The Effects of Simultaneous Training of Walking and Cognitive Tasks on Cognitive Functions of People With Schizophrenia
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|ClinicalTrials.gov Identifier: NCT04143308|
Recruitment Status : Not yet recruiting
First Posted : October 29, 2019
Last Update Posted : October 29, 2019
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia Cognitive Function Physical Activity Quality of Life||Other: Simultaneous training of walking and cognitive group Other: Cognitive training group Other: Treatment as usual group||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Intervention 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.|
|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|
|Estimated Study Start Date :||November 1, 2019|
|Estimated Primary Completion Date :||July 31, 2021|
|Estimated Study Completion Date :||July 31, 2021|
Experimental: Simultaneous training of walking and cognitive group
Other: Simultaneous training of walking and cognitive group
Active Comparator: Cognitive training group
Other: Cognitive training group
Active Comparator: Treatment as usual group
1. Keep treatment as usual group at health care system.
Other: Treatment as usual group
Keep treatment as usual
- Cognitive function [ Time Frame: Change from baseline outcome measure at 12th week (post-test), and at 24th week (follow-up test) ]
MATRICS Consensus Cognitive Battery: Traditional Chinese Version (MCCB) consists of 10 individually administered tests to measure cognitive performance in the following seven domains:
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).
2.1 Continuous Performance Test: Identical Pairs (CPT-IP).
3.1 Wechsler Memory Scale-III (WMS III): Spatial Span.
3.2 Wechsler Letter: Number Sequencing (WAIS-III).
4.1 Hopkins Verbal Learning Test-Revised (HVLT-R).
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.
- Body composition [ Time Frame: Change from baseline outcome measure at 12th week (post-test), and at 24th week (follow-up test) ]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 [ Time Frame: Change from baseline outcome measure at 12th week (post-test), and at 24th week (follow-up test) ]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 [ Time Frame: Change from baseline outcome measure at 12th week (post-test), and at 24th week (follow-up test) ]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 [ Time Frame: Change from baseline outcome measure at 12th week (post-test), and at 24th week (follow-up test) ]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 [ Time Frame: Change from baseline outcome measure at 12th week (post-test), and at 24th week (follow-up test) ]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) [ Time Frame: Change from baseline outcome measure at 12th week (post-test), and at 24th week (follow-up test) ]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) [ Time Frame: Change from baseline outcome measure at 12th week (post-test), and at 24th week (follow-up test) ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04143308
|Contact: Ming-De Chen, Ph.D.||+firstname.lastname@example.org|
|Principal Investigator:||Ming-De Chen, Ph.D.||Department of Occupational Therapy, College of Health Sciences, Kaohsiung Medical University|