Cognitive and Balance Dual Task Training for People With Schizophrenia

NCT ID: NCT05341804

Last Updated: 2024-06-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-10
• Study Completion Date: 2023-09-15

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

the cognitive and balance dual task training group

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

Group Type: EXPERIMENTAL

cognitive and balance dual task training

Intervention Type: BEHAVIORAL

a cognitive and balance dual task training program involving the Internet of Thing technique software - Cognitive and Balance training Simultaneously software

the balance training group

Balance/strength training without cognitive challenges.

Group Type: EXPERIMENTAL

balance training

Intervention Type: BEHAVIORAL

Includes static balance, dynamic balance and strength training

the treatment as usual group

Maintain usual rehabilitation activities.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

cognitive and balance dual task training

a cognitive and balance dual task training program involving the Internet of Thing technique software - Cognitive and Balance training Simultaneously software

Intervention Type: BEHAVIORAL

balance training

Includes static balance, dynamic balance and strength training

Intervention Type: BEHAVIORAL

Other Intervention Names

Use Cognitive and Balance training Simultaneously software (CogBals)

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kaohsiung Medical University

OTHER

Sponsor Role: collaborator

Ministry of Science and Technology, Taiwan

OTHER_GOV

Sponsor Role: collaborator

Kaohsiung Medical University Chung-Ho Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Kaohsiung Medical University

Kaohsiung City, , Taiwan

Countries

Taiwan

Other Identifiers

KMUHIRB-F(I)-20210071

Identifier Type: -

Identifier Source: org_study_id