Effect of Virtual Yoga in Diabetic Gastroparesis Patients
Purpose
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.
Condition
- Diabetic Gastroparesis
Eligibility
- Eligible Ages
- Between 18 Years and 65 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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 Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- 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.
- Primary Purpose
- Supportive Care
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator Yoga Group |
Participants in this group will start Virtual Yoga sessions after completion of baseline surveys. The Yoga sessions will last for 12 weeks. |
|
|
Active Comparator Waitlist group |
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. |
|
Recruiting Locations
Columbus, Ohio 43210
More Details
- Status
- Recruiting
- Sponsor
- Ohio State University
Detailed Description
Diabetic gastroparesis (DGP), a chronic complication of diabetes mellitus, is characterized by delayed gastric emptying without evidence of mechanical obstruction. It results from a complex interplay of factors, including hyperglycemia-induced vagal nerve dysfunction, and impaired gastric motility. DGP predominantly affects individuals with long-standing diabetes, particularly those with poor glycemic control or diabetic neuropathy . The condition presents with a constellation of symptoms, including nausea, vomiting, bloating, early satiety and abdominal pain, which significantly impair quality of life . Beyond its physiological burden, DGP often leads to psychological distress, mental well-being, anxiety, depression, and sleep disorders. Conventional management of DGP encompasses dietary modifications, pharmacological treatments, and invasive interventions. Small, frequent meals and low-fat, low-fiber diets are often recommended to minimize symptom severity. Pharmacological therapies, such as prokinetic agents (e.g., metoclopramide, domperidone) and antiemetics, provide symptomatic relief but are limited by side effects and inconsistent efficacy. In refractory cases, interventions like gastric electrical stimulation may be employed. Despite these measures, most patients experience incomplete relief, highlighting the need for novel, holistic approaches to management. In addition to conventional therapies, complementary and alternative approaches like acupressure, a non-invasive technique, have been explored as a potential intervention for gastroparesis. Studies suggest that acupressure points such as (P6) and (ST36), can improve gastric motility and reduce symptoms like nausea and vomiting by modulating vagal activity and enhancing gastric peristalsis. Yoga, another integrative therapy, has also demonstrated efficacy in addressing gastrointestinal disorders such as irritable bowel syndrome (IBS) and functional dyspepsia. Yoga-based intervention has shown promising results in improving autonomic regulation and managing diabetic neuropathy through yoga. Given its multifaceted benefits, when combined with standard care, yoga-based interventions can significantly enhance autonomic function, improve glycemic control, and reduce the severity of neuropathic symptoms in patients with diabetes mellitus. These findings suggest that yoga may have a beneficial role in managing the symptom severity and quality of life in gastrointestinal complications such as diabetic gastroparesis. In this study, we will evaluate the effect of a virtual yoga module on physical and psychological symptoms and quality of life of patients with diabetic gastroparesis. This study will fill a critical gap in whether an ancient holistic practice like Yoga has any effect on physical and mental health of these patients.