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The Effects of Simultaneous Training of Walking and Cognitive Tasks on Cognitive Functions of People With Schizophrenia

Primary Purpose

Schizophrenia, Cognitive Function, Physical Activity

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Simultaneous training of walking and cognitive group
Cognitive training group
Treatment as usual group
Sponsored by
Kaohsiung Medical University Chung-Ho Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Schizophrenia focused on measuring Schizophrenia, Cognitive functional training, Dual-task training, Aerobic exercise, Mobile application

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Diagnosis of schizophrenia or schizoaffective disorder by a psychiatric clinician on the basis of the criteria set the Diagnostic and Statistical Manual of Mental Disorders 5th edition, DSM-5, has been more than 1 year.
  2. Age 20-60 years old.
  3. Living in daycare center or community-based mental health rehabilitation services or rehabilitation ward.
  4. Having stable psychiatric conditions (i.e., primary psychiatric medications had not changed for more than two months)
  5. The MATRICS Consensus Cognitive Battery (MCCB) (Nuechterlein et al., 2008) shows that at least one domain with cognitive impairment (below the value of -1SD).
  6. Can follow the research process and sign the consent form.

Exclusion Criteria:

  1. Traumatic brain injury and other neurological diseases, alcohol and substance abuse
  2. Pregnancy, cardiovascular disease, and unsuitable to exercise training due to physical movement difficulties
  3. According participants' self-report, having following conditions, including severe heart failure, myocardial infarction, angina pectoris, chronic obstructive pulmonary disease, COPD, poor glycemic control (i.e., dialysis, diabetic neuropathy or retinopathy) and lower extremity arthritis
  4. Uncontrolled hypertension with SBP> 160 mmHg or DBP> 110 mmHg
  5. Diagnosis of intellectual disability
  6. Unconscious or confusion of consciousness
  7. Participating in other intervention studies

Sites / Locations

  • Ming-De ChenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Simultaneous training of walking and cognitive group

Cognitive training group

Treatment as usual group

Arm Description

Wearable technology (fitness wristband & App) SWATCH system (App & controller) 3 times a week (30 mins/ each time) Lasts for 12 weeks Simultaneous walking and cognitive training

Wearable technology (fitness wristband & App) SWATCH system (App) 3 times a week (30 mins/ each time) Lasts for 12 weeks Cognitive training while sitting

1. Keep treatment as usual group at health care system.

Outcomes

Primary Outcome Measures

Cognitive function
MATRICS Consensus Cognitive Battery: Traditional Chinese Version (MCCB) consists of 10 individually administered tests to measure cognitive performance in the following seven domains: Processing Speed 1.1 Trail Making Test (TMT). 1.2 Brief Assessment of Cognition in Schizophrenia: Symbol Coding (BACS SC). 1.3 Category Fluency: Animal Naming (Fluency). Attention 2.1 Continuous Performance Test: Identical Pairs (CPT-IP). Working memory 3.1 Wechsler Memory Scale-III (WMS III): Spatial Span. 3.2 Wechsler Letter: Number Sequencing (WAIS-III). Verbal Learning 4.1 Hopkins Verbal Learning Test-Revised (HVLT-R). Visual Learning 5.1 Brief Visuospatial Memory Test-Revised (BVMT-R). Reasoning and Problem Solving 6.1 Neuropsychological Assessment Battery (NAB): Mazes. Social Cognition 7.1 Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT): Managing Emotions.

Secondary Outcome Measures

Body composition
Using Body Mass Index (BMI) as the measurement of body composition, which weight and height will be combined to report BMI in kg/m^2.
Cardiorespiratory fitness
Using 6-minute walk test (6MWT) as the measurement, which let the participant walks as far as possible over a total of six minutes on hard and flat floor. And the researcher will measure the distance that participant walks in 6 minutes.
Leg muscular strength and endurance
Using 30-Second Sit to Stand Test. The participant will sit in the middle of the chair, and rise to a full standing position, then sit back down again. Repeat these movements for 30 seconds. And researcher will count the times.
Balance and Agility
The Timed Up and Go test (TUG). It measures the time that the participant takes to rise from a chair, walk eight foots, turn around, walk back to the chair, and sit down.
Dual-Task Performance Involving Hand Dexterity and Cognitive Tasks
Dual-Task Performance Involving Hand Dexterity and Cognitive Tasks, this test is combine the Purdue Pegboard Test (PPT; Tiffin & Asher, 1948) and the Serial Sevens Subtraction Test (SSST; Manning, 1982), Purdue Pegboard Test use to measures hand dexterity; Serial Sevens Subtraction Test as a cognitive task for the dual-task condition.
Instrumental Activity of Daily Living (IADL)
Lawton and Brody Instrumental Activity of Daily Living Scale is a self-report survey. It is used to evaluate the degree of participant's instrumental activities. There are total 8 descriptions, the scale scores ranges is between 0 to 8. The higher values represent a better outcome.
Schizophrenia Quality of Life Scale Revision 4 (SQLS-R4)
Schizophrenia Quality of Life Scale Revision 4 is a self-report survey. It is used to evaluate the degree of participant's quality of life. There are total 33 items, the scale scores statements are rated 1 (never) to 5 (always). The higher values represent a better outcome.

