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Effect of Virtual Yoga in Diabetic Gastroparesis Patients

16 juli 2026 uppdaterad av: Ohio State University

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:

  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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

240

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Stödjande vård
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: Yoga Group
Participants in this group will start Virtual Yoga sessions after completion of baseline surveys. The Yoga sessions will last for 12 weeks.
Participants will complete gentle Yoga exercises led by a trained Yoga Instructor. Sessions will be conducted over Zoom or Teams.
Aktiv komparator: 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.
Participants will complete gentle Yoga exercises led by a trained Yoga Instructor. Sessions will be conducted over Zoom or Teams.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Gastroparesis Symptoms
Tidsram: Comparing symptoms after 3 months of Yoga to that at baseline
Measured using the Gastroparesis Symptom Questionnaire
Comparing symptoms after 3 months of Yoga to that at baseline
Physical and Mental Quality of Life
Tidsram: 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
From baseline to 3 months after starting virtual Yoga Sessions

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: Subhankar CHAKRABORTY, MD, Ph.D., Ohio State University

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

17 juli 2026

Primärt slutförande (Beräknad)

16 juli 2028

Avslutad studie (Beräknad)

31 december 2028

Studieregistreringsdatum

Först inskickad

16 juli 2026

Först inskickad som uppfyllde QC-kriterierna

16 juli 2026

Första postat (Faktisk)

21 juli 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

21 juli 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

16 juli 2026

Senast verifierad

1 juli 2026

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • STUDY20250832

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

Due to privacy concerns, we cannot share individual level patient data with other researchers.

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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