Clinical trial NCT04946604: Ashtangayoga for IBS Show Positive Preliminary Effects on Symptoms and Well-being
Official title: Ashtangayoga for IBS Show Positive Preliminary Effects on Symptoms and Well-being in an Uncontrolled Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: IBS - Irritable Bowel Syndrome
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Praktikertjänst AB (Ltd)
First posted: 2021-07-01
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Each participant is given the intervention, and they are measured at pre, post and 6 month follow-up.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* IBS diagnosis

Exclusion Criteria:

* Prior yoga practise, unable to speak Swedish, other serious illness

Primary outcomes:
measure: Change in Irritable Bowel Syndrome Severity Scoring System (IBS-SSS)
timeFrame: Change from pre-treatment (baseline) to post-treatment (week 10), change from post-treatment (week 10) to follow-up (week 22)
measure: Change in Gastrointestinal Symptom Rating Scale - IBS version (GSRS-IBS)
timeFrame: Change from pre-treatment (baseline) to post-treatment (week 10), change from post-treatment (week 10) to follow-up (week 22)
Secondary outcomes:
measure: IBS Quality of Life (IBSQOL)
timeFrame: Pre (0 weeks), post (after 10 weeks), follow-up (after 22 weeks)
measure: Visceral Sensitivity Index (VSI)
timeFrame: Pre (0 weeks), post (after 10 weeks), follow-up (after 22 weeks)
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Pre (0 weeks), post (after 10 weeks), follow-up (after 22 weeks)
measure: The Patient Health Questionnaire 12 (PHQ-12)
timeFrame: Pre (0 weeks), post (after 10 weeks), follow-up (after 22 weeks)
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Centre for psychatry research
state: Stockholms Län
Study officials:
affiliation: Karolinska Institutet
name: Perhjohan Lindfors, PhD
role: PRINCIPAL_INVESTIGATOR
References: