SchizophreniaNCT04143308
The Effects of Simultaneous Training of Walking and Cognitive Tasks on Cognitive Functions of People With Schizophrenia
A study testing Simultaneous training of walking and cognitive group, Cognitive training group and Treatment as usual group in people with Schizophrenia and Cognitive Function, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial summary
The object is to develop a training system of simultaneous walking and cognitive training for improving cognitive function of people with schizophrenia. The training program, called "Simultaneous Walk And Think for Cognitive Health mobile application software"(SWATCH App), is developed by researchers. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Schizophrenia, Cognitive Function, Physical Activity
- What is being tested?
- Simultaneous training of walking and cognitive group, Cognitive training group and Treatment as usual group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTaiwan
- Study dates
- 5 Nov 2019to 7 Jul 2021
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of schizophrenia or schizoaffective disorder by a psychiatric clinician on the basis of the criteria set the Diagnostic and Statistical Manual of Mental Disorders 5th edition, DSM-5, has been more than 1 year.
- Age 20-60 years old.
- Living in daycare center or community-based mental health rehabilitation services or rehabilitation ward.
- Having stable psychiatric conditions (i.e., primary psychiatric medications had not changed for more than two months)
- The MATRICS Consensus Cognitive Battery (MCCB) (Nuechterlein et al., 2008) shows that at least one domain with cognitive impairment (below the value of -1SD).
- Can follow the research process and sign the consent form.
Who cannot join
- Traumatic brain injury and other neurological diseases, alcohol and substance abuse
- Pregnancy, cardiovascular disease, and unsuitable to exercise training due to physical movement difficulties
- According participants' self-report, having following conditions, including severe heart failure, myocardial infarction, angina pectoris, chronic obstructive pulmonary disease, COPD, poor glycemic control (i.e., dialysis, diabetic neuropathy or retinopathy) and lower extremity arthritis
- Uncontrolled hypertension with SBP> 160 mmHg or DBP> 110 mmHg
- Diagnosis of intellectual disability
- Unconscious or confusion of consciousness
- Participating in other intervention studies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Simultaneous Training of Walking and Cognitive Tasks on Cognitive Functions of People With Schizophrenia: the Development of Mobile Application System and Effectiveness Analysis
The object is to develop a training system of simultaneous walking and cognitive training for improving cognitive function of people with schizophrenia. The training program, called "Simultaneous Walk And Think for Cognitive Health mobile application software"(SWATCH App), is developed by researchers. A randomized controlled trial will be carried out to test the effectiveness of the training system. Ninety participants will be randomly assigned to: simultaneous training of walking and cognitive group, the cognitive training group, and treatment as usual group. The intervention for those groups will lasts for 12 weeks, with a 12 week of followup. The measurements include the cognitive function, physical fitness, and quality of life.
Read the detailed description
Background: Schizophrenia is one of the severe mental disorders. In addition to psychiatric symptoms, cognitive impairment is a key clinical feature in this population, which significantly negatively influences their functional performance and independence. While the cognitive remediation therapy demonstrates positive results, it often involves specialized and expensive computerized cognitive training system, which limits its application in clinical setting. More evidence is available to support the benefits of exercise training on cognitive functions of schizophrenia. Combination of exercise and cognitive training is a promising program and can improve cognitive functions of the elderly. However, this combined therapy is still limited to schizophrenia. Simultaneous training of walking and cognitive tasks via auditory mobile application is an innovative program for saving cost, time, and manpower. Further study is needed to develop the simultaneous training program and to examine the effectiveness.
Purposes: To examine the effects of the training program on cognitive functions, fitness, functional performance and quality of life.
Methods: A 3-arm, single-blinded, randomized controlled trial is used to recruit 90 participants and then randomly allocated to the simultaneous training group, the cognitive training group, and the treatment as usual group. The first two training groups receive training for 30-40 minutes, 3 times a week for 12 weeks, as well as a follow-up of 12 weeks. All participants will be assessed at baseline, post-test and follow-up assessment. Primary outcome is cognitive function and secondary outcomes are fitness, functional performance, and quality of life.
Contribution: The study can be used as an evidence-based program to improve cognitive functioning of people with schizophrenia. With the development of mobile App and the use of fitness wearable device, the training program enables people with schizophrenia to walk and practice cognitive training simultaneously in a group format. It will help clinical professionals be able to serve the increasing number of people with severe mental illness with less manpower and specialized equipment. The study is also helpful to better understanding the isolated role of aerobic exercise in the dual-task training, and to apply to other groups, like the elderly or dementia.
