Huang, MD, Principal investigator, Department of Psychiatry, Kaohsiung Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04411979
- Sponsor's protocol ID
- MOST 107-2635-B-182A-002
- Other IDs
- 201702283A3C601
- Status last verified
- Feb 2018
- First submitted
- 22 May 2020
- Last updated
- 2 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Function and Energy Metabolites in Schizophrenia: the Effect of Wearable Device-assisted Walking
- ClinicalTrials.gov ID
- NCT04411979
- Acronym / sponsor ID
- MOST 107-2635-B-182A-002
- Conditions
- Schizophrenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan
- Study start
- 27 Sep 2018 (actual)
- Primary completion
- 17 Jul 2019 (actual)
- Study completion
- 15 Oct 2019 (actual)
- First posted
- 2 Jun 2020 (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.
This study is a 12-week randomized-controlled clinical trial. It will be planned to conduct in a total of 120 male and female subjects from the Department of Psychiatry at Kaohsiung Chang Gung Memorial Hospital. Eligible subjects will be psychiatric patients, aged between 20-65 years old, who have psychiatric diagnosis of schizophrenia and fulfill the inclusion and exclusion criteria. The intervention with aerobic walking programs will be initiated after randomization for patients who continue their usual treatment. Subjects will be enrolled for 12 weeks aerobic walking treatment and randomly assigned to (1) treatment-as-usual, (2) treatment-as-usual plus aerobic walking. We will measure the treatment response to clarify the effect of aerobic walking in patients with schizophrenia. This study is being performed to investigate the possibly beneficial effects of aerobic walking on cognitive function and energy metabolites in schizophrenia.
Detailed description
This 12-week randomized-controlled clinical trial will be planned to conduct in a total of 120 male and female subjects from the Department of Psychiatry at Kaohsiung Chang Gung Memorial Hospital. Eligible subjects will be psychiatric patients, aged between 20-65 years old, who have psychiatric diagnosis of schizophrenia and fulfill the inclusion and exclusion criteria. The intervention with aerobic walking programs will be initiated after randomization for patients who continue their usual treatment. Subjects will be enrolled for 12 weeks aerobic walking treatment and randomly assigned to (1) treatment-as-usual, (2) treatment-as-usual plus aerobic walking. The wearable watch will be used during the participants join the walking programs. We will measure the treatment response to investigate the effect of aerobic walking in patients with schizophrenia. This study is being performed to investigate the possibly beneficial effects of aerobic walking on cognitive function in schizophrenia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment-as-usual | No intervention | – |
| treatment-as-usual plus aerobic walking | Experimental | Other: treatment-as-usual plus aerobic walking |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- The patient has been diagnosed of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, fifth edition criteria (DSM-5) criteria
- The patient has the ability to complete the written informed consent
Key exclusion criteria (4 listed)
- The patient has been diagnosed with organic mental disorders, intelligence disability, dementia, major depressive disorder, bipolar affective disorder, and alcohol or substance use disorder
- The patient has major systemic physical diseases, including cardiovascular diseases, uncontrollable arrhythmia, renal diseases, liver diseases or thyroid diseases
- The patient has certified as physical disability
- The patient is pregnant or has genetic diseases or infectious conditions
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 |
|---|---|---|
| treatment-as-usual plus aerobic walkingaerobic walking | Other | treatment-as-usual plus aerobic walking |
Primary outcome
cognitive function change
Time frame: week 12
cognitive function change assessed by Brief Assessment of Cognition in Schizophrenia
treatment change assessed by serum levels of energy metabolites (e.g., β-hydroxybutyrate)
Time frame: week 12
change assessment
5 secondary outcomes
treatment change assessed by the Positive and Negative Syndrome Scale
Time frame: week 12
treatment change assessed by peripheral blood metabolic profiles (e.g., plasma cholesterol level)
Time frame: week 12
treatment change assessed by metabolic profiles (e.g., body weight in kilograms)
Time frame: week 6, week 12
treatment change assessed by serum levels of inflammatory cytokines (e.g., IL-8)
Time frame: week 12
treatment change assessed by 6-minute walk test
Time frame: week 12
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 2 Jun 2020.
- 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.
Yu-Chi Huang, MD principal investigator
Department of Psychiatry, Kaohsiung Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing treatment-as-usual plus aerobic walking in people with Schizophrenia, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 2 inclusion and 4 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 2 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
cognitive function change (time frame: week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jun 2020.