Cognitive and Balance Dual Task Training for People With Schizophrenia

Kaohsiung Medical University

Status: Completed

Conditions: Balance; Psychiatric Disorder; Mental Illness; Schizophrenia; Cognition; Fall Prevention; Dual Task

Treatments: Behavioral: cognitive and balance dual task training; Behavioral: balance training

Study type: Interventional

Funder types: Other

Identifiers

NCT05341804

KMUHIRB-F(I)-20210071

Details and patient eligibility

About

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.

Full 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.

Enrollment: 84 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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84 participants in 3 patient groups

the cognitive and balance dual task training group

Experimental group

Description:

It is performed using the CogBals software, emphasizing the completion of cognitive tasks while performing balance/strength training during the training process.

Treatment:

Behavioral: cognitive and balance dual task training

the balance training group

Experimental group

Description:

Balance/strength training without cognitive challenges.

Treatment:

Behavioral: balance training

the treatment as usual group

No Intervention group

Description:

Maintain usual rehabilitation activities.