Diaphragmatic Breathing Exercise Improves Non-alcoholic Fatty Liver Disease
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ClinicalTrials.gov Identifier: NCT02863393 |
Recruitment Status :
Withdrawn
(Couldnt find sponor for this study)
First Posted : August 11, 2016
Last Update Posted : August 30, 2017
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Sponsor:
Taipei Medical University WanFang Hospital
Information provided by (Responsible Party):
Taipei Medical University WanFang Hospital
Tracking Information | |||||
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First Submitted Date ICMJE | June 28, 2016 | ||||
First Posted Date ICMJE | August 11, 2016 | ||||
Last Update Posted Date | August 30, 2017 | ||||
Actual Study Start Date ICMJE | August 29, 2017 | ||||
Estimated Primary Completion Date | January 2018 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
AST and ALT [ Time Frame: Up to 3 months to collect data ] | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Diaphragmatic Breathing Exercise Improves Non-alcoholic Fatty Liver Disease | ||||
Official Title ICMJE | Intentional Diaphragmatic Breathing Exercise Improves the Metabolic Profiles of Patients With Non-alcoholic Fatty Liver Disease (NAFLD) | ||||
Brief Summary | The non-alcoholic fatty liver disease is increasing and associated with obesity, diabetes and hyperlipidemia in recent years. Aerobic exercise indeed reduces adipose, hepatic insulin resistance and hepatic fat. However, diaphragmatic breathing improves cardiopulmonary function, the oxygen content of the body and therefore reduces inflammation of cells. The aim of this study is to ameliorate hepatic inflammation by using diaphragmatic breathing exercises instead of aerobic exercise to reduce the fat in liver inflammation. | ||||
Detailed Description | The non-alcoholic fatty liver disease is increasing and associated with obesity, diabetes and hyperlipidemia in recent years. Aerobic exercise indeed reduces adipose, hepatic insulin resistance and hepatic fat. However, diaphragmatic breathing improves cardiopulmonary function, the oxygen content of the body and therefore reduces inflammation of cells. The aim of this study is to ameliorate hepatic inflammation by using diaphragmatic breathing exercises instead of aerobic exercise to reduce the fat in liver inflammation. The project intends to be accomplished within three years because of the ideal exercise leaves an uncertain question for curing non-alcoholic fatty liver disease. Hence, with the literature and empirical data analysis to review and identify the strength of patients' motion and duration, carry out a pilot observational study by including 20 patients, then teach diaphragmatic breathing exercises in the first year of the project. Observe the initial correlation measurement, the variables of the following one month and three months. For the second year, develop the training of diaphragmatic breathing process with assisting device (Diaphragmatic breathing-facilitated exercise device). Use diaphragmatic breathing exercise assisting device in a 12-week program of diaphragmatic breathing on randomized clinical trial, verifying the impact of this item interventions on patients' metabolism indicators in the final year.The project includes people who are over 20 years old without the non-alcoholic fatty liver disease. Taking liver function, body mass index, the thickness of subcutaneous fat, heart rate variability, metabolism indicators are mainly study measured variables. Regression Analysis helps understand the correlation between breathing exercise and indicators related to the disease. With the intervention of diaphragmatic breathing assist device, the program extensions to the two-factor analysis of variance (two-way ANOVA) as the results of verification. The study results can provide a reference for clinicians, thereby improving the prognosis of non-alcoholic fatty liver disease people. | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Non-alcoholic Fatty Liver Disease | ||||
Intervention ICMJE | Other: Diaphragmatic breathing exercise
Through diaphragmatic breathing exercise to verify the impact of this item interventions on patients' metabolism indicators.
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Study Arms ICMJE | Experimental: Diaphragmatic breathing exercise
The aim of this study is to ameliorate hepatic inflammation by using diaphragmatic breathing exercises instead of aerobic exercise to reduce the fat in liver inflammation.
Intervention: Other: Diaphragmatic breathing exercise
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Withdrawn | ||||
Actual Enrollment ICMJE |
0 | ||||
Original Estimated Enrollment ICMJE |
20 | ||||
Estimated Study Completion Date ICMJE | March 2018 | ||||
Estimated Primary Completion Date | January 2018 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 20 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Not Provided | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT02863393 | ||||
Other Study ID Numbers ICMJE | N201603004 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Taipei Medical University WanFang Hospital | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Taipei Medical University WanFang Hospital | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Taipei Medical University WanFang Hospital | ||||
Verification Date | April 2017 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |