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

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04143308
• Other study ID #: KMUHIRB-SV(I)-20170080
• Status: Completed
• Phase: N/A
• Start date: November 5, 2019
• Est. completion date: July 7, 2021

Study information

• Verified date: September 2021
• Source: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: July 7, 2021
• Est. primary completion date: July 7, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Function
• Physical Activity
• Quality of Life
• Schizophrenia

Intervention

Other:
• Simultaneous training of walking and cognitive group
Device: SWATCH system (App & controller) Wearable technology Fitness wristband & APP
• Cognitive training group
Device: SWATCH system (App) Wearable technology Fitness wristband & APP
• Treatment as usual group
Keep treatment as usual

Locations

Country	Name	City	State
Taiwan	Ming-De Chen	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from baseline outcome measure at 12th week (post-test), and at 24th week (follow-up test)
Secondary	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.	Change from baseline outcome measure at 12th week (post-test), and at 24th week (follow-up test)
Secondary	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.	Change from baseline outcome measure at 12th week (post-test), and at 24th week (follow-up test)
Secondary	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.	Change from baseline outcome measure at 12th week (post-test), and at 24th week (follow-up test)
Secondary	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.	Change from baseline outcome measure at 12th week (post-test), and at 24th week (follow-up test)
Secondary	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; Tif?n & 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.	Change from baseline outcome measure at 12th week (post-test), and at 24th week (follow-up test)
Secondary	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.	Change from baseline outcome measure at 12th week (post-test), and at 24th week (follow-up test)
Secondary	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.	Change from baseline outcome measure at 12th week (post-test), and at 24th week (follow-up test)