Full Information

First Posted
October 18, 2019
Last Updated
July 20, 2020
Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04143308
Brief Title
The Effects of Simultaneous Training of Walking and Cognitive Tasks on Cognitive Functions of People With Schizophrenia
Official Title
The Effects of Simultaneous Training of Walking and Cognitive Tasks on Cognitive Functions of People With Schizophrenia: the Development of Mobile Application System and Effectiveness Analysis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 5, 2019 (Actual)
Primary Completion Date
July 31, 2021 (Anticipated)
Study Completion Date
July 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The object is to develop a training system of simultaneous walking and cognitive training for improving cognitive function of people with schizophrenia. The training program, called "Simultaneous Walk And Think for Cognitive Health mobile application software"(SWATCH App), is developed by researchers. A randomized controlled trial will be carried out to test the effectiveness of the training system. Ninety participants will be randomly assigned to: simultaneous training of walking and cognitive group, the cognitive training group, and treatment as usual group. The intervention for those groups will lasts for 12 weeks, with a 12 week of followup. The measurements include the cognitive function, physical fitness, and quality of life.
Detailed Description
Background: Schizophrenia is one of the severe mental disorders. In addition to psychiatric symptoms, cognitive impairment is a key clinical feature in this population, which significantly negatively influences their functional performance and independence. While the cognitive remediation therapy demonstrates positive results, it often involves specialized and expensive computerized cognitive training system, which limits its application in clinical setting. More evidence is available to support the benefits of exercise training on cognitive functions of schizophrenia. Combination of exercise and cognitive training is a promising program and can improve cognitive functions of the elderly. However, this combined therapy is still limited to schizophrenia. Simultaneous training of walking and cognitive tasks via auditory mobile application is an innovative program for saving cost, time, and manpower. Further study is needed to develop the simultaneous training program and to examine the effectiveness. Purposes: To examine the effects of the training program on cognitive functions, fitness, functional performance and quality of life. Methods: A 3-arm, single-blinded, randomized controlled trial is used to recruit 90 participants and then randomly allocated to the simultaneous training group, the cognitive training group, and the treatment as usual group. The first two training groups receive training for 30-40 minutes, 3 times a week for 12 weeks, as well as a follow-up of 12 weeks. All participants will be assessed at baseline, post-test and follow-up assessment. Primary outcome is cognitive function and secondary outcomes are fitness, functional performance, and quality of life. Contribution: The study can be used as an evidence-based program to improve cognitive functioning of people with schizophrenia. With the development of mobile App and the use of fitness wearable device, the training program enables people with schizophrenia to walk and practice cognitive training simultaneously in a group format. It will help clinical professionals be able to serve the increasing number of people with severe mental illness with less manpower and specialized equipment. The study is also helpful to better understanding the isolated role of aerobic exercise in the dual-task training, and to apply to other groups, like the elderly or dementia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Cognitive Function, Physical Activity, Quality of Life
Keywords
Schizophrenia, Cognitive functional training, Dual-task training, Aerobic exercise, Mobile application

