Cognitive and Balance Dual Task Training for People With Schizophrenia
Primary Purpose
Schizophrenia, Cognition, Balance
Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
cognitive and balance dual task training
balance training
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Kaohsiung Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
the cognitive and balance dual task training group
the balance training group
the treatment as usual group
Arm Description
It is performed using the CogBals software, emphasizing the completion of cognitive tasks while performing balance/strength training during the training process.
Balance/strength training without cognitive challenges.
Maintain usual rehabilitation activities.
Outcomes
Primary Outcome Measures
Mini-Balance Evaluation System Test
score from 0-28; higher score is better
Timed up and go test under single and dual tasks
dual tasks include carrying a cup of water and calculation
Single leg stance test under single and dual tasks
dual tasks include carrying a cup of water and calculation
Chinese version of Activities-specific Balance Confidence Scale
score from 0-100; higher score is better
6 meter walk test
Secondary Outcome Measures
Symbol Coding
The participant writes as many answers as possible within 90 seconds.
Digit Span
score from 0-33; higher score is better
Spatial Span
score from 0-32; higher score is better
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.
Color Trials Test
Color Trials 1 and Color Trials 2
30-second sit to stand test
The participant completes as many full stands as possible within 30 seconds.
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.
Full Information
NCT ID
NCT05341804
First Posted
April 5, 2022
Last Updated
August 22, 2022
Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
Collaborators
Kaohsiung Medical University, Ministry of Science and Technology, Taiwan
1. Study Identification
Unique Protocol Identification Number
NCT05341804
Brief Title
Cognitive and Balance Dual Task Training for People With Schizophrenia
Official Title
Cognitive and Balance Dual Task Training for People With Schizophrenia - Program System Development and Effectiveness Analysis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 10, 2022 (Actual)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
Collaborators
Kaohsiung Medical University, Ministry of Science and Technology, Taiwan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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 81 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 81 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Cognition, Balance, Dual Task, Mental Illness, Psychiatric Disorder, Fall Prevention
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
the cognitive and balance dual task training group (COG&BAL), the balance training group (BAL), and the treatment as usual group
Masking
Outcomes Assessor
Masking Description
blinded assessor
Allocation
Randomized
Enrollment
81 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
the cognitive and balance dual task training group
Arm Type
Experimental
Arm Description
It is performed using the CogBals software, emphasizing the completion of cognitive tasks while performing balance/strength training during the training process.
Arm Title
the balance training group
Arm Type
Experimental
Arm Description
Balance/strength training without cognitive challenges.
Arm Title
the treatment as usual group
Arm Type
No Intervention
Arm Description
Maintain usual rehabilitation activities.
Intervention Type
Behavioral
Intervention Name(s)
cognitive and balance dual task training
Other Intervention Name(s)
Use Cognitive and Balance training Simultaneously software (CogBals)
Intervention Description
a cognitive and balance dual task training program involving the Internet of Thing technique software - Cognitive and Balance training Simultaneously software
Intervention Type
Behavioral
Intervention Name(s)
balance training
Intervention Description
Includes static balance, dynamic balance and strength training
Primary Outcome Measure Information:
Title
Mini-Balance Evaluation System Test
Description
score from 0-28; higher score is better
Time Frame
Change from baseline at 12 weeks
Title
Timed up and go test under single and dual tasks
Description
dual tasks include carrying a cup of water and calculation
Time Frame
Change from baseline at 12 weeks
Title
Single leg stance test under single and dual tasks
Description
dual tasks include carrying a cup of water and calculation
Time Frame
Change from baseline at 12 weeks
Title
Chinese version of Activities-specific Balance Confidence Scale
Description
score from 0-100; higher score is better
Time Frame
Change from baseline at 12 weeks
Title
6 meter walk test
Time Frame
Change from baseline at 12 weeks
Secondary Outcome Measure Information:
Title
Symbol Coding
Description
The participant writes as many answers as possible within 90 seconds.
Time Frame
Change from baseline at 12 weeks
Title
Digit Span
Description
score from 0-33; higher score is better
Time Frame
Change from baseline at 12 weeks
Title
Spatial Span
Description
score from 0-32; higher score is better
Time Frame
Change from baseline at 12 weeks
Title
The Stroop Color and Word Test
Description
The participant reads color words or names ink colors from different pages as quickly as possible within 45 seconds.
Time Frame
Change from baseline at 12 weeks
Title
Color Trials Test
Description
Color Trials 1 and Color Trials 2
Time Frame
Change from baseline at 12 weeks
Title
30-second sit to stand test
Description
The participant completes as many full stands as possible within 30 seconds.
Time Frame
Change from baseline at 12 weeks
Title
Bilateral standing heel-rise test
Description
The participant performs the maximum number of plantar flexions possible, until the point of voluntary fatigue, as fast as possible.
Time Frame
Change from baseline at 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ming-De Chen, Professor
Phone
+886-988202035
Email
mdchen@kmu.edu.tw
Facility Information:
Facility Name
Kaohsiung Medical University
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ming-De Chen, Professor
Phone
+886-988202035
Email
mchen37@gmail.com
12. IPD Sharing Statement
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Cognitive and Balance Dual Task Training for People With Schizophrenia
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