Non-alcoholic Fatty Liver DiseaseNCT02863393
Diaphragmatic Breathing Exercise Improves Non-alcoholic Fatty Liver Disease
A study testing Diaphragmatic breathing exercise in people with Non-alcoholic Fatty Liver Disease, run by Taipei Medical University WanFang Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Non-alcoholic Fatty Liver Disease
- What is being tested?
- Diaphragmatic breathing exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 29 Aug 2017to Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who are confirmed by echo without non-alcoholic fatty liver disease and over 20 year-old, and willing to learn the exercise.
Who cannot join
- Patients who could drop out the trial if he or she doesn't want to continue the exercise.
About this study
Official title: Intentional Diaphragmatic Breathing Exercise Improves the Metabolic Profiles of Patients With Non-alcoholic Fatty Liver Disease (NAFLD)
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.
Read the 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.
- Conditions
- Non-alcoholic Fatty Liver Disease
- Being tested
- Diaphragmatic breathing exercise
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diaphragmatic breathing exerciseOther
Through diaphragmatic breathing exercise to verify the impact of this item interventions on patients' metabolism indicators.
| Study group | Role | What they receive |
|---|---|---|
| Diaphragmatic breathing exercise | Experimental | 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. Receives: Other: Diaphragmatic breathing exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
AST and ALT
Measured: Up to 3 months to collect data
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2016 (estimated)
- Study start29 Aug 2017
- Primary completionJan 2018 (estimated)
- Study completionMar 2018 (estimated)
Why it stopped: Couldnt find sponor for this study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University WanFang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ming-Shun Wu, Doctor, Study director, Wanfang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02863393
- Sponsor's protocol ID
- N201603004
- Status last verified
- Apr 2017
- First submitted
- 28 Jun 2016
- Last updated
- 30 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intentional Diaphragmatic Breathing Exercise Improves the Metabolic Profiles of Patients With Non-alcoholic Fatty Liver Disease (NAFLD)
- ClinicalTrials.gov ID
- NCT02863393
- Acronym / sponsor ID
- N201603004
- Conditions
- Non-alcoholic Fatty Liver Disease
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Couldnt find sponor for this study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Taipei Medical University WanFang HospitalUniversity, hospital or other
- Study start
- 29 Aug 2017 (actual)
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 11 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diaphragmatic breathing exercise | Experimental | Other: Diaphragmatic breathing exerciseThe 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who are confirmed by echo without non-alcoholic fatty liver disease and over 20 year-old, and willing to learn the exercise.
Key exclusion criteria (1 listed)
- Patients who could drop out the trial if he or she doesn't want to continue the exercise.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diaphragmatic breathing exerciseThrough diaphragmatic breathing exercise to verify the impact of this item interventions on patients' metabolism indicators. | Other | Diaphragmatic breathing exercise |
Primary outcome
AST and ALT
Time frame: Up to 3 months to collect data
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ming-Shun Wu, Doctor study director
Wanfang Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Diaphragmatic breathing exercise in people with Non-alcoholic Fatty Liver Disease, run by Taipei Medical University WanFang Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 30 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AST and ALT (time frame: Up to 3 months to collect data). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2017.