Effects of Exercise on Functional Dyspepsia Based on Rome IV

Study Overview
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Brief Summary
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Functional dyspepsia is one of the most common gastrointestinal disorders (FGIDs) encountered in clinical practice. Functional dyspepsia is a clinical syndrome characterized by chronic and recurrent gastroduodenal symptoms in the absence of any organic or metabolic disease that is likely to explain the symptoms. Functional dyspepsia has a high incidence in the population. A recent research showed that FD is present in 11% of the Italian general population. It dramatically reduces a patient's quality of life, with an economic impact due to frequent clinical consultations, medication, and time off work. Although some experts recommend exercise as a first-line treatment for functional dyspepsia, there is little data on the relationship between exercise and functional dyspepsia, which needs to be confirmed by further research. Investigators designed this randomized controlled study to assess the effect of exercise on patients with functional dyspepsia based on Rome IV criteria.

Detailed Description
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Functional dyspepsia is one of the most common gastrointestinal disorders (FGIDs) encountered in clinical practice. Functional dyspepsia is a clinical syndrome characterized by chronic and recurrent gastroduodenal symptoms in the absence of any organic or metabolic disease that is likely to explain the symptoms. Functional dyspepsia has a high incidence in the population. A recent research showed that FD is present in 11% of the Italian general population. It dramatically reduces a patient's quality of life, with an economic impact due to frequent clinical consultations, medication, and time off work. Regular physical activity and exercise may be a way of life to reduce low levels of inflammation throughout the body, thereby reducing the risk of developing chronic diseases. Multiple studies have shown that after regular exercise, markers of inflammation and oxidative stress are reduced, while markers of inflammation and antioxidants are increased, reflecting the anti-inflammatory and antioxidant properties of exercise. Rome IV was introduced in 2016. Rome IV introduced more precisely define the minimal thresholds for frequency and severity of each individual symptom, primarily for scientific purposes, but data still need to be collected to define thresholds based on the frequency and/or severity of symptoms that impair quality of life. Although some experts recommend exercise as a first-line treatment for functional dyspepsia, there is little data on the relationship between exercise and functional dyspepsia, which needs to be confirmed by further research. Investigators designed this randomized controlled study to assess the effect of exercise on patients with functional dyspepsia based on Rome IV criteria.

Official Title
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Effects of Exercise on Patients With Functional Dyspepsia Based on Rome IV Criteria

Conditions
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Functional Dyspepsia

Intervention / Treatment
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* Behavioral: exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years old Functional dyspepsia meeting Rome IV criteria Gastroscope, blood routine, liver function and Hp examination were performed within the last year, and the results were normal No prokinetic drug, proton pump inhibitor or mucosal protective agent was used in the last two weeks Sign informed consent and be willing to participate in this study Exclusion Criteria: There are organic diseases that may explain the symptoms, such as peptic ulcer, gastrointestinal neoplasms, history of hepatobiliary and pancreatic diseases, history of tumor diseases, and history of metabolic diseases Pregnancy, prepregnancy, or lactation History of abdominal surgery Mental illness Severe impairment of heart, liver, or kidney function or respiratory function Recent use of antidepressant, hormone, NSAIDs The main symptoms are gastroesophageal reflux disease or irritable bowel syndrome Failure to increase exercise levels

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention group<br>Jogging or cycling ≥5 days/week, 30-60 min/d | Behavioral: exercise<br>* Jogging or cycling ≥5 days/week, 30-60 min/d<br>|
| No Intervention: control group<br>The control group was encouraged to maintain their lifestyle. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weekly global symptom assessment | Patients are asked to answer the following yes/no question once a week: In the past 7 days, have you had adequate relief of your stomach symptoms? | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eight items of dyspepsia symptom score questionnaire(epigastric pain, epigastric burning, postprandial fullness, early satiety, belching, bloating, nausea, and vomiting) | severity(0=absent; 1=mild; 2=moderate); frequency (1 = less than once per week; 2 = once per week; 3 = two to three times per week; 4 = four to five times per week; 5 = daily) 3=severe and interfering with daily activities | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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functional dyspepsia, exercise, Rome IV