Back to resultsEffects of 12 Weeks Walking on Cognitive Function in Schizophrenia
Primary Purpose
Schizophrenia
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
treatment-as-usual plus aerobic walking
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia
Eligibility Criteria
Inclusion Criteria:
- The patient has been diagnosed of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, fifth edition criteria (DSM-5) criteria
- The patient has the ability to complete the written informed consent
Exclusion Criteria:
- The patient has been diagnosed with organic mental disorders, intelligence disability, dementia, major depressive disorder, bipolar affective disorder, and alcohol or substance use disorder
- The patient has major systemic physical diseases, including cardiovascular diseases, uncontrollable arrhythmia, renal diseases, liver diseases or thyroid diseases
- The patient has certified as physical disability
- The patient is pregnant or has genetic diseases or infectious conditions
Sites / Locations
- Department of Psychiatry, Kaohsiung Chang Gung Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
treatment-as-usual
treatment-as-usual plus aerobic walking
Arm Description
Outcomes
Primary Outcome Measures
cognitive function change
cognitive function change assessed by Brief Assessment of Cognition in Schizophrenia
treatment change assessed by serum levels of energy metabolites (e.g., β-hydroxybutyrate)
change assessment
Secondary Outcome Measures
treatment change assessed by the Positive and Negative Syndrome Scale
minimum value 30, maximum value 210; higher scores mean a worse outcome
treatment change assessed by peripheral blood metabolic profiles (e.g., plasma cholesterol level)
change assessment
treatment change assessed by metabolic profiles (e.g., body weight in kilograms)
change assessment
treatment change assessed by serum levels of inflammatory cytokines (e.g., IL-8)
change assessment
treatment change assessed by 6-minute walk test
change assessment
Full Information
NCT ID
NCT04411979
First Posted
May 22, 2020
Last Updated
May 28, 2020
Sponsor
Chang Gung Memorial Hospital
Collaborators
Ministry of Science and Technology, Taiwan
1. Study Identification
Unique Protocol Identification Number
NCT04411979
Brief Title
Effects of 12 Weeks Walking on Cognitive Function in Schizophrenia
Official Title
Cognitive Function and Energy Metabolites in Schizophrenia: the Effect of Wearable Device-assisted Walking
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
September 27, 2018 (Actual)
Primary Completion Date
July 17, 2019 (Actual)
Study Completion Date
October 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital
Collaborators
Ministry of Science and Technology, Taiwan
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
This study is a 12-week randomized-controlled clinical trial. It will be planned to conduct in a total of 120 male and female subjects from the Department of Psychiatry at Kaohsiung Chang Gung Memorial Hospital. Eligible subjects will be psychiatric patients, aged between 20-65 years old, who have psychiatric diagnosis of schizophrenia and fulfill the inclusion and exclusion criteria. The intervention with aerobic walking programs will be initiated after randomization for patients who continue their usual treatment. Subjects will be enrolled for 12 weeks aerobic walking treatment and randomly assigned to (1) treatment-as-usual, (2) treatment-as-usual plus aerobic walking. We will measure the treatment response to clarify the effect of aerobic walking in patients with schizophrenia. This study is being performed to investigate the possibly beneficial effects of aerobic walking on cognitive function and energy metabolites in schizophrenia.
Detailed Description
This 12-week randomized-controlled clinical trial will be planned to conduct in a total of 120 male and female subjects from the Department of Psychiatry at Kaohsiung Chang Gung Memorial Hospital. Eligible subjects will be psychiatric patients, aged between 20-65 years old, who have psychiatric diagnosis of schizophrenia and fulfill the inclusion and exclusion criteria. The intervention with aerobic walking programs will be initiated after randomization for patients who continue their usual treatment. Subjects will be enrolled for 12 weeks aerobic walking treatment and randomly assigned to (1) treatment-as-usual, (2) treatment-as-usual plus aerobic walking. The wearable watch will be used during the participants join the walking programs. We will measure the treatment response to investigate the effect of aerobic walking in patients with schizophrenia. This study is being performed to investigate the possibly beneficial effects of aerobic walking on cognitive function in schizophrenia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
85 (Actual)
8. Arms, Groups, and Interventions
Arm Title
treatment-as-usual
Arm Type
No Intervention
Arm Title
treatment-as-usual plus aerobic walking
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
treatment-as-usual plus aerobic walking
Intervention Description
aerobic walking
Primary Outcome Measure Information:
Title
cognitive function change
Description
cognitive function change assessed by Brief Assessment of Cognition in Schizophrenia
Time Frame
week 12
Title
treatment change assessed by serum levels of energy metabolites (e.g., β-hydroxybutyrate)
Description
change assessment
Time Frame
week 12
Secondary Outcome Measure Information:
Title
treatment change assessed by the Positive and Negative Syndrome Scale
Description
minimum value 30, maximum value 210; higher scores mean a worse outcome
Time Frame
week 12
Title
treatment change assessed by peripheral blood metabolic profiles (e.g., plasma cholesterol level)
Description
change assessment
Time Frame
week 12
Title
treatment change assessed by metabolic profiles (e.g., body weight in kilograms)
Description
change assessment
Time Frame
week 6, week 12
Title
treatment change assessed by serum levels of inflammatory cytokines (e.g., IL-8)
Description
change assessment
Time Frame
week 12
Title
treatment change assessed by 6-minute walk test
Description
change assessment
Time Frame
week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The patient has been diagnosed of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, fifth edition criteria (DSM-5) criteria
The patient has the ability to complete the written informed consent
Exclusion Criteria:
The patient has been diagnosed with organic mental disorders, intelligence disability, dementia, major depressive disorder, bipolar affective disorder, and alcohol or substance use disorder
The patient has major systemic physical diseases, including cardiovascular diseases, uncontrollable arrhythmia, renal diseases, liver diseases or thyroid diseases
The patient has certified as physical disability
The patient is pregnant or has genetic diseases or infectious conditions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yu-Chi Huang, MD
Organizational Affiliation
Department of Psychiatry, Kaohsiung Chang Gung Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Psychiatry, Kaohsiung Chang Gung Memorial Hospital
City
Kaohsiung
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
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Effects of 12 Weeks Walking on Cognitive Function in Schizophrenia
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