Brain-Gut Yoga for Functional Dyspepsia and Gastroparesis (FD-GP) (FD-GP)

July 24, 2026 updated by: Wake Forest University Health Sciences

Adaptation of the Yoga Skills Training for Relief of Nausea and Vomiting in Patients With Functional Dyspepsia and Gastroparesis

The purpose of this research study is to assess whether using a yoga-based intervention in practice is feasible (possible) and acceptable to patients with Functional Dyspepsia and/or Gastroparesis (FD-GP).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This research looks to adapt an existing seated yoga intervention, designed for patients with GI cancer, for testing in patients with disorders of the upper GI tract by conducting a field test with FD-GP patients to assess feasibility and acceptability and refine the adapted intervention.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Atrium Health Gastroenterology and Hepatology Kenilworth

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18 years and older
  • Functional Dyspepsia or Gastroparesis (FP or GP) diagnosed by a physician using standard criteria
  • Signed, written consent

Exclusion Criteria:

  • Co-morbid Gastrointestinal or related disorders documents in the medical record: celiac disease, inflammatory Bowel Disease(active), gastrointestinal obstruction (if current in the last 6 months), any GI surgery within the last 6 months), chronic pancreatitis or any pancreatic or biliary disease, cirrhosis or any chronic liver disease other than metabolic associated hepatic disease (MASH), any malignancy (except skin cancer already resected and surgically in remission)
  • A positive screen for the following: current psychotic symptoms, elevated suicide risk, active eating disorder, cognitive impairment, current harmful alcohol or substance use
  • Does not understand English
  • Underwent a regular yoga or other mediative movement practice (tai chi or qi gong) in the past 6 month

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Seated Yoga Intervention
Two one-hour yoga sessions with home practice administered individually by a yoga interventionist in GI clinic
Other: Seated Yoga Skills Training in Functional Dyspepsia and Gastroparesis (FD-GP)
Two one-hour chair-based yoga sessions that will include gentle movements, breathing practices, and meditation, along with home practice.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Screening Rate
Time Frame: Week 0
Tracking the number of screened participants, those who are eligible, and the percent who agree to participate.
Week 0
Recruitment Rate
Time Frame: Week 0
Total number of patients who enrolled and proportion of patients eligible who enrolled
Week 0
Retention Rate
Time Frame: Week 2
Total number of participants who enrolled in the study who remained until completion
Week 2
Adherence Rate
Time Frame: Week 2
Completion of 75% of the planned in-person sessions will be considered adherent; home practice will be tracked via daily logs sent back to study team electronically.
Week 2
Assessment Process Time
Time Frame: Week 2
Amount of time needed for assessments.
Week 2
Acceptability of Intervention Score
Time Frame: Week 2
Overall acceptability of intervention. Target acceptability ratings of at least 4 (agree/completely agree) on a scale of 1 to 5, with a score of 5 being the most acceptable.
Week 2
Client Satisfaction Questionnaire Score
Time Frame: Week 2
Assesses satisfaction with treatment. Scores range from 8 to 32; higher scores indicate more satisfaction.
Week 2
Intervention Usability Scale Score
Time Frame: Week 2
Measures intervention usability. Scores range from 0-100; a score of 70 or greater may be considered adequate.
Week 2
Visual analog scale for pain (VAS) score
Time Frame: Week 1, Week 2
Acute effects using a VAS scale of nausea and psychological distress ranging 0 (none at all) to 100 (as much as there could be) before and after each session to assess immediate relief of symptoms. Higher scores indicate more nausea and psychological distress.
Week 1, Week 2
Semi-Structured Interview
Time Frame: Week 2
30-minute qualitative interview for perspectives on the barriers and facilitators to program engagement and suggestions for improvement, benefits of yoga intervention, and specific questions about format, usability, and burden of the intervention and current and future assessments. Key domains corresponding to the research goals will be developed based on the interview guide. All responses within each domain will be summarized to identify key findings which will be used to inform adaptation of the intervention.
Week 2
Semi-Structured Interview
Time Frame: Week 3
30-minute qualitative interview for perspectives on the barriers and facilitators to program engagement and suggestions for improvement, benefits of yoga intervention, and specific questions about format, usability, and burden of the intervention and current and future assessments. Key domains corresponding to the research goals will be developed based on the interview guide. All responses within each domain will be summarized to identify key findings which will be used to inform adaptation of the intervention.
Week 3
Semi-Structured Interview
Time Frame: Week 4
30-minute qualitative interview for perspectives on the barriers and facilitators to program engagement and suggestions for improvement, benefits of yoga intervention, and specific questions about format, usability, and burden of the intervention and current and future assessments. Key domains corresponding to the research goals will be developed based on the interview guide. All responses within each domain will be summarized to identify key findings which will be used to inform adaptation of the intervention.
Week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wake Forest University Health Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Elyse Thakur, MD, Wake Forest University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 18, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 3, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 3, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 10, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 10, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 13, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 28, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 24, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB00122246
  • 400983697 (Other Identifier: American Neurogastroenterology and Motility Society)

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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