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NCT Number: NCT04411979

Effects of 12 Weeks Walking on Cognitive Function in Schizophrenia

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.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Psychiatry, Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

treatment-as-usual plus aerobic walking

Other

aerobic walking

Primary outcomes

  1. cognitive function change

    Time frame: week 12

    cognitive function change assessed by Brief Assessment of Cognition in Schizophrenia

  2. treatment change assessed by serum levels of energy metabolites (e.g., β-hydroxybutyrate)

    Time frame: week 12

    change assessment

Secondary outcomes

  1. treatment change assessed by the Positive and Negative Syndrome Scale

    Time frame: week 12

    minimum value 30, maximum value 210; higher scores mean a worse outcome

  2. treatment change assessed by peripheral blood metabolic profiles (e.g., plasma cholesterol level)

    Time frame: week 12

    change assessment

  3. treatment change assessed by metabolic profiles (e.g., body weight in kilograms)

    Time frame: week 6, week 12

    change assessment

  4. treatment change assessed by serum levels of inflammatory cytokines (e.g., IL-8)

    Time frame: week 12

    change assessment

  5. treatment change assessed by 6-minute walk test

    Time frame: week 12

    change assessment

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Collaborators

  • Ministry of Science and Technology, Taiwan

Registry information

Official study title

Cognitive Function and Energy Metabolites in Schizophrenia: the Effect of Wearable Device-assisted Walking

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 2, 2020
Registry last updated
Jun 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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