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

NCT04143308 | Completed

• 1 other identifier: KMUHIRB-SV(I)-20170080
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia; Cognitive Function; Physical Activity; Quality of Life

Keywords

Schizophrenia; Cognitive functional training; Dual-task training; Aerobic exercise; Mobile application

Outcome Measures

Primary Outcomes (1)

• 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: 1. 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). 2. Attention 2.1 Continuous Performance Test: Identical Pairs (CPT-IP). 3. Working memory 3.1 Wechsler Memory Scale-III (WMS III): Spatial Span. 3.2 Wechsler Letter: Number Sequencing (WAIS-III). 4. Verbal Learning 4.1 Hopkins Verbal Learning Test-Revised (HVLT-R). 5. Visual Learning 5.1 Brief Visuospatial Memory Test-Revised (BVMT-R). 6. Reasoning and Problem Solving 6.1 Neuropsychological Assessment Battery (NAB): Mazes. 7. 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 Outcomes (7)

• Body composition

  Change from baseline outcome measure at 12th week (post-test), and at 24th week (follow-up test)

• Cardiorespiratory fitness

  Change from baseline outcome measure at 12th week (post-test), and at 24th week (follow-up test)

• Leg muscular strength and endurance

  Change from baseline outcome measure at 12th week (post-test), and at 24th week (follow-up test)

• Balance and Agility

  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

  Change from baseline outcome measure at 12th week (post-test), and at 24th week (follow-up test)

Study Arms (3)

Simultaneous training of walking and cognitive group

EXPERIMENTAL

1. Wearable technology (fitness wristband \& App) 2. SWATCH system (App \& controller) 3. 3 times a week (30 mins/ each time) 4. Lasts for 12 weeks 5. Simultaneous walking and cognitive training

Other: Simultaneous training of walking and cognitive group

Cognitive training group

ACTIVE COMPARATOR

1. Wearable technology (fitness wristband \& App) 2. SWATCH system (App) 3. 3 times a week (30 mins/ each time) 4. Lasts for 12 weeks 5. Cognitive training while sitting

Other: Cognitive training group

Treatment as usual group

ACTIVE COMPARATOR

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

Other: Treatment as usual group

Interventions

Simultaneous training of walking and cognitive group OTHER

Device: 1. SWATCH system (App \& controller) 2. Wearable technology Fitness wristband \& APP

Simultaneous training of walking and cognitive group

Cognitive training group OTHER

Device: 1. SWATCH system (App) 2. Wearable technology Fitness wristband \& APP

Cognitive training group

Treatment as usual group OTHER

Keep treatment as usual

Treatment as usual group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Kaohsiung Medical University Chung-Ho Memorial Hospital: lead

Study Sites (1)

Ming-De Chen

Kaohsiung City, Taiwan

Location

MeSH Terms

Conditions

Schizophrenia; Motor Activity

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Behavior

Study Officials

• Ming-De Chen, Ph.D.

  Department of Occupational Therapy, College of Health Sciences, Kaohsiung Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 18, 2019
• First Posted: October 29, 2019
• Study Start: November 5, 2019
• Primary Completion: July 7, 2021
• Study Completion: July 7, 2021
• Last Updated: June 21, 2024

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)