Functional DyspepsiaFD-GPNCT06732453
Brain-Gut Yoga for Functional Dyspepsia and Gastroparesis (FD-GP)
A study testing Seated Yoga Skills Training in Functional Dyspepsia and Gastroparesis (FD-GP) in people with Functional Dyspepsia and Gastroparesis, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Functional Dyspepsia, Gastroparesis
- What is being tested?
- Seated Yoga Skills Training in Functional Dyspepsia and Gastroparesis (FD-GP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jun 2025to 3 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years and older
- Functional Dyspepsia or Gastroparesis (FP or GP) diagnosed by a physician using standard criteria
- Signed, written consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Atrium Health Gastroenterology and Hepatology Kenilworth
Charlotte, North Carolina, 28204
About this study
Official title: 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).
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.
- Conditions
- Functional Dyspepsia, Gastroparesis
- Being tested
- Seated Yoga Skills Training in Functional Dyspepsia and Gastroparesis (FD-GP)
- Keywords
- Yoga, Disorders of the upper gastrointestinal (GI) tract, Brain-gut behavior
- Medical subject headings
- Gastroparesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Seated Yoga Intervention | Experimental | Two one-hour yoga sessions with home practice administered individually by a yoga interventionist in GI clinic Receives: Other: Seated Yoga Skills Training in Functional Dyspepsia and Gastroparesis (FD-GP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Screening Rate
Tracking the number of screened participants, those who are eligible, and the percent who agree to participate.
Measured: Week 0
Recruitment Rate
Total number of patients who enrolled and proportion of patients eligible who enrolled
Measured: Week 0
Retention Rate
Total number of participants who enrolled in the study who remained until completion
Measured: 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.
Measured: Week 2
Assessment Process Time
Amount of time needed for assessments.
Measured: 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.
Measured: Week 2
Client Satisfaction Questionnaire Score
Assesses satisfaction with treatment. Scores range from 8 to 32; higher scores indicate more satisfaction.
Measured: Week 2
Intervention Usability Scale Score
Measures intervention usability. Scores range from 0-100; a score of 70 or greater may be considered adequate.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2024
- Study start18 Jun 2025
- Primary completion3 Jun 2026
- Study completion3 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional DyspepsiaStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elyse Thakur, MD, Principal investigator, Wake Forest University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06732453
- Sponsor's protocol ID
- IRB00122246
- Other IDs
- 400983697
- Acronym
- FD-GP
- Status last verified
- Oct 2025
- First submitted
- 10 Dec 2024
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation of the Yoga Skills Training for Relief of Nausea and Vomiting in Patients With Functional Dyspepsia and Gastroparesis
- ClinicalTrials.gov ID
- NCT06732453
- Acronym / sponsor ID
- FD-GP / IRB00122246
- Conditions
- Functional Dyspepsia, Gastroparesis
- Keywords
- Yoga, Disorders of the upper gastrointestinal (GI) tract, Brain-gut behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 18 Jun 2025 (actual)
- Primary completion
- 3 Jun 2026 (actual)
- Study completion
- 3 Jun 2026 (actual)
- First posted
- 13 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Seated Yoga Intervention | Experimental | Other: Seated Yoga Skills Training in Functional Dyspepsia and Gastroparesis (FD-GP)Two one-hour yoga sessions with home practice administered individually by a yoga interventionist in GI clinic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years and older
- Functional Dyspepsia or Gastroparesis (FP or GP) diagnosed by a physician using standard criteria
- Signed, written consent
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Seated Yoga Intervention |
Primary outcome
Screening Rate
Time frame: Week 0
Tracking the number of screened participants, those who are eligible, and the percent who agree to participate.
Recruitment Rate
Time frame: Week 0
Total number of patients who enrolled and proportion of patients eligible who enrolled
Retention Rate
Time frame: Week 2
Total number of participants who enrolled in the study who remained until completion
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.
Assessment Process Time
Time frame: Week 2
Amount of time needed for assessments.
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.
Client Satisfaction Questionnaire Score
Time frame: Week 2
Assesses satisfaction with treatment. Scores range from 8 to 32; higher scores indicate more satisfaction.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elyse Thakur, MD principal investigator
Wake Forest University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Seated Yoga Skills Training in Functional Dyspepsia and Gastroparesis (FD-GP) in people with Functional Dyspepsia and Gastroparesis, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Screening Rate (time frame: Week 0). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.