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临床试验/NCT05341804
NCT05341804已完成不适用

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

Kaohsiung Medical University Chung-Ho Memorial Hospital2 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2022年5月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
84
试验地点
2
主要终点
Timed up and go test under single and dual tasks

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

blinded assessor

入排标准

年龄范围
40 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Timed up and go test under single and dual tasks

时间窗: Change from baseline at 12 weeks

dual tasks include carrying a cup of water and calculation

Chinese version of Activities-specific Balance Confidence Scale

时间窗: Change from baseline at 12 weeks

score from 0-100; higher score is better

6 meter walk test

时间窗: Change from baseline at 12 weeks

Mini-Balance Evaluation System Test

时间窗: Change from baseline at 12 weeks

score from 0-28; higher score is better

Single leg stance test under single and dual tasks

时间窗: Change from baseline at 12 weeks

dual tasks include carrying a cup of water and calculation

次要结局

  • Symbol Coding(Change from baseline at 12 weeks)
  • Digit Span(Change from baseline at 12 weeks)
  • Spatial Span(Change from baseline at 12 weeks)
  • The Stroop Color and Word Test(Change from baseline at 12 weeks)
  • Color Trials Test(Change from baseline at 12 weeks)
  • 30-second sit to stand test(Change from baseline at 12 weeks)
  • Bilateral standing heel-rise test(Change from baseline at 12 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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