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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Recruitment Status : Withdrawn (Couldnt find sponor for this study)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
Sponsor:
Information provided by (Responsible Party):
Taipei Medical University WanFang Hospital

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.

Condition or disease Intervention/treatment Phase
Non-alcoholic Fatty Liver Disease Other: Diaphragmatic breathing exercise Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intentional Diaphragmatic Breathing Exercise Improves the Metabolic Profiles of Patients With Non-alcoholic Fatty Liver Disease (NAFLD)
Actual Study Start Date : August 29, 2017
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : March 2018


Arm Intervention/treatment
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.
Other: Diaphragmatic breathing exercise
Through diaphragmatic breathing exercise to verify the impact of this item interventions on patients' metabolism indicators.




Primary Outcome Measures :
  1. AST and ALT [ Time Frame: Up to 3 months to collect data ]


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients who are confirmed by echo without non-alcoholic fatty liver disease and over 20 year-old, and willing to learn the exercise.

Exclusion Criteria:

  • Patients who could drop out the trial if he or she doesn't want to continue the exercise.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02863393


Sponsors and Collaborators
Taipei Medical University WanFang Hospital
Investigators
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Study Director: Ming-Shun Wu, Doctor Wanfang Hospital

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Responsible Party: Taipei Medical University WanFang Hospital
ClinicalTrials.gov Identifier: NCT02863393     History of Changes
Other Study ID Numbers: N201603004
First Posted: August 11, 2016    Key Record Dates
Last Update Posted: August 30, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases