Viewing Study NCT04540549



Ignite Creation Date: 2024-05-06 @ 3:11 PM
Last Modification Date: 2024-10-26 @ 1:44 PM
Study NCT ID: NCT04540549
Status: UNKNOWN
Last Update Posted: 2020-09-16
First Post: 2020-08-29

Brief Title: Effects of Exercise on Functional Dyspepsia Based on Rome IV
Sponsor: Second Affiliated Hospital of Xian Jiaotong University
Organization: Second Affiliated Hospital of Xian Jiaotong University

Study Overview

Official Title: Effects of Exercise on Patients With Functional Dyspepsia Based on Rome IV Criteria
Status: UNKNOWN
Status Verified Date: 2020-09
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 patients 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 patients 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 andor 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None