- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07717554
Effect of Virtual Yoga in Diabetic Gastroparesis Patients
The Effect of Virtual Yoga Intervention on Symptom Severity and Quality of Life in Patients With Diabetic Gastroparesis
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: SUBHANKAR CHAKRABORTY, M.D., Ph.D.
- Número de teléfono: 614-293-6255'
- Correo electrónico: Subhankar.chakraborty@osumc.edu
Ubicaciones de estudio
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Ohio
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Columbus, Ohio, Estados Unidos, 43210
- Reclutamiento
- Ohio State University Wexner Medical Center
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Contacto:
- Subhankar Chakraborty, MD, Ph.D.
- Número de teléfono: 614-293-6255'
- Correo electrónico: subhankar.chakraborty@osumc.edu
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: Yoga Group
Participants in this group will start Virtual Yoga sessions after completion of baseline surveys.
The Yoga sessions will last for 12 weeks.
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Participants will complete gentle Yoga exercises led by a trained Yoga Instructor.
Sessions will be conducted over Zoom or Teams.
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Comparador activo: 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.
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Participants will complete gentle Yoga exercises led by a trained Yoga Instructor.
Sessions will be conducted over Zoom or Teams.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Gastroparesis Symptoms
Periodo de tiempo: Comparing symptoms after 3 months of Yoga to that at baseline
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Measured using the Gastroparesis Symptom Questionnaire
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Comparing symptoms after 3 months of Yoga to that at baseline
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Physical and Mental Quality of Life
Periodo de tiempo: From baseline to 3 months after starting virtual Yoga Sessions
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Using SF-12 QOL questionnaire, we will measure the physical and mental QOL of participants at baseline and 3 months after starting Yoga sessions
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From baseline to 3 months after starting virtual Yoga Sessions
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Subhankar CHAKRABORTY, MD, Ph.D., Ohio State University
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
- 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.
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- STUDY20250832
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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