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

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: Recruiting
• Conditions: Functional Dyspepsia; Gastroparesis
• Intervention / Treatment: Other: Seated Yoga Skills Training in Functional Dyspepsia and Gastroparesis (FD-GP)

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: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jessica Kearney-Bryan, BSN; Phone Number: 704-355-0244; Email: jessica.kearney-bryan@advocatehealth.org

Study Locations

• United States
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Recruiting
      • Atrium Health Gastroenterology and Hepatology Kenilworth
      • Contact: Elizabeth Meyer, MPH; Phone Number: 704-667-5324; Email: elizabeth.meyer@atriumhealth.org

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Screening Rate	Tracking the number of screened participants, those who are eligible, and the percent who agree to participate.	Week 0
Recruitment Rate	Total number of patients who enrolled and proportion of patients eligible who enrolled	Week 0
Retention Rate	Total number of participants who enrolled in the study who remained until completion	Week 2
Adherence Rate	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	Amount of time needed for assessments.	Week 2
Acceptability of Intervention Score	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	Assesses satisfaction with treatment. Scores range from 8 to 32; higher scores indicate more satisfaction.	Week 2
Intervention Usability Scale Score	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	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	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	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	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

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Elyse Thakur, MD, Wake Forest University

Study record dates

Study Major Dates

• Study Start (Actual): June 18, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: December 10, 2024
• First Submitted That Met QC Criteria: December 10, 2024
• First Posted (Actual): December 13, 2024

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Yoga; Disorders of the upper gastrointestinal (GI) tract; Brain-gut behavior
• Additional Relevant MeSH Terms: Neurologic Manifestations; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Paralysis; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Gastroparesis
• Other Study ID 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