Effect of Virtual Yoga in Diabetic Gastroparesis Patients
ConditionDiabetic Gastroparesis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorOhio State University
About this trial
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. 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. 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. 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Virtual Yoga
BehavioralParticipants will complete gentle Yoga exercises led by a trained Yoga Instructor. Sessions will be conducted over Zoom or Teams.
Treatment groups
240 Participants
are divided into 2 treatment groupsGroup A: Yoga GroupActive comparator 1 intervention
Group B: Waitlist groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Gastroparesis Symptoms
Measured using the Gastroparesis Symptom Questionnaire
Time frame
Comparing symptoms after 3 months of Yoga to that at baseline2
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
Time frame
From baseline to 3 months after starting virtual Yoga SessionsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov