Effects of Exercise on Functional Dyspepsia Based on Rome IV

Effects 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. 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.

Study Overview

• Status: Unknown
• Conditions: Functional Dyspepsia
• Intervention / Treatment: Behavioral: exercise

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.

• Study Type: Interventional
• Enrollment (Anticipated): 260
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jinhai Wang, MD; Phone Number: +86-29-87679335; Email: jinhaiwang@hotmail.com

Study Locations

• China
  • Xi'an, China, 710004
    • Recruiting
    • The Second Affiliated Hospital of Xi'an Jiaotong University
    • Contact: Zhongcao Wei, MD; Phone Number: +862987679335; Email: 1977816504@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age ≥18 years old
2. Functional dyspepsia meeting Rome IV criteria
3. Gastroscope, blood routine, liver function and Hp examination were performed within the last year, and the results were normal
4. No prokinetic drug, proton pump inhibitor or mucosal protective agent was used in the last two weeks
5. Sign informed consent and be willing to participate in this study

Exclusion Criteria:

1. 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
2. Pregnancy, prepregnancy, or lactation
3. History of abdominal surgery
4. Mental illness
5. Severe impairment of heart, liver, or kidney function or respiratory function
6. Recent use of antidepressant, hormone, NSAIDs
7. The main symptoms are gastroesophageal reflux disease or irritable bowel syndrome
8. Failure to increase exercise levels

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital of Xi'an Jiaotong University
• Investigators: Study Director: Jinhai Wang, MD, Second Affiliated Hospital of Xi'an JiaoTong University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Anticipated): August 31, 2021
• Study Completion (Anticipated): August 31, 2021

Study Registration Dates

• First Submitted: August 29, 2020
• First Submitted That Met QC Criteria: September 1, 2020
• First Posted (Actual): September 7, 2020

Study Record Updates

• Last Update Posted (Actual): September 16, 2020
• Last Update Submitted That Met QC Criteria: September 12, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: functional dyspepsia, exercise, Rome IV
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Dyspepsia
• Other Study ID Numbers: 2020031

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No