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
We will conduct a single-blinded, randomized controlled study. Ninety participants will be randomly assigned to: simultaneous training of walking and cognitive group, the cognitive training group, and treatment as usual group.
Masking
Participant
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Simultaneous training of walking and cognitive group
Arm Type
Experimental
Arm Description
Wearable technology (fitness wristband & App) SWATCH system (App & controller) 3 times a week (30 mins/ each time) Lasts for 12 weeks Simultaneous walking and cognitive training
Arm Title
Cognitive training group
Arm Type
Active Comparator
Arm Description
Wearable technology (fitness wristband & App) SWATCH system (App) 3 times a week (30 mins/ each time) Lasts for 12 weeks Cognitive training while sitting
Arm Title
Treatment as usual group
Arm Type
Active Comparator
Arm Description
1. Keep treatment as usual group at health care system.
Intervention Type
Other
Intervention Name(s)
Simultaneous training of walking and cognitive group
Intervention Description
Device: SWATCH system (App & controller) Wearable technology Fitness wristband & APP
Intervention Type
Other
Intervention Name(s)
Cognitive training group
Intervention Description
Device: SWATCH system (App) Wearable technology Fitness wristband & APP
Intervention Type
Other
Intervention Name(s)
Treatment as usual group
Intervention Description
Keep treatment as usual
Primary Outcome Measure Information:
Title
Cognitive function
Description
MATRICS Consensus Cognitive Battery: Traditional Chinese Version (MCCB) consists of 10 individually administered tests to measure cognitive performance in the following seven domains: Processing Speed 1.1 Trail Making Test (TMT). 1.2 Brief Assessment of Cognition in Schizophrenia: Symbol Coding (BACS SC). 1.3 Category Fluency: Animal Naming (Fluency). Attention 2.1 Continuous Performance Test: Identical Pairs (CPT-IP). Working memory 3.1 Wechsler Memory Scale-III (WMS III): Spatial Span. 3.2 Wechsler Letter: Number Sequencing (WAIS-III). Verbal Learning 4.1 Hopkins Verbal Learning Test-Revised (HVLT-R). Visual Learning 5.1 Brief Visuospatial Memory Test-Revised (BVMT-R). Reasoning and Problem Solving 6.1 Neuropsychological Assessment Battery (NAB): Mazes. Social Cognition 7.1 Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT): Managing Emotions.
Time Frame
Change from baseline outcome measure at 12th week (post-test), and at 24th week (follow-up test)
Secondary Outcome Measure Information:
Title
Body composition
Description
Using Body Mass Index (BMI) as the measurement of body composition, which weight and height will be combined to report BMI in kg/m^2.
Time Frame
Change from baseline outcome measure at 12th week (post-test), and at 24th week (follow-up test)
Title
Cardiorespiratory fitness
Description
Using 6-minute walk test (6MWT) as the measurement, which let the participant walks as far as possible over a total of six minutes on hard and flat floor. And the researcher will measure the distance that participant walks in 6 minutes.
Time Frame
Change from baseline outcome measure at 12th week (post-test), and at 24th week (follow-up test)
Title
Leg muscular strength and endurance
Description
Using 30-Second Sit to Stand Test. The participant will sit in the middle of the chair, and rise to a full standing position, then sit back down again. Repeat these movements for 30 seconds. And researcher will count the times.
Time Frame
Change from baseline outcome measure at 12th week (post-test), and at 24th week (follow-up test)
Title
Balance and Agility
Description
The Timed Up and Go test (TUG). It measures the time that the participant takes to rise from a chair, walk eight foots, turn around, walk back to the chair, and sit down.
Time Frame
Change from baseline outcome measure at 12th week (post-test), and at 24th week (follow-up test)
Title
Dual-Task Performance Involving Hand Dexterity and Cognitive Tasks
Description
Dual-Task Performance Involving Hand Dexterity and Cognitive Tasks, this test is combine the Purdue Pegboard Test (PPT; Tiffin & Asher, 1948) and the Serial Sevens Subtraction Test (SSST; Manning, 1982), Purdue Pegboard Test use to measures hand dexterity; Serial Sevens Subtraction Test as a cognitive task for the dual-task condition.
Time Frame
Change from baseline outcome measure at 12th week (post-test), and at 24th week (follow-up test)
Title
Instrumental Activity of Daily Living (IADL)
Description
Lawton and Brody Instrumental Activity of Daily Living Scale is a self-report survey. It is used to evaluate the degree of participant's instrumental activities. There are total 8 descriptions, the scale scores ranges is between 0 to 8. The higher values represent a better outcome.
Time Frame
Change from baseline outcome measure at 12th week (post-test), and at 24th week (follow-up test)
Title
Schizophrenia Quality of Life Scale Revision 4 (SQLS-R4)
Description
Schizophrenia Quality of Life Scale Revision 4 is a self-report survey. It is used to evaluate the degree of participant's quality of life. There are total 33 items, the scale scores statements are rated 1 (never) to 5 (always). The higher values represent a better outcome.
Time Frame
Change from baseline outcome measure at 12th week (post-test), and at 24th week (follow-up test)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of schizophrenia or schizoaffective disorder by a psychiatric clinician on the basis of the criteria set the Diagnostic and Statistical Manual of Mental Disorders 5th edition, DSM-5, has been more than 1 year. Age 20-60 years old. Living in daycare center or community-based mental health rehabilitation services or rehabilitation ward. Having stable psychiatric conditions (i.e., primary psychiatric medications had not changed for more than two months) The MATRICS Consensus Cognitive Battery (MCCB) (Nuechterlein et al., 2008) shows that at least one domain with cognitive impairment (below the value of -1SD). Can follow the research process and sign the consent form. Exclusion Criteria: Traumatic brain injury and other neurological diseases, alcohol and substance abuse Pregnancy, cardiovascular disease, and unsuitable to exercise training due to physical movement difficulties According participants' self-report, having following conditions, including severe heart failure, myocardial infarction, angina pectoris, chronic obstructive pulmonary disease, COPD, poor glycemic control (i.e., dialysis, diabetic neuropathy or retinopathy) and lower extremity arthritis Uncontrolled hypertension with SBP> 160 mmHg or DBP> 110 mmHg Diagnosis of intellectual disability Unconscious or confusion of consciousness Participating in other intervention studies
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ming-De Chen, Ph.D.
Phone
+886988202035
Email
mchen37@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ming-De Chen, Ph.D.
Organizational Affiliation
Department of Occupational Therapy, College of Health Sciences, Kaohsiung Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ming-De Chen
City
Kaohsiung
Country
Taiwan
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effects of Simultaneous Training of Walking and Cognitive Tasks on Cognitive Functions of People With Schizophrenia

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