Ashtangayoga for IBS Show Positive Preliminary Effects on Symptoms and Well-being

NCT04946604 | Completed

• 1 other identifier: 751-17
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

IBS - Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (2)

• Change in Irritable Bowel Syndrome Severity Scoring System (IBS-SSS)

  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.

  Change from pre-treatment (baseline) to post-treatment (week 10), change from post-treatment (week 10) to follow-up (week 22)

• Change in Gastrointestinal Symptom Rating Scale - IBS version (GSRS-IBS)

  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.

  Change from pre-treatment (baseline) to post-treatment (week 10), change from post-treatment (week 10) to follow-up (week 22)

Secondary Outcomes (4)

• IBS Quality of Life (IBSQOL)

  Pre (0 weeks), post (after 10 weeks), follow-up (after 22 weeks)

• Visceral Sensitivity Index (VSI)

  Pre (0 weeks), post (after 10 weeks), follow-up (after 22 weeks)

• Hospital Anxiety and Depression Scale (HADS)

  Pre (0 weeks), post (after 10 weeks), follow-up (after 22 weeks)

• The Patient Health Questionnaire 12 (PHQ-12)

  Pre (0 weeks), post (after 10 weeks), follow-up (after 22 weeks)

Study Arms (1)

Ashtangayoga

OTHER

Participants attanded eight yoga sessions, one hour long.

Behavioral: Ashtangayoga

Interventions

Ashtangayoga BEHAVIORAL

This is an active and intense type of yoga, focused on physical activity and breath control

Ashtangayoga

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• IBS diagnosis

You may not qualify if:

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

Sponsors & Collaborators

• Karolinska Institutet: lead
• Praktikertjänst AB (Ltd): collaborator

Study Sites (1)

Centre for psychatry research

Stockholm, Stockholm County, 11364, Sweden

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Perhjohan Lindfors, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Model Details: Each participant is given the intervention, and they are measured at pre, post and 6 month follow-up.

Study Record Dates

• First Submitted: June 8, 2021
• First Posted: July 1, 2021
• Study Start: January 18, 2018
• Primary Completion: October 30, 2019
• Study Completion: October 30, 2019
• Last Updated: July 1, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)