Cognitive and Balance Dual Task Training for People With Schizophrenia

Not Applicable

Completed

• Conditions: Dual Task; Mental Illness; Fall Prevention; Schizophrenia; Cognition; Balance; Psychiatric Disorder
• Interventions: Behavioral: balance training; Behavioral: cognitive and balance dual task training

• Registration Number: NCT05341804
• Lead Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

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.

Study Timeline

• Study First Submitted: 2022-04-05
• Study First Submitted QC: 2022-04-17
• Study First Posted: 2022-04-22
• Study Start: 2022-05-10
• Primary Completion: 2023-09-15
• Study Completion: 2023-09-15
• Status Verified: 2024-04
• Last Update Submitted: 2024-06-19
• Last Update Posted: 2024-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
the balance training group	balance training	Balance/strength training without cognitive challenges.
the cognitive and balance dual task training group	cognitive and balance dual task training	It is performed using the CogBals software, emphasizing the completion of cognitive tasks while performing balance/strength training during the training process.

Primary Outcome Measures

Name	Time	Method
Timed up and go test under single and dual tasks	Change from baseline at 12 weeks	dual tasks include carrying a cup of water and calculation
Chinese version of Activities-specific Balance Confidence Scale	Change from baseline at 12 weeks	score from 0-100; higher score is better
6 meter walk test	Change from baseline at 12 weeks
Mini-Balance Evaluation System Test	Change from baseline at 12 weeks	score from 0-28; higher score is better
Single leg stance test under single and dual tasks	Change from baseline at 12 weeks	dual tasks include carrying a cup of water and calculation

Secondary Outcome Measures

Name	Time	Method
Symbol Coding	Change from baseline at 12 weeks	The participant writes as many answers as possible within 90 seconds.
Digit Span	Change from baseline at 12 weeks	score from 0-33; higher score is better
Spatial Span	Change from baseline at 12 weeks	score from 0-32; higher score is better
The Stroop Color and Word Test	Change from baseline at 12 weeks	The participant reads color words or names ink colors from different pages as quickly as possible within 45 seconds.
Color Trials Test	Change from baseline at 12 weeks	Color Trials 1 and Color Trials 2
30-second sit to stand test	Change from baseline at 12 weeks	The participant completes as many full stands as possible within 30 seconds.
Bilateral standing heel-rise test	Change from baseline at 12 weeks	The participant performs the maximum number of plantar flexions possible, until the point of voluntary fatigue, as fast as possible.

Trial Locations

Locations (1)

Kaohsiung Medical University; 🇨🇳 Kaohsiung, Taiwan