- Conditions
- Schizophrenia, Cognitive Function, Physical Activity, Quality of Life
- Being tested
- Simultaneous training of walking and cognitive group, Cognitive training group, Treatment as usual group
- Keywords
- Schizophrenia, Cognitive functional training, Dual-task training, Aerobic exercise, Mobile application
- Medical subject headings
- Schizophrenia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simultaneous training of walking and cognitive groupOther
Device:
- SWATCH system (App \& controller)
- Wearable technology Fitness wristband \& APP
Cognitive training groupOther
Device:
- SWATCH system (App)
- Wearable technology Fitness wristband \& APP
Treatment as usual groupOther
Keep treatment as usual
| Study group | Role | What they receive |
|---|---|---|
| Simultaneous training of walking and cognitive group | Experimental | 1. Wearable technology (fitness wristband \& App)
2. SWATCH system (App \& controller)
3. 3 times a week (30 mins/ each time)
4. Lasts for 12 weeks
5. Simultaneous walking and cognitive training Receives: Other: Simultaneous training of walking and cognitive group |
| Cognitive training group | Active comparator | 1. Wearable technology (fitness wristband \& App)
2. SWATCH system (App)
3. 3 times a week (30 mins/ each time)
4. Lasts for 12 weeks
5. Cognitive training while sitting Receives: Other: Cognitive training group |
| Treatment as usual group | Active comparator | 1. Keep treatment as usual group at health care system. Receives: Other: Treatment as usual group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive function
MATRICS Consensus Cognitive Battery: Traditional Chinese Version (MCCB) consists of 10 individually administered tests to measure cognitive performance in the following seven domains:
- Processing Speed 1.1 Trail Making Test (TMT). 1.2 Brief Assessment of Cognition in Schizophrenia: Symbol Coding (BACS SC). 1.3 Category Fluency: Animal Naming (Fluency).
- Attention 2.1 Continuous Performance Test: Identical Pairs (CPT-IP).
- Working memory 3.1 Wechsler Memory Scale-III (WMS III): Spatial Span. 3.2 Wechsler Letter: Number Sequencing (WAIS-III).
- Verbal Learning 4.1 Hopkins Verbal Learning Test-Revised (HVLT-R).
- Visual Learning 5.1 Brief Visuospatial Memory Test-Revised (BVMT-R).
- Reasoning and Problem Solving 6.1 Neuropsychological Assessment Battery (NAB): Mazes.
- Social Cognition
7.1 Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT): Managing Emotions.
Measured: Change from baseline outcome measure at 12th week (post-test), and at 24th week (follow-up test)
Secondary outcomes (7)
Body composition
Using Body Mass Index (BMI) as the measurement of body composition, which weight and height will be combined to report BMI in kg/m^2.
Measured: Change from baseline outcome measure at 12th week (post-test), and at 24th week (follow-up test)
Cardiorespiratory fitness
Using 6-minute walk test (6MWT) as the measurement, which let the participant walks as far as possible over a total of six minutes on hard and flat floor. And the researcher will measure the distance that participant walks in 6 minutes.
Measured: Change from baseline outcome measure at 12th week (post-test), and at 24th week (follow-up test)
Leg muscular strength and endurance
Using 30-Second Sit to Stand Test. The participant will sit in the middle of the chair, and rise to a full standing position, then sit back down again. Repeat these movements for 30 seconds. And researcher will count the times.
Measured: Change from baseline outcome measure at 12th week (post-test), and at 24th week (follow-up test)
Balance and Agility
The Timed Up and Go test (TUG). It measures the time that the participant takes to rise from a chair, walk eight foots, turn around, walk back to the chair, and sit down.
Measured: Change from baseline outcome measure at 12th week (post-test), and at 24th week (follow-up test)
Dual-Task Performance Involving Hand Dexterity and Cognitive Tasks
Dual-Task Performance Involving Hand Dexterity and Cognitive Tasks, this test is combine the Purdue Pegboard Test (PPT; Tiffin \& Asher, 1948) and the Serial Sevens Subtraction Test (SSST; Manning, 1982), Purdue Pegboard Test use to measures hand dexterity; Serial Sevens Subtraction Test as a cognitive task for the dual-task condition.
Measured: Change from baseline outcome measure at 12th week (post-test), and at 24th week (follow-up test)
Instrumental Activity of Daily Living (IADL)
Lawton and Brody Instrumental Activity of Daily Living Scale is a self-report survey. It is used to evaluate the degree of participant's instrumental activities. There are total 8 descriptions, the scale scores ranges is between 0 to 8. The higher values represent a better outcome.
