Cognitive and Balance Dual Task Training for People With Schizophrenia

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05341804
• Other study ID #: KMUHIRB-F(I)-20210071
• Status: Recruiting
• Phase: N/A
• Start date: May 10, 2022
• Est. completion date: July 31, 2024

Study information

• Verified date: March 2022
• Source: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Contact: Ming-De Chen, Professor
• Phone: +886-988202035
• Email: mdchen[@]kmu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 81 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.

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 81 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 81
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Balance
• Cognition
• Dual Task
• Fall Prevention
• Mental Disorders
• Mental Illness
• Problem Behavior
• Psychiatric Disorder
• Schizophrenia

Intervention

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
• balance training
Includes static balance, dynamic balance and strength training

Locations

Country	Name	City	State
Taiwan	Kaohsiung Medical University	Kaohsiung

Sponsors (3)

Lead Sponsor	Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung Medical University, Ministry of Science and Technology, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mini-Balance Evaluation System Test	score from 0-28; higher score is better	Change from baseline at 12 weeks
Primary	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
Primary	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
Primary	Chinese version of Activities-specific Balance Confidence Scale	score from 0-100; higher score is better	Change from baseline at 12 weeks
Primary	6 meter walk test		Change from baseline at 12 weeks
Secondary	Symbol Coding	The participant writes as many answers as possible within 90 seconds.	Change from baseline at 12 weeks
Secondary	Digit Span	score from 0-33; higher score is better	Change from baseline at 12 weeks
Secondary	Spatial Span	score from 0-32; higher score is better	Change from baseline at 12 weeks
Secondary	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
Secondary	Color Trials Test	Color Trials 1 and Color Trials 2	Change from baseline at 12 weeks
Secondary	30-second sit to stand test	The participant completes as many full stands as possible within 30 seconds.	Change from baseline at 12 weeks
Secondary	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