Ohio State University Wexner Medical Center
Columbus, Ohio, 43210, United States
Location status: Recruiting
NCT Number: NCT07717554
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.
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Not applicable
Columbus, Ohio, 43210, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will complete gentle Yoga exercises led by a trained Yoga Instructor. Sessions will be conducted over Zoom or Teams.
Time frame: Comparing symptoms after 3 months of Yoga to that at baseline
Measured using the Gastroparesis Symptom Questionnaire
Time frame: From baseline to 3 months after starting virtual Yoga Sessions
Using SF-12 QOL questionnaire, we will measure the physical and mental QOL of participants at baseline and 3 months after starting Yoga sessions
Contact information is provided by the study sponsor or research team.
Ohio State University
Other
The Effect of Virtual Yoga Intervention on Symptom Severity and Quality of Life in Patients With Diabetic Gastroparesis
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