Measured: Change from baseline outcome measure at 12th week (post-test), and at 24th week (follow-up test)
Schizophrenia Quality of Life Scale Revision 4 (SQLS-R4)
Schizophrenia Quality of Life Scale Revision 4 is a self-report survey. It is used to evaluate the degree of participant's quality of life. There are total 33 items, the scale scores statements are rated 1 (never) to 5 (always). The higher values represent a better outcome.
Measured: Change from baseline outcome measure at 12th week (post-test), and at 24th week (follow-up test)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2019
- Study start5 Nov 2019
- Primary completion7 Jul 2021
- Study completion7 Jul 2021
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- We will conduct a single-blinded, randomized controlled study. Ninety participants will be randomly assigned to: simultaneous training of walking and cognitive group, the cognitive training group, and treatment as usual group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ming-De Chen, Ph.D., Principal investigator, Department of Occupational Therapy, College of Health Sciences, Kaohsiung Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04143308
- Sponsor's protocol ID
- KMUHIRB-SV(I)-20170080
- Status last verified
- Sep 2021
- First submitted
- 18 Oct 2019
- Last updated
- 21 Jun 2024
- 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 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Simultaneous Training of Walking and Cognitive Tasks on Cognitive Functions of People With Schizophrenia: the Development of Mobile Application System and Effectiveness Analysis
- ClinicalTrials.gov ID
- NCT04143308
- Acronym / sponsor ID
- KMUHIRB-SV(I)-20170080
- Conditions
- Schizophrenia, Cognitive Function, Physical Activity, Quality of Life
- Keywords
- Schizophrenia, Cognitive functional training, Dual-task training, Aerobic exercise, Mobile application
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- 5 Nov 2019 (actual)
- Primary completion
- 7 Jul 2021 (actual)
- Study completion
- 7 Jul 2021 (actual)
- First posted
- 29 Oct 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 object is to develop a training system of simultaneous walking and cognitive training for improving cognitive function of people with schizophrenia. The training program, called "Simultaneous Walk And Think for Cognitive Health mobile application software"(SWATCH App), is developed by researchers. A randomized controlled trial will be carried out to test the effectiveness of the training system. Ninety participants will be randomly assigned to: simultaneous training of walking and cognitive group, the cognitive training group, and treatment as usual group. The intervention for those groups will lasts for 12 weeks, with a 12 week of followup. The measurements include the cognitive function, physical fitness, and quality of life.
Detailed description
Background: Schizophrenia is one of the severe mental disorders. In addition to psychiatric symptoms, cognitive impairment is a key clinical feature in this population, which significantly negatively influences their functional performance and independence. While the cognitive remediation therapy demonstrates positive results, it often involves specialized and expensive computerized cognitive training system, which limits its application in clinical setting. More evidence is available to support the benefits of exercise training on cognitive functions of schizophrenia. Combination of exercise and cognitive training is a promising program and can improve cognitive functions of the elderly. However, this combined therapy is still limited to schizophrenia. Simultaneous training of walking and cognitive tasks via auditory mobile application is an innovative program for saving cost, time, and manpower. Further study is needed to develop the simultaneous training program and to examine the effectiveness.
Purposes: To examine the effects of the training program on cognitive functions, fitness, functional performance and quality of life.
Methods: A 3-arm, single-blinded, randomized controlled trial is used to recruit 90 participants and then randomly allocated to the simultaneous training group, the cognitive training group, and the treatment as usual group. The first two training groups receive training for 30-40 minutes, 3 times a week for 12 weeks, as well as a follow-up of 12 weeks. All participants will be assessed at baseline, post-test and follow-up assessment. Primary outcome is cognitive function and secondary outcomes are fitness, functional performance, and quality of life.
Contribution: The study can be used as an evidence-based program to improve cognitive functioning of people with schizophrenia. With the development of mobile App and the use of fitness wearable device, the training program enables people with schizophrenia to walk and practice cognitive training simultaneously in a group format. It will help clinical professionals be able to serve the increasing number of people with severe mental illness with less manpower and specialized equipment. The study is also helpful to better understanding the isolated role of aerobic exercise in the dual-task training, and to apply to other groups, like the elderly or dementia.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- We will conduct a single-blinded, randomized controlled study. Ninety participants will be randomly assigned to: simultaneous training of walking and cognitive group, the cognitive training group, and treatment as usual group.
| Arm | Type | Receives |
|---|---|---|
| Simultaneous training of walking and cognitive group | Experimental | Other: Simultaneous training of walking and cognitive group1. Wearable technology (fitness wristband \& App) 2. SWATCH system (App \& controller) 3. 3 times a week (30 mins/ each time) 4. Lasts for 12 weeks 5. Simultaneous walking and cognitive training |
| Cognitive training group | Active comparator | Other: Cognitive training group1. Wearable technology (fitness wristband \& App) 2. SWATCH system (App) 3. 3 times a week (30 mins/ each time) 4. Lasts for 12 weeks 5. Cognitive training while sitting |
| Treatment as usual group | Active comparator | Other: Treatment as usual group1. Keep treatment as usual group at health care system. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Diagnosis of schizophrenia or schizoaffective disorder by a psychiatric clinician on the basis of the criteria set the Diagnostic and Statistical Manual of Mental Disorders 5th edition, DSM-5, has been more than 1 year.
