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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intervention group | Experimental | Jogging or cycling ≥5 days/week, 30-60 min/d |
|
| control group | No Intervention | The control group was encouraged to maintain their lifestyle. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| exercise | Behavioral | Jogging or cycling ≥5 days/week, 30-60 min/d |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jinhai Wang, MD | Contact | +86-29-87679335 | jinhaiwang@hotmail.com | |
| Zhongcao Wei, MD | Contact | +86-29-18700932477 | 1977816504@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Jinhai Wang, MD | Second Affiliated Hospital of Xi'an Jiaotong University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Xi'an Jiaotong University | Recruiting | Xi'an | 710004 | China |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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