NCT07643779

Brief Summary

This study is a cross-sectional research designed to investigate symptom severity, posture, musculoskeletal pain, and physical activity levels in individuals with gastroesophageal reflux disease (GERD).

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for all trials

Timeline
6mo left

Started Jul 2026

Shorter than P25 for all trials

Status
not yet recruiting

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

June 7, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 12, 2026

Completed
19 days until next milestone

Study Start

First participant enrolled

July 1, 2026

Expected
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2026

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Last Updated

June 12, 2026

Status Verified

May 1, 2026

Enrollment Period

6 months

First QC Date

June 7, 2026

Last Update Submit

June 7, 2026

Conditions

Outcome Measures

Primary Outcomes (5)

  • Gastroesophageal Reflux Disease Questionnaire (GERD-Q)

    The GERD-Q is a six-item Likert-type questionnaire that assesses the frequency of GERD-related symptoms over the past week. The first four items evaluate symptom frequency and are used for the diagnosis of the disease and monitoring treatment response. The remaining two items assess the impact of the disease on daily life, including over-the-counter medication use and sleep disturbance. Each item is scored on a four-point scale ranging from 0 to 3 according to symptom frequency. In items 1, 2, 5, and 6, scores increase from 0 to 3 with increasing symptom frequency, whereas in items 3 and 4, scoring is reversed.

    1 day

  • PROMIS GERD Scale

    The PROMIS GERD scale consists of 13 items. Each item is scored on a scale ranging from 0 to 4 points, and the total score is obtained by summing all item scores. According to the original scoring system, a score of 0 indicates no symptoms, scores of 1-3 indicate minimal symptoms, scores of 4-7 indicate mild symptoms, scores of 8-15 indicate moderate symptoms, and scores of 16 and above indicate severe symptoms.

    1 day

  • Postural Analysis

    Posture Screen Lite is a posture analysis, body composition, and movement assessment software designed for use on iOS and Android devices with built-in camera systems. In this study, posture will be assessed using the iPad-based Posture Screen Lite application. Participants will be assessed wearing appropriate clothing that leaves the upper trunk and lower legs exposed. Photographs will be taken from anterior, posterior, and right and left lateral views using a smartphone, without placing reference markers on the participant beforehand. The captured images will then be analyzed using the Posture Screen Lite software by identifying anatomical reference points on the photographs.

    1 day

  • Visual Analog Scale (VAS)

    The Visual Analog Scale (VAS) will be used to assess pain intensity. VAS has been shown to be a valid and reliable method that is sensitive to small changes in clinical pain and treatment-related pain intensity. Participants will be asked to indicate their pain level on a 10-cm horizontal line, ranging from "0" (no pain) to "10" (worst imaginable pain). In addition, participants will mark the location(s) of their pain on a body diagram to determine pain distribution and localization.

    1 day

  • International Physical Activity Questionnaire (IPAQ)

    The International Physical Activity Questionnaire (IPAQ) was developed by Craig et al. (2003) to assess physical activity levels. The short form consists of seven items and evaluates physical activity performed during the last seven days. Only activities lasting at least 10 minutes at a time are considered. Participants report the duration (in minutes) of vigorous activities (e.g., weight lifting, fast cycling, aerobic exercises, team sports), moderate activities (e.g., table tennis, folk dances, light load carrying), and walking. These values are converted into metabolic equivalent (MET) scores, and total physical activity level is calculated as MET-min/week. Based on the results, participants can be classified as inactive, minimally active, or highly active.

    1 day

Study Arms (2)

GERD patient group

Age between 18 and 65 years patient who has GERD

control group

Age between 18 and 65 years patient who has not GERD

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with and without Gastroesophageal Reflux Disease

You may qualify if:

  • Being diagnosed with gastroesophageal reflux disease (GERD)
  • Age between 18 and 65 years
  • Willingness to participate in the study assessments

You may not qualify if:

  • Presence of a diagnosed psychiatric disorder
  • Pregnancy or breastfeeding status

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Gastroesophageal RefluxMusculoskeletal PainMotor Activity

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesMuscular DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

June 7, 2026

First Posted

June 12, 2026

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

June 12, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share