Clinical trial NCT05341804: 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
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Cognition
Balance
Dual Task
Mental Illness
Psychiatric Disorder
Fall Prevention
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
Collaborators: name: Kaohsiung Medical University
name: Ministry of Science and Technology, Taiwan
First posted: 2022-04-22
Enrollment: 84
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: the cognitive and balance dual task training group (COG\&BAL), the balance training group (BAL), and the treatment as usual group
Primary purpose: TREATMENT

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 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.

Eligibility criteria: Inclusion Criteria:

1. 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)
2. age 40-75 years old
3. have stable psychiatric symptoms currently (main psychotropic medications have not been adjusted for two months
4. being able to ambulate independently for more than 10 meters, without a walking device
5. not have significant cognitive impairment (Montreal Cognitive Assessment Taiwan Version, MoCA≧20)
6. can follow study protocol and sign the informed consent form

Exclusion Criteria:

1. currently in the psychiatric acute award
2. currently alcohol or drug use disorder
3. Pregnancy, head trauma and other neuromusculoskeletal injuries affect training safety and compliance
4. intellectual disability
5. Unconsciousness or confusion
6. 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
7. Currently participating in other interventional study

Primary outcomes:
measure: Mini-Balance Evaluation System Test
timeFrame: Change from baseline at 12 weeks
measure: Timed up and go test under single and dual tasks
timeFrame: Change from baseline at 12 weeks
measure: Single leg stance test under single and dual tasks
timeFrame: Change from baseline at 12 weeks
measure: Chinese version of Activities-specific Balance Confidence Scale
timeFrame: Change from baseline at 12 weeks
measure: 6 meter walk test
timeFrame: Change from baseline at 12 weeks
Secondary outcomes:
measure: Symbol Coding
timeFrame: Change from baseline at 12 weeks
measure: Digit Span
timeFrame: Change from baseline at 12 weeks
measure: Spatial Span
timeFrame: Change from baseline at 12 weeks
measure: The Stroop Color and Word Test
timeFrame: Change from baseline at 12 weeks
measure: Color Trials Test
timeFrame: Change from baseline at 12 weeks
measure: 30-second sit to stand test
timeFrame: Change from baseline at 12 weeks
measure: Bilateral standing heel-rise test
timeFrame: Change from baseline at 12 weeks
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University
Study officials:
References: