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CompletedNCT06732453FD-GPUpdated Jul 28, 2026

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

An interventional study of Seated Yoga Skills Training in Functional Dyspepsia and Gastroparesis (FD-GP) in Functional Dyspepsia and Gastroparesis, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-28.

Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Functional Dyspepsia
  • Gastroparesis

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Keywords

  • Yoga
  • Disorders of the upper gastrointestinal (GI) tract
  • Brain-gut behavior
03

In context

Gastroparesis

307 studies on the registry are indexed under Gastroparesis; 68 are open to participants now.

This study's enrollment of 10 is below the median of 44 across 202 interventional studies indexed under Gastroparesis.

Browse Gastroparesis studies →

Lead sponsor

Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.

Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • 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)

Interventions

  • OtherSeated 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.

06

What researchers measure

Primary outcomes

  1. Screening Rate

    Tracking the number of screened participants, those who are eligible, and the percent who agree to participate.

    Time frame: Week 0

  2. Recruitment Rate

    Total number of patients who enrolled and proportion of patients eligible who enrolled

    Time frame: Week 0

  3. Retention Rate

    Total number of participants who enrolled in the study who remained until completion

    Time frame: Week 2

  4. 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.

    Time frame: Week 2

  5. Assessment Process Time

    Amount of time needed for assessments.

    Time frame: Week 2

  6. 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.

    Time frame: Week 2

  7. Client Satisfaction Questionnaire Score

    Assesses satisfaction with treatment. Scores range from 8 to 32; higher scores indicate more satisfaction.

    Time frame: Week 2

  8. Intervention Usability Scale Score

    Measures intervention usability. Scores range from 0-100; a score of 70 or greater may be considered adequate.

    Time frame: Week 2

  9. 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.

    Time frame: Week 1, Week 2

  10. 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.

    Time frame: Week 2

  11. 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.

    Time frame: Week 3

  12. 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.

    Time frame: Week 4

07

Study locations

1 site
  • Atrium Health Gastroenterology and Hepatology Kenilworth
    Charlotte, North Carolina 28204, United States
08

References and documents

Study documents

  • Informed consent form · Dec 15, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06732453
Lead sponsor
Wake Forest University Health Sciences
Responsible party
Sponsor
First posted
Dec 13, 2024
Start date
Jun 18, 2025
Primary completion
Jun 3, 2026
Completion
Jun 3, 2026
Last update
Jul 28, 2026

Study contacts

Elyse Thakur, MD
principal investigator · Wake Forest University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.

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