Ashtangayoga for IBS Show Positive Preliminary Effects on Symptoms and Well-being
23 juin 2021 mis à jour par: Perjohan Lindfors, Karolinska Institutet
Ashtangayoga for IBS Show Positive Preliminary Effects on Symptoms and Well-being in an Uncontrolled Pilot Study
The study aims to test the effect of Ashtanga yoga on well-being in patients with irritable bowel syndrome (IBS).
The intervention comprises group sessions on the Ashtanga school of yoga.
Participants are recruited from primary care and measurements on well-being and IBS symptoms are conducted at pre-treatment, post-treatment and 6-month follow-up.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
The intervention comprises participants with IBS to undergo Ashtanga yoga sessions in a group led by an authorized yoga teacher for a total period of 10 weeks.
The first 4 weeks consisted of 1 session/week and the following 6 weeks consisted of 1 session/2 weeks.
All movements and exercises are performed based on the individual's personal capacity in order to avoid distinct discomfort or pain.
Patients testing positive for IBS will be recruited for the study from primary care.
Measurements of IBS symptoms, visceral sensitivity, extraintestinal symptoms and quality of life will be assessed at pre-treatment, post-treatment and 6-month follow-up.
Specific statistical methods will be performed to assess changes from pre- to post-treatments and changes from post-treatment to 6-month-follow-up.
Effects sizes for within group changes will also be calculated.
Type d'étude
Interventionnel
Inscription (Réel)
14
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Stockholms Län
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Stockholm, Stockholms Län, Suède, 11364
- Centre for psychatry research
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 65 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- IBS diagnosis
Exclusion Criteria:
- Prior yoga practise, unable to speak Swedish, other serious illness
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Autre: Ashtangayoga
Participants attanded eight yoga sessions, one hour long.
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This is an active and intense type of yoga, focused on physical activity and breath control
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in Irritable Bowel Syndrome Severity Scoring System (IBS-SSS)
Délai: Change from pre-treatment (baseline) to post-treatment (week 10), change from post-treatment (week 10) to follow-up (week 22)
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Irritable Bowel Syndrome Severity Scoring System (IBS-SSS; [17] is a scale that measure the global severity of IBS-symptoms.
It includes five items; pain severity, pain frequency, bowel bloating, bowel habit dissatisfaction and life interference that are scored on a visual analogue scale (VAS) 0-100 mm.
The total score ranges from 0-500 with higher scores indicating more severe symptoms.
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Change from pre-treatment (baseline) to post-treatment (week 10), change from post-treatment (week 10) to follow-up (week 22)
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Change in Gastrointestinal Symptom Rating Scale - IBS version (GSRS-IBS)
Délai: Change from pre-treatment (baseline) to post-treatment (week 10), change from post-treatment (week 10) to follow-up (week 22)
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Gastrointestinal Symptom Rating Scale - IBS version (GSRS-IBS; [18] measures the severity of IBS-symptoms experienced over the past week.
The scale consists of 13 items measuring five symptom domains of IBS: satiety, pain, diarrhea, constipation and bloating.
The symptoms are rated on a scale ranging from 1 (= no discomfort) to 7 (= very severe discomfort) with a total score from 13-91.
Higher scores indicating more severe symptoms.
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Change from pre-treatment (baseline) to post-treatment (week 10), change from post-treatment (week 10) to follow-up (week 22)
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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IBS Quality of Life (IBSQOL)
Délai: Pre (0 weeks), post (after 10 weeks), follow-up (after 22 weeks)
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IBS Quality of Life (IBSQOL; [19] is a disease-specific health-related quality of life scale (HRQOL).
The instrument consists of 34 items that measure nine domains of quality of life: emotional functioning, mental health, physical functioning, sleep, diet, energy, social role, physical role and sexual relations.
Each item is rated on a scale from 1 to 5 or 1 to 6, the raw scores is then transformed into a scale of 0-100 with higher scores indicating a better IBS-specific quality of life.
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Pre (0 weeks), post (after 10 weeks), follow-up (after 22 weeks)
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Visceral Sensitivity Index (VSI)
Délai: Pre (0 weeks), post (after 10 weeks), follow-up (after 22 weeks)
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Visceral Sensitivity Index (VSI; [20] measures gastrointestinal symptom-specific anxiety.
The scale consists of 15 items rated on a scale from 0 (=strongly agree) to 5 (=strongly disagree).
The total score ranges from 0-75 with higher scores suggesting higher GI-related anxiety
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Pre (0 weeks), post (after 10 weeks), follow-up (after 22 weeks)
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Hospital Anxiety and Depression Scale (HADS)
Délai: Pre (0 weeks), post (after 10 weeks), follow-up (after 22 weeks)
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Hospital Anxiety and Depression Scale (HADS; [21] measures the severity of anxiety and depression in non-psychiatric patients.
It consists of 14 items, seven related to anxiety and seven to depression.
Each item is scored from 0-3 which gives a total range of 0-21 points.
Higher scores indicate more severe symptoms.
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Pre (0 weeks), post (after 10 weeks), follow-up (after 22 weeks)
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The Patient Health Questionnaire 12 (PHQ-12)
Délai: Pre (0 weeks), post (after 10 weeks), follow-up (after 22 weeks)
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The Patient Health Questionnaire 12 (PHQ-12; [22] is a modification of PHQ-15 which measures the experience of 15 different somatic symptoms.
Three of the 15 items are GI-related and are therefore excluded from the PHQ-12 in order to be able to exclusively measure extraintestinal somatic symptoms.
The symptoms measured are back pain, chest pain, dizziness, fainting spells, feeling the heart pound or race, headaches, pain in arms or legs, pain during sexual intercourse, shortness of breath, tiredness, trouble sleeping and problems with the period.
The questionnaire consists of 12 items rated on a scale from 0 (=not bothered at all) to 2 (=bothered a lot).
The total score ranges from 0-24, higher scores indicate greater extraintestinal symptoms.
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Pre (0 weeks), post (after 10 weeks), follow-up (after 22 weeks)
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Perhjohan Lindfors, PhD, Karolinska Institutet
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
18 janvier 2018
Achèvement primaire (Réel)
30 octobre 2019
Achèvement de l'étude (Réel)
30 octobre 2019
Dates d'inscription aux études
Première soumission
8 juin 2021
Première soumission répondant aux critères de contrôle qualité
23 juin 2021
Première publication (Réel)
1 juillet 2021
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
1 juillet 2021
Dernière mise à jour soumise répondant aux critères de contrôle qualité
23 juin 2021
Dernière vérification
1 juin 2021
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 751-17
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Non
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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