SchizophreniaNCT05341804
Cognitive and Balance Dual Task Training for People With Schizophrenia
A study testing cognitive and balance dual task training and balance training in people with Schizophrenia and Cognition, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial summary
After developing and pilot testing the training program, including the CogBals software, a 3-arm, single-blinded, randomized controlled trial is used to recruit 84 participants and then randomly allocated to the cognitive and balance dual task training group (COG\&BAL), the balance training group (BAL), and the… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Schizophrenia, Cognition, Balance
- What is being tested?
- cognitive and balance dual task training and balance training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteTaiwan
- Study dates
- 10 May 2022to 15 Sep 2023
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of schizophrenia or schizoaffective disorder for more than 1 year by psychiatrist according to Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5)
- age 40-75 years old
- have stable psychiatric symptoms currently (main psychotropic medications have not been adjusted for two months
- being able to ambulate independently for more than 10 meters, without a walking device
- not have significant cognitive impairment (Montreal Cognitive Assessment Taiwan Version, MoCA≧20)
- can follow study protocol and sign the informed consent form
Who cannot join
- currently in the psychiatric acute award
- currently alcohol or drug use disorder
- Pregnancy, head trauma and other neuromusculoskeletal injuries affect training safety and compliance
- intellectual disability
- Unconsciousness or confusion
- According to the subject's self-report, those with the following medical history, including severe heart failure, myocardial infarction, angina pectoris, chronic obstructive pulmonary disease, poor blood sugar control (i.e., renal dialysis treatment, diabetic neuropathy or retinopathy), no well-controlled hyperemia: systolic blood pressure> 160 mmHg or diastolic blood pressure> 110 mmHg
- Currently participating in other interventional study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cognitive and Balance Dual Task Training for People With Schizophrenia - Program System Development and Effectiveness Analysis
After developing and pilot testing the training program, including the CogBals software, a 3-arm, single-blinded, randomized controlled trial is used to recruit 84 participants and then randomly allocated to the cognitive and balance dual task training group (COG\&BAL), the balance training group (BAL), and the treatment as usual group. The first two training groups (COG\&BAL, BAL) receive training for 60 minutes in a group format, 2 times weekly, for 12 weeks. All participants will be assessed at baseline and posttest. The primary outcome is balance function and secondary outcomes are cognitive functions and the muscular endurance of lower extremities.
Read the detailed description
Background: Individuals with schizophrenia often experience premature aging and accelerated aging, which increases the challenge of care and recovery. Improvement on balance and implementation of prevention from and deceleration of the disability process is of the critical issues in psychiatric rehabilitation. Unfortunately, evidence- based effective programs are limited. Recently, a novel balance training program through cognitive and balance dual task training has shown better outcomes in the elderly and other clinical populations. Yet, the dual task balance training has not been examined for schizophrenia. This dual task balance training with the Internet of Thing techniques is a novel and important program for middle-aged and older individuals with schizophrenia. Further study is needed to develop the training program and to examine the effectiveness.
Purposes: (1) To develop a cognitive and balance dual task training program involving the Internet of Thing technique software - Cognitive and Balance training Simultaneously software (CogBals software) (1st year); (2) to pilot the feasibility of the balance training program for the middle-aged and older individuals with schizophrenia and revise it (1st year); and (3) to examine the effects of the balance training program on balance, cognitive functions, and the muscular endurance of lower extremities (2nd to 3rd year).
Methods: For the effectiveness analysis phase, a 3-arm, single-blinded, randomized controlled trial is used to recruit 84 participants and then randomly allocated to the cognitive and balance dual task training group (COG\&BAL), the balance training group (BAL), and the treatment as usual group. The first two training groups (COG\&BAL, BAL) receive training for 60 minutes in a group format, 2 times weekly, for 12 weeks. All participants will be assessed at baseline and posttest. The primary outcome is balance function and secondary outcomes are cognitive functions and the muscular endurance of lower extremities.
Contribution: The study uses cognitive and balance dual task training and expect better outcomes on balance improvement. The program can serve as an evidence- based program to prevent and to decelerate the disability process from people with mental illness. The CogBals software developed by researchers and training in a group format is good to promote in the clinical setting with less manpower.
