Effects of Exercise on Functional Dyspepsia Based on Rome IV

NCT ID: NCT04540549

Last Updated: 2020-09-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 260 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2021-08-31

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.

Conditions

Functional Dyspepsia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

intervention group

Jogging or cycling ≥5 days/week, 30-60 min/d

Group Type: EXPERIMENTAL

exercise

Intervention Type: BEHAVIORAL

Jogging or cycling ≥5 days/week, 30-60 min/d

control group

The control group was encouraged to maintain their lifestyle.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

exercise

Jogging or cycling ≥5 days/week, 30-60 min/d

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital of Xi'an Jiaotong University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jinhai Wang, MD

Role: STUDY_DIRECTOR

Second Affiliated Hospital of Xi'an Jiaotong University

Locations

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Jinhai Wang, MD

Role: CONTACT

jinhaiwang@hotmail.com

+86-29-87679335

Zhongcao Wei, MD

Role: CONTACT

1977816504@qq.com

+86-29-18700932477

Facility Contacts

Zhongcao Wei, MD

Role: primary

1977816504@qq.com

+862987679335

Other Identifiers

2020031

Identifier Type: -

Identifier Source: org_study_id