Effects of Exercise on Functional Dyspepsia Based on Rome IV
Primary Purpose
Functional Dyspepsia
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
exercise
Sponsored by
About this trial
This is an interventional treatment trial for Functional Dyspepsia focused on measuring functional dyspepsia, exercise, Rome IV
Eligibility Criteria
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
Sites / Locations
- The Second Affiliated Hospital of Xi'an Jiaotong UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
intervention group
control group
Arm Description
Jogging or cycling ≥5 days/week, 30-60 min/d
The control group was encouraged to maintain their lifestyle.
Outcomes
Primary Outcome Measures
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?"
Secondary Outcome Measures
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
Full Information
NCT ID
NCT04540549
First Posted
August 29, 2020
Last Updated
September 12, 2020
Sponsor
Second Affiliated Hospital of Xi'an Jiaotong University
1. Study Identification
Unique Protocol Identification Number
NCT04540549
Brief Title
Effects of Exercise on Functional Dyspepsia Based on Rome IV
Official Title
Effects of Exercise on Patients With Functional Dyspepsia Based on Rome IV Criteria
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
August 31, 2021 (Anticipated)
Study Completion Date
August 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital of Xi'an Jiaotong University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Dyspepsia
Keywords
functional dyspepsia, exercise, Rome IV
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
260 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
intervention group
Arm Type
Experimental
Arm Description
Jogging or cycling ≥5 days/week, 30-60 min/d
Arm Title
control group
Arm Type
No Intervention
Arm Description
The control group was encouraged to maintain their lifestyle.
Intervention Type
Behavioral
Intervention Name(s)
exercise
Intervention Description
Jogging or cycling ≥5 days/week, 30-60 min/d
Primary Outcome Measure Information:
Title
Weekly global symptom assessment
Description
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?"
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Eight items of dyspepsia symptom score questionnaire(epigastric pain, epigastric burning, postprandial fullness, early satiety, belching, bloating, nausea, and vomiting)
Description
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
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jinhai Wang, MD
Phone
+86-29-87679335
Email
jinhaiwang@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zhongcao Wei, MD
Phone
+86-29-18700932477
Email
1977816504@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jinhai Wang, MD
Organizational Affiliation
Second Affiliated Hospital of Xi'an Jiaotong University
Official's Role
Study Director
Facility Information:
Facility Name
The Second Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
ZIP/Postal Code
710004
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhongcao Wei, MD
Phone
+862987679335
Email
1977816504@qq.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Effects of Exercise on Functional Dyspepsia Based on Rome IV
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