- Conditions
- Schizophrenia, Cognition, Balance, Dual Task, Mental Illness, Psychiatric Disorder
- Being tested
- cognitive and balance dual task training, balance training
- Medical subject headings
- Schizophrenia, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive and balance dual task trainingBehavioural
Also called Use Cognitive and Balance training Simultaneously software (CogBals)
a cognitive and balance dual task training program involving the Internet of Thing technique software - Cognitive and Balance training Simultaneously software
balance trainingBehavioural
Includes static balance, dynamic balance and strength training
| Study group | Role | What they receive |
|---|---|---|
| the cognitive and balance dual task training group | Experimental | It is performed using the CogBals software, emphasizing the completion of cognitive tasks while performing balance/strength training during the training process. Receives: Behavioral: cognitive and balance dual task training |
| the balance training group | Experimental | Balance/strength training without cognitive challenges. Receives: Behavioral: balance training |
| the treatment as usual group | No intervention | Maintain usual rehabilitation activities. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini-Balance Evaluation System Test
score from 0-28; higher score is better
Measured: Change from baseline at 12 weeks
Timed up and go test under single and dual tasks
dual tasks include carrying a cup of water and calculation
Measured: Change from baseline at 12 weeks
Single leg stance test under single and dual tasks
dual tasks include carrying a cup of water and calculation
Measured: Change from baseline at 12 weeks
Chinese version of Activities-specific Balance Confidence Scale
score from 0-100; higher score is better
Measured: Change from baseline at 12 weeks
6 meter walk test
Measured: Change from baseline at 12 weeks
Secondary outcomes (7)
Symbol Coding
The participant writes as many answers as possible within 90 seconds.
Measured: Change from baseline at 12 weeks
Digit Span
score from 0-33; higher score is better
Measured: Change from baseline at 12 weeks
Spatial Span
score from 0-32; higher score is better
Measured: Change from baseline at 12 weeks
The Stroop Color and Word Test
The participant reads color words or names ink colors from different pages as quickly as possible within 45 seconds.
Measured: Change from baseline at 12 weeks
Color Trials Test
Color Trials 1 and Color Trials 2
Measured: Change from baseline at 12 weeks
30-second sit to stand test
The participant completes as many full stands as possible within 30 seconds.
Measured: Change from baseline at 12 weeks
Bilateral standing heel-rise test
The participant performs the maximum number of plantar flexions possible, until the point of voluntary fatigue, as fast as possible.
Measured: Change from baseline at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start10 May 2022
- Primary completion15 Sep 2023
- Study completion15 Sep 2023
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.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial HospitalThe 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
- Model description
- the cognitive and balance dual task training group (COG\&BAL), the balance training group (BAL), and the treatment as usual group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Kaohsiung Medical University, Ministry of Science and Technology, Taiwan
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05341804
- Sponsor's protocol ID
- KMUHIRB-F(I)-20210071
- Status last verified
- Apr 2024
- First submitted
- 5 Apr 2022
- Last updated
- 21 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive and Balance Dual Task Training for People With Schizophrenia - Program System Development and Effectiveness Analysis
- ClinicalTrials.gov ID
- NCT05341804
- Acronym / sponsor ID
- KMUHIRB-F(I)-20210071
- Conditions
- Schizophrenia, Cognition, Balance, Dual Task, Mental Illness, Psychiatric Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Collaborators
- Kaohsiung Medical University, Ministry of Science and Technology, Taiwan
- Study start
- 10 May 2022 (actual)
- Primary completion
- 15 Sep 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 22 Apr 2022 (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.
After developing and pilot testing the training program, including the CogBals software, a 3-arm, single-blinded, randomized controlled trial is used to recruit 84 participants and then randomly allocated to the cognitive and balance dual task training group (COG\&BAL), the balance training group (BAL), and the treatment as usual group. The first two training groups (COG\&BAL, BAL) receive training for 60 minutes in a group format, 2 times weekly, for 12 weeks. All participants will be assessed at baseline and posttest. The primary outcome is balance function and secondary outcomes are cognitive functions and the muscular endurance of lower extremities.
Detailed description
Background: Individuals with schizophrenia often experience premature aging and accelerated aging, which increases the challenge of care and recovery. Improvement on balance and implementation of prevention from and deceleration of the disability process is of the critical issues in psychiatric rehabilitation. Unfortunately, evidence- based effective programs are limited. Recently, a novel balance training program through cognitive and balance dual task training has shown better outcomes in the elderly and other clinical populations. Yet, the dual task balance training has not been examined for schizophrenia. This dual task balance training with the Internet of Thing techniques is a novel and important program for middle-aged and older individuals with schizophrenia. Further study is needed to develop the training program and to examine the effectiveness.
