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

NCT06732453 | Recruiting

• 2 other identifiers: IRB00122246400983697
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Functional Dyspepsia; Gastroparesis

Keywords

Yoga; Disorders of the upper gastrointestinal (GI) tract; Brain-gut behavior

Outcome Measures

Primary Outcomes (12)

• 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

Study Arms (1)

Seated Yoga Intervention

EXPERIMENTAL

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)

Interventions

Seated Yoga Skills Training in Functional Dyspepsia and Gastroparesis (FD-GP) OTHER

Two one-hour chair-based yoga sessions that will include gentle movements, breathing practices, and meditation, along with home practice.

Seated Yoga Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Atrium Health Gastroenterology and Hepatology Kenilworth

Charlotte, North Carolina, 28204, United States

RECRUITING

MeSH Terms

Conditions

Gastroparesis

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Elyse Thakur, MD

  Wake Forest University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica Kearney-Bryan, BSN

CONTACT

704-355-0244; jessica.kearney-bryan@advocatehealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2024
• First Posted: December 13, 2024
• Study Start: June 18, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 23, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)