Cognitive and Balance Dual Task Training for People With Schizophrenia

Cognitive and Balance Dual Task Training for People With Schizophrenia - Program System Development and Effectiveness Analysis

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia; Mental Illness; Psychiatric Disorder; Cognition; Balance; Dual Task; Fall Prevention
• Intervention / Treatment: Behavioral: cognitive and balance dual task training; Behavioral: balance training

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 Type: Interventional
• Enrollment (Actual): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Kaohsiung, Taiwan, 807
    • Kaohsiung Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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; Other Names: Use Cognitive and Balance training Simultaneously software (CogBals)
Experimental: the balance training group; Balance/strength training without cognitive challenges.	Behavioral: balance training; Includes static balance, dynamic balance and strength training
No Intervention: the treatment as usual group; Maintain usual rehabilitation activities.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symbol Coding	The participant writes as many answers as possible within 90 seconds.	Change from baseline at 12 weeks
Digit Span	score from 0-33; higher score is better	Change from baseline at 12 weeks
Spatial Span	score from 0-32; higher score is better	Change from baseline at 12 weeks
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.	Change from baseline at 12 weeks
Color Trials Test	Color Trials 1 and Color Trials 2	Change from baseline at 12 weeks
30-second sit to stand test	The participant completes as many full stands as possible within 30 seconds.	Change from baseline at 12 weeks
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.	Change from baseline at 12 weeks

Collaborators and Investigators

• Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Collaborators: Kaohsiung Medical University; Ministry of Science and Technology, Taiwan

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2022
• Primary Completion (Actual): September 15, 2023
• Study Completion (Actual): September 15, 2023

Study Registration Dates

• First Submitted: April 5, 2022
• First Submitted That Met QC Criteria: April 17, 2022
• First Posted (Actual): April 22, 2022

Study Record Updates

• Last Update Posted (Actual): June 21, 2024
• Last Update Submitted That Met QC Criteria: June 19, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Problem Behavior; Mental Disorders
• Other Study ID Numbers: KMUHIRB-F(I)-20210071

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No