Ashtangayoga for IBS Show Positive Preliminary Effects on Symptoms and Well-being
Primary Purpose
IBS - Irritable Bowel Syndrome
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Ashtangayoga
Sponsored by
About this trial
This is an interventional treatment trial for IBS - Irritable Bowel Syndrome
Eligibility Criteria
Inclusion Criteria:
- IBS diagnosis
Exclusion Criteria:
- Prior yoga practise, unable to speak Swedish, other serious illness
Sites / Locations
- Centre for psychatry research
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Ashtangayoga
Arm Description
Participants attanded eight yoga sessions, one hour long.
Outcomes
Primary Outcome Measures
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 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.
Secondary Outcome Measures
IBS Quality of Life (IBSQOL)
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.
Visceral Sensitivity Index (VSI)
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
Hospital Anxiety and Depression Scale (HADS)
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.
The Patient Health Questionnaire 12 (PHQ-12)
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.
Full Information
NCT ID
NCT04946604
First Posted
June 8, 2021
Last Updated
June 23, 2021
Sponsor
Karolinska Institutet
Collaborators
Praktikertjänst AB (Ltd)
1. Study Identification
Unique Protocol Identification Number
NCT04946604
Brief Title
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
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
January 18, 2018 (Actual)
Primary Completion Date
October 30, 2019 (Actual)
Study Completion Date
October 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
Praktikertjänst AB (Ltd)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IBS - Irritable Bowel Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Each participant is given the intervention, and they are measured at pre, post and 6 month follow-up.
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ashtangayoga
Arm Type
Other
Arm Description
Participants attanded eight yoga sessions, one hour long.
Intervention Type
Behavioral
Intervention Name(s)
Ashtangayoga
Intervention Description
This is an active and intense type of yoga, focused on physical activity and breath control
Primary Outcome Measure Information:
Title
Change in Irritable Bowel Syndrome Severity Scoring System (IBS-SSS)
Description
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.
Time Frame
Change from pre-treatment (baseline) to post-treatment (week 10), change from post-treatment (week 10) to follow-up (week 22)
Title
Change in Gastrointestinal Symptom Rating Scale - IBS version (GSRS-IBS)
Description
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.
Time Frame
Change from pre-treatment (baseline) to post-treatment (week 10), change from post-treatment (week 10) to follow-up (week 22)
Secondary Outcome Measure Information:
Title
IBS Quality of Life (IBSQOL)
Description
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.
Time Frame
Pre (0 weeks), post (after 10 weeks), follow-up (after 22 weeks)
Title
Visceral Sensitivity Index (VSI)
Description
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
Time Frame
Pre (0 weeks), post (after 10 weeks), follow-up (after 22 weeks)
Title
Hospital Anxiety and Depression Scale (HADS)
Description
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.
Time Frame
Pre (0 weeks), post (after 10 weeks), follow-up (after 22 weeks)
Title
The Patient Health Questionnaire 12 (PHQ-12)
Description
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.
Time Frame
Pre (0 weeks), post (after 10 weeks), follow-up (after 22 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
IBS diagnosis
Exclusion Criteria:
Prior yoga practise, unable to speak Swedish, other serious illness
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Perhjohan Lindfors, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for psychatry research
City
Stockholm
State/Province
Stockholms Län
ZIP/Postal Code
11364
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
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Ashtangayoga for IBS Show Positive Preliminary Effects on Symptoms and Well-being
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