Cognitive and Balance Dual Task Training for People With Schizophrenia

NCT05341804 | Completed

• 1 other identifier: KMUHIRB-F(I)-20210071
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Schizophrenia; Cognition; Balance; Dual Task; Mental Illness; Psychiatric Disorder; Fall Prevention

Outcome Measures

Primary Outcomes (5)

• Mini-Balance Evaluation System Test

  score from 0-28; higher score is better

  Change from baseline at 12 weeks

• Timed up and go test under single and dual tasks

  dual tasks include carrying a cup of water and calculation

  Change from baseline at 12 weeks

• Single leg stance test under single and dual tasks

  dual tasks include carrying a cup of water and calculation

  Change from baseline at 12 weeks

• Chinese version of Activities-specific Balance Confidence Scale

  score from 0-100; higher score is better

  Change from baseline at 12 weeks

• 6 meter walk test

  Change from baseline at 12 weeks

Secondary Outcomes (7)

• 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

Study Arms (3)

the cognitive and balance dual task training group

EXPERIMENTAL

It is performed using the CogBals software, emphasizing the completion of cognitive tasks while performing balance/strength training during the training process.

Behavioral: cognitive and balance dual task training

the balance training group

EXPERIMENTAL

Balance/strength training without cognitive challenges.

Behavioral: balance training

the treatment as usual group

NO INTERVENTION

Maintain usual rehabilitation activities.

Interventions

cognitive and balance dual task training BEHAVIORAL

a cognitive and balance dual task training program involving the Internet of Thing technique software - Cognitive and Balance training Simultaneously software

Also known as: Use Cognitive and Balance training Simultaneously software (CogBals)

the cognitive and balance dual task training group

balance training BEHAVIORAL

Includes static balance, dynamic balance and strength training

the balance training group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kaohsiung Medical University Chung-Ho Memorial Hospital: lead
• Kaohsiung Medical University: collaborator
• Ministry of Science and Technology, Taiwan: collaborator

Study Sites (1)

Kaohsiung Medical University

Kaohsiung City, 807, Taiwan

Location

MeSH Terms

Conditions

Schizophrenia; Mental Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders

Study Design

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

Model Details: the cognitive and balance dual task training group (COG\&BAL), the balance training group (BAL), and the treatment as usual group

Study Record Dates

• First Submitted: April 5, 2022
• First Posted: April 22, 2022
• Study Start: May 10, 2022
• Primary Completion: September 15, 2023
• Study Completion: September 15, 2023
• Last Updated: June 21, 2024

Record last verified: 2024-04

Locations

TW (1)