- Age 20-60 years old.
- Living in daycare center or community-based mental health rehabilitation services or rehabilitation ward.
- Having stable psychiatric conditions (i.e., primary psychiatric medications had not changed for more than two months)
- The MATRICS Consensus Cognitive Battery (MCCB) (Nuechterlein et al., 2008) shows that at least one domain with cognitive impairment (below the value of -1SD).
Key exclusion criteria (7 listed)
- Traumatic brain injury and other neurological diseases, alcohol and substance abuse
- Pregnancy, cardiovascular disease, and unsuitable to exercise training due to physical movement difficulties
- According participants' self-report, having following conditions, including severe heart failure, myocardial infarction, angina pectoris, chronic obstructive pulmonary disease, COPD, poor glycemic control (i.e., dialysis, diabetic neuropathy or retinopathy) and lower extremity arthritis
- Uncontrolled hypertension with SBP> 160 mmHg or DBP> 110 mmHg
- Diagnosis of intellectual disability
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 |
|---|---|---|
| Simultaneous training of walking and cognitive groupDevice: 1. SWATCH system (App \& controller) 2. Wearable technology Fitness wristband \& APP | Other | Simultaneous training of walking and cognitive group |
| Cognitive training groupDevice: 1. SWATCH system (App) 2. Wearable technology Fitness wristband \& APP | Other | Cognitive training group |
| Treatment as usual groupKeep treatment as usual | Other | Treatment as usual group |
Primary outcome
Cognitive function
Time frame: Change from baseline outcome measure at 12th week (post-test), and at 24th week (follow-up test)
MATRICS Consensus Cognitive Battery: Traditional Chinese Version (MCCB) consists of 10 individually administered tests to measure cognitive performance in the following seven domains: 1. Processing Speed 1.1 Trail Making Test (TMT). 1.2 Brief Assessment of Cognition in Schizophrenia: Symbol Coding (BACS SC). 1.3 Category Fluency: Animal Naming (Fluency). 2. Attention 2.1 Continuous Performance Test: Identical Pairs (CPT-IP). 3. Working memory 3.1 Wechsler Memory Scale-III (WMS III): Spatial Span. 3.2 Wechsler Letter: Number Sequencing (WAIS-III). 4. Verbal Learning 4.1 Hopkins Verbal Learning Test-Revised (HVLT-R). 5. Visual Learning 5.1 Brief Visuospatial Memory Test-Revised (BVMT-R). 6. Reasoning and Problem Solving 6.1 Neuropsychological Assessment Battery (NAB): Mazes. 7. Social Cognition 7.1 Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT): Managing Emotions.
7 secondary outcomes
Body composition
Time frame: Change from baseline outcome measure at 12th week (post-test), and at 24th week (follow-up test)
Cardiorespiratory fitness
Time frame: Change from baseline outcome measure at 12th week (post-test), and at 24th week (follow-up test)
Leg muscular strength and endurance
Time frame: Change from baseline outcome measure at 12th week (post-test), and at 24th week (follow-up test)
Balance and Agility
Time frame: Change from baseline outcome measure at 12th week (post-test), and at 24th week (follow-up test)
Dual-Task Performance Involving Hand Dexterity and Cognitive Tasks
Time frame: Change from baseline outcome measure at 12th week (post-test), and at 24th week (follow-up test)
Instrumental Activity of Daily Living (IADL)
Time frame: Change from baseline outcome measure at 12th week (post-test), and at 24th week (follow-up test)
Schizophrenia Quality of Life Scale Revision 4 (SQLS-R4)
Time frame: Change from baseline outcome measure at 12th week (post-test), and at 24th week (follow-up test)
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.
- 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.
Ming-De Chen, Ph.D. principal investigator
Department of Occupational Therapy, College of Health Sciences, Kaohsiung Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simultaneous training of walking and cognitive group, Cognitive training group and Treatment as usual group in people with Schizophrenia and Cognitive Function, 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?
Cognitive function (time frame: Change from baseline outcome measure at 12th week (post-test), and at 24th week (follow-up test)). 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.