NCT04540549

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
260

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 29, 2020

Completed
3 days until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 7, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2021

Completed
Last Updated

September 16, 2020

Status Verified

September 1, 2020

Enrollment Period

12 months

First QC Date

August 29, 2020

Last Update Submit

September 12, 2020

Conditions

Functional Dyspepsia

Keywords

functional dyspepsia, exercise, Rome IV

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Eight items of dyspepsia symptom score questionnaire(epigastric pain, epigastric burning, postprandial fullness, early satiety, belching, bloating, nausea, and vomiting)

    12 weeks

Study Arms (2)

intervention group

EXPERIMENTAL

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

Behavioral: exercise

control group

NO INTERVENTION

The control group was encouraged to maintain their lifestyle.

Interventions

exerciseBEHAVIORAL

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

intervention group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, 710004, China

RECRUITING

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Jinhai Wang, MD

    Second Affiliated Hospital of Xi'an Jiaotong University

    STUDY DIRECTOR

Central Study Contacts

Jinhai Wang, MD

CONTACT

+86-29-87679335jinhaiwang@hotmail.com

Zhongcao Wei, MD

CONTACT

+86-29-187009324771977816504@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2020

First Posted

September 7, 2020

Study Start

September 1, 2020

Primary Completion

August 31, 2021

Study Completion

August 31, 2021

Last Updated

September 16, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)