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Completed

NCT Number: NCT06732453

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

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).

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Key information

Conditions

Functional Dyspepsia Digestive System Diseases Gastrointestinal Diseases Gastroparesis Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomach Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Atrium Health Gastroenterology and Hepatology Kenilworth

Charlotte, North Carolina, 28204, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Screening Rate

    Time frame: Week 0

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

  2. Recruitment Rate

    Time frame: Week 0

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

  3. Retention Rate

    Time frame: Week 2

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

  4. 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.

  5. Assessment Process Time

    Time frame: Week 2

    Amount of time needed for assessments.

  6. 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.

  7. Client Satisfaction Questionnaire Score

    Time frame: Week 2

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

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

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

Acronym: FD-GP

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 13, 2024
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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