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NCT07717554

Overview

NCT ID: NCT07717554
Lead Sponsor: Ohio State UniversityOTHER
Official Title: The Effect of Virtual Yoga Intervention on Symptom Severity and Quality of Life in Patients With Diabetic Gastroparesis
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:

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.

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.

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

Status and Timeline

Status: Recruiting
Last Update Posted: Jul 21, 2026Actual
Start Date: Jul 17, 2026Actual
Primary Completion Date: Jul 16, 2028Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

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

Exclusion Criteria:

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.

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 240Estimated
Primary Purpose: Supportive Care
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Contacts and Locations

Central Contacts: SUBHANKAR CHAKRABORTY, M.D., Ph.D.Contact
Subhankar.chakraborty@osumc.edu

Similar Studies

Participant Group/Arms

Yoga GroupActive 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 groupActive 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