Purposes: (1) To develop a cognitive and balance dual task training program involving the Internet of Thing technique software - Cognitive and Balance training Simultaneously software (CogBals software) (1st year); (2) to pilot the feasibility of the balance training program for the middle-aged and older individuals with schizophrenia and revise it (1st year); and (3) to examine the effects of the balance training program on balance, cognitive functions, and the muscular endurance of lower extremities (2nd to 3rd year).
Methods: For the effectiveness analysis phase, a 3-arm, single-blinded, randomized controlled trial is used to recruit 84 participants and then randomly allocated to the cognitive and balance dual task training group (COG\&BAL), the balance training group (BAL), and the treatment as usual group. The first two training groups (COG\&BAL, BAL) receive training for 60 minutes in a group format, 2 times weekly, for 12 weeks. All participants will be assessed at baseline and posttest. The primary outcome is balance function and secondary outcomes are cognitive functions and the muscular endurance of lower extremities.
Contribution: The study uses cognitive and balance dual task training and expect better outcomes on balance improvement. The program can serve as an evidence- based program to prevent and to decelerate the disability process from people with mental illness. The CogBals software developed by researchers and training in a group format is good to promote in the clinical setting with less manpower.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- the cognitive and balance dual task training group (COG\&BAL), the balance training group (BAL), and the treatment as usual group
| Arm | Type | Receives |
|---|---|---|
| the cognitive and balance dual task training group | Experimental | Behavioral: cognitive and balance dual task trainingIt is performed using the CogBals software, emphasizing the completion of cognitive tasks while performing balance/strength training during the training process. |
| the balance training group | Experimental | Behavioral: balance trainingBalance/strength training without cognitive challenges. |
| the treatment as usual group | No intervention | –Maintain usual rehabilitation activities. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- diagnosis of schizophrenia or schizoaffective disorder for more than 1 year by psychiatrist according to Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5)
- age 40-75 years old
- have stable psychiatric symptoms currently (main psychotropic medications have not been adjusted for two months
- being able to ambulate independently for more than 10 meters, without a walking device
- not have significant cognitive impairment (Montreal Cognitive Assessment Taiwan Version, MoCA≧20)
Key exclusion criteria (7 listed)
- currently in the psychiatric acute award
- currently alcohol or drug use disorder
- Pregnancy, head trauma and other neuromusculoskeletal injuries affect training safety and compliance
- intellectual disability
- Unconsciousness or confusion
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 |
|---|---|---|
| cognitive and balance dual task trainingAlso: Use Cognitive and Balance training Simultaneously software (CogBals)a cognitive and balance dual task training program involving the Internet of Thing technique software - Cognitive and Balance training Simultaneously software | Behavioural | the cognitive and balance dual task training group |
| balance trainingIncludes static balance, dynamic balance and strength training | Behavioural | the balance training group |
Primary outcome
Mini-Balance Evaluation System Test
Time frame: Change from baseline at 12 weeks
score from 0-28; higher score is better
Timed up and go test under single and dual tasks
Time frame: Change from baseline at 12 weeks
dual tasks include carrying a cup of water and calculation
Single leg stance test under single and dual tasks
Time frame: Change from baseline at 12 weeks
dual tasks include carrying a cup of water and calculation
Chinese version of Activities-specific Balance Confidence Scale
Time frame: Change from baseline at 12 weeks
score from 0-100; higher score is better
6 meter walk test
Time frame: Change from baseline at 12 weeks
7 secondary outcomes
Symbol Coding
Time frame: Change from baseline at 12 weeks
Digit Span
Time frame: Change from baseline at 12 weeks
Spatial Span
Time frame: Change from baseline at 12 weeks
The Stroop Color and Word Test
Time frame: Change from baseline at 12 weeks
Color Trials Test
Time frame: Change from baseline at 12 weeks
30-second sit to stand test
Time frame: Change from baseline at 12 weeks
Bilateral standing heel-rise test
Time frame: Change from baseline at 12 weeks
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 21 Jun 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cognitive and balance dual task training and balance training in people with Schizophrenia and Cognition, run by Kaohsiung Medical University Chung-Ho 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 6 inclusion and 7 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 21 Jun 2024. 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?
Mini-Balance Evaluation System Test (time frame: Change from baseline at 12 weeks). The study lists 5 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 21 Jun 2024.