Effect of Virtual Yoga in Diabetic Gastroparesis Patients

NCT07717554 | Recruiting

• 1 other identifier: STUDY20250832
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the potential benefits of an online yoga module for patients with gastroparesis. Specifically, the study aims to:

1. 1.Evaluate the Impact of Yoga Practices: Examine whether practicing yoga, including pranayama (breathing techniques), mindfulness meditation, and guided relaxation, can help reduce symptoms of gastroparesis, such as nausea, vomiting, bloating, and abdominal pain.
2. 2.Assess Psychological Factors: Determine if the yoga intervention can improve associated psychological factors, including mental well-being, sleep quality, and overall quality of life for individuals with gastroparesis.
3. 3.Provide Evidence-Based Insights: Contribute to the evidence base on the effectiveness of non-pharmacological treatments like yoga in managing gastroparesis, which may offer an additional, accessible management option for patients.

Conditions

Diabetic Gastroparesis

Keywords

yoga; diabetic gastroparesis; virtual yoga; quality of life; gastroparesis symptom severity

Outcome Measures

Primary Outcomes (2)

• Change in Gastroparesis Symptoms

  Measured using the Gastroparesis Symptom Questionnaire

  Comparing symptoms after 3 months of Yoga to that at baseline

• Physical and Mental Quality of Life

  Using SF-12 QOL questionnaire, we will measure the physical and mental QOL of participants at baseline and 3 months after starting Yoga sessions

  From baseline to 3 months after starting virtual Yoga Sessions

Study Arms (2)

Yoga Group

ACTIVE COMPARATOR

Participants in this group will start Virtual Yoga sessions after completion of baseline surveys. The Yoga sessions will last for 12 weeks.

Behavioral: Virtual Yoga

Waitlist group

ACTIVE COMPARATOR

This group will wait for 12 weeks after enrollment to begin virtual Yoga sessions. They will complete the baseline surveys as in Arm 1 and during the waitlist period will continue completing periodic electronic surveys. After the waiting period they will also complete 12 weeks of Virtual Yoga sessions.

Behavioral: Virtual Yoga

Interventions

Virtual Yoga BEHAVIORAL

Participants will complete gentle Yoga exercises led by a trained Yoga Instructor. Sessions will be conducted over Zoom or Teams.

Waitlist group; Yoga Group

Eligibility Criteria

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

You may qualify if:

• History of type 1 or type 2 diabetes Gastroparesis defined by documented delayed gastric emptying, assessed by a 4-hour gastric emptying test showing more than 10% retained food in the stomach after 4 hours. This test must have been performed clinically before study enrolment.
• Experiencing at least moderate Gastroparesis symptoms

You may not qualify if:

• Patients with severe depression or severe anxiety as assessed by screening questionnaire. Patients with Active inflammatory bowel disease. Participants with abdominal surgeries within the last 3 months. Severe Co-morbidities: Presence of severe comorbid conditions (e.g., advanced cardiovascular or respiratory disease) that could interfere with participation in the yoga intervention. Patients who self-report with current Pregnancy and Breastfeeding
• Regular yoga practitioners (more than once a week) in the last 6 months. Undergoing current treatment for any cancer.

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

RECRUITING

Related Publications (3)

• Ye Y, Yin Y, Huh SY, Almansa C, Bennett D, Camilleri M. Epidemiology, Etiology, and Treatment of Gastroparesis: Real-World Evidence From a Large US National Claims Database. Gastroenterology. 2022 Jan;162(1):109-121.e5. doi: 10.1053/j.gastro.2021.09.064. Epub 2021 Oct 6.

  PMID: 34624355 BACKGROUND

• D'Silva A, Marshall DA, Vallance J, Nasser Y, Rajagopalan V, MacKean G, Raman M. Meditation and yoga for irritable bowel syndrome: study protocol for a randomised clinical trial (MY-IBS study). BMJ Open. 2022 May 26;12(5):e059604. doi: 10.1136/bmjopen-2021-059604.

  PMID: 35618329 BACKGROUND

• Kumar R, Dhamija P, Vardhan G, Kant R, Singh Y, Yadav RK, Rudra B, Pathania M. Evaluating Yoga-Based Intervention Versus the American Diabetes Association Exercise Regimen in Conjunction With Standard Care for Autonomic Neuropathy in Diabetes Mellitus: An Exploratory Clinical Trial. Cureus. 2024 May 29;16(5):e61329. doi: 10.7759/cureus.61329. eCollection 2024 May.

  PMID: 38947647 BACKGROUND

Study Officials

• Subhankar CHAKRABORTY, MD, Ph.D.

  Ohio State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

SUBHANKAR CHAKRABORTY, M.D., Ph.D.

CONTACT

614-293-6255'; Subhankar.chakraborty@osumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Eligible participants will be assigned to either a Yoga group that will begin virtual yoga sessions right away or a Wait list group that will wait for 12 weeks (3 months) to begin virtual Yoga sessions.

Study Record Dates

• First Submitted: July 16, 2026
• First Posted: July 21, 2026
• Study Start: July 17, 2026
• Primary Completion (Estimated): July 16, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: July 21, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)