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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04411979
Other study ID # MOST 107-2635-B-182A-002
Secondary ID 201702283A3C601
Status Completed
Phase N/A
First received
Last updated
Start date September 27, 2018
Est. completion date October 15, 2019

Study information

Verified date February 2018
Source Chang Gung Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 85
Est. completion date October 15, 2019
Est. primary completion date July 17, 2019
Accepts healthy volunteers No
Gender All
Age group 20 Years to 65 Years
Eligibility Inclusion Criteria:

1. The patient has been diagnosed of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, fifth edition criteria (DSM-5) criteria

2. The patient has the ability to complete the written informed consent

Exclusion Criteria:

1. The patient has been diagnosed with organic mental disorders, intelligence disability, dementia, major depressive disorder, bipolar affective disorder, and alcohol or substance use disorder

2. The patient has major systemic physical diseases, including cardiovascular diseases, uncontrollable arrhythmia, renal diseases, liver diseases or thyroid diseases

3. The patient has certified as physical disability

4. The patient is pregnant or has genetic diseases or infectious conditions

Study Design


Related Conditions & MeSH terms


Intervention

Other:
treatment-as-usual plus aerobic walking
aerobic walking

Locations

Country Name City State
Taiwan Department of Psychiatry, Kaohsiung Chang Gung Memorial Hospital Kaohsiung

Sponsors (2)

Lead Sponsor Collaborator
Chang Gung Memorial Hospital Ministry of Science and Technology, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary cognitive function change cognitive function change assessed by Brief Assessment of Cognition in Schizophrenia week 12
Primary treatment change assessed by serum levels of energy metabolites (e.g., ß-hydroxybutyrate) change assessment week 12
Secondary treatment change assessed by the Positive and Negative Syndrome Scale minimum value 30, maximum value 210; higher scores mean a worse outcome week 12
Secondary treatment change assessed by peripheral blood metabolic profiles (e.g., plasma cholesterol level) change assessment week 12
Secondary treatment change assessed by metabolic profiles (e.g., body weight in kilograms) change assessment week 6, week 12
Secondary treatment change assessed by serum levels of inflammatory cytokines (e.g., IL-8) change assessment week 12
Secondary treatment change assessed by 6-minute walk test change assessment week 12
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