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

Not Applicable

Not yet recruiting

• Conditions: Functional Dyspepsia; Gastroparesis

• Registration Number: NCT06732453
• Lead Sponsor: Wake Forest University Health Sciences

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).

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 Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-12-10
• Study First Submitted QC: 2024-12-10
• Study First Posted: 2024-12-13
• Last Update Submitted: 2025-04-25
• Last Update Posted: 2025-04-27
• Study Start: 2025-05
• Primary Completion: 2026-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Screening Rate	Week 0	Tracking the number of screened participants, those who are eligible, and the percent who agree to participate.
Recruitment Rate	Week 0	Total number of patients who enrolled and proportion of patients eligible who enrolled
Retention Rate	Week 2	Total number of participants who enrolled in the study who remained until completion
Adherence Rate	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.
Assessment Process Time	Week 2	Amount of time needed for assessments.
Acceptability of Intervention Score	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.
Client Satisfaction Questionnaire Score	Week 2	Assesses satisfaction with treatment. Scores range from 8 to 32; higher scores indicate more satisfaction.
Intervention Usability Scale Score	Week 2	Measures intervention usability. Scores range from 0-100; a score of 70 or greater may be considered adequate.
Visual analog scale for pain (VAS) score	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.
Semi-Structured Interview	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.

Trial Locations

Locations (1)

Atrium Health Gastroenterology and Hepatology Kenilworth; 🇺🇸 Charlotte, North Carolina, United States