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Completed

NCT Number: NCT05341804

Cognitive and Balance Dual Task Training for People With Schizophrenia

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.

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Key information

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaohsiung Medical University

Kaohsiung City, 807, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)
  • age 40-75 years old
  • have stable psychiatric symptoms currently (main psychotropic medications have not been adjusted for two months
  • being able to ambulate independently for more than 10 meters, without a walking device
  • not have significant cognitive impairment (Montreal Cognitive Assessment Taiwan Version, MoCA≧20)
  • can follow study protocol and sign the informed consent form

Exclusion criteria

  • currently in the psychiatric acute award
  • currently alcohol or drug use disorder
  • Pregnancy, head trauma and other neuromusculoskeletal injuries affect training safety and compliance
  • intellectual disability
  • Unconsciousness or confusion
  • 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
  • Currently participating in other interventional study

Treatment and study plan

cognitive and balance dual task training

Behavioral

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)

Balance training

Behavioral

Includes static balance, dynamic balance and strength training

Primary outcomes

  1. Mini-Balance Evaluation System Test

    Time frame: Change from baseline at 12 weeks

    score from 0-28; higher score is better

  2. Timed up and go test under single and dual tasks

    Time frame: Change from baseline at 12 weeks

    dual tasks include carrying a cup of water and calculation

  3. Single leg stance test under single and dual tasks

    Time frame: Change from baseline at 12 weeks

    dual tasks include carrying a cup of water and calculation

  4. Chinese version of Activities-specific Balance Confidence Scale

    Time frame: Change from baseline at 12 weeks

    score from 0-100; higher score is better

  5. 6 meter walk test

    Time frame: Change from baseline at 12 weeks

Secondary outcomes

  1. Symbol Coding

    Time frame: Change from baseline at 12 weeks

    The participant writes as many answers as possible within 90 seconds.

  2. Digit Span

    Time frame: Change from baseline at 12 weeks

    score from 0-33; higher score is better

  3. Spatial Span

    Time frame: Change from baseline at 12 weeks

    score from 0-32; higher score is better

  4. The Stroop Color and Word Test

    Time frame: 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.

  5. Color Trials Test

    Time frame: Change from baseline at 12 weeks

    Color Trials 1 and Color Trials 2

  6. 30-second sit to stand test

    Time frame: Change from baseline at 12 weeks

    The participant completes as many full stands as possible within 30 seconds.

  7. Bilateral standing heel-rise test

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Other

Collaborators

  • Kaohsiung Medical University
  • Ministry of Science and Technology, Taiwan

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 22, 2022
Registry last updated
Jun 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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