IBS - Irritable Bowel SyndromeNCT04946604
Ashtangayoga for IBS Show Positive Preliminary Effects on Symptoms and Well-being
A study testing Ashtangayoga in people with IBS - Irritable Bowel Syndrome, run by Karolinska Institutet at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- IBS - Irritable Bowel Syndrome
- What is being tested?
- Ashtangayoga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteSweden
- Study dates
- 18 Jan 2018to 30 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- IBS diagnosis
Who cannot join
- Prior yoga practise, unable to speak Swedish, other serious illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- IBS - Irritable Bowel Syndrome
- Being tested
- Ashtangayoga
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AshtangayogaBehavioural
This is an active and intense type of yoga, focused on physical activity and breath control
| Study group | Role | What they receive |
|---|---|---|
| Ashtangayoga | Other | Participants attanded eight yoga sessions, one hour long. Receives: Behavioral: Ashtangayoga |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)
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.
Measured: Pre (0 weeks), post (after 10 weeks), follow-up (after 22 weeks)
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
Measured: Pre (0 weeks), post (after 10 weeks), follow-up (after 22 weeks)
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.
Measured: Pre (0 weeks), post (after 10 weeks), follow-up (after 22 weeks)
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.
Measured: Pre (0 weeks), post (after 10 weeks), follow-up (after 22 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2021
- Study start18 Jan 2018
- Primary completion30 Oct 2019
- Study completion30 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IBS - Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Each participant is given the intervention, and they are measured at pre, post and 6 month follow-up.
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Praktikertjänst AB (Ltd)
- Responsible party
- Principal investigator, Perjohan Lindfors, Karolinska Institutet
- Investigators
- Perhjohan Lindfors, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04946604
- Sponsor's protocol ID
- 751-17
- Status last verified
- Jun 2021
- First submitted
- 8 Jun 2021
- Last updated
- 1 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ashtangayoga for IBS Show Positive Preliminary Effects on Symptoms and Well-being in an Uncontrolled Pilot Study
- ClinicalTrials.gov ID
- NCT04946604
- Acronym / sponsor ID
- 751-17
- Conditions
- IBS - Irritable Bowel Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Praktikertjänst AB (Ltd)
- Study start
- 18 Jan 2018 (actual)
- Primary completion
- 30 Oct 2019 (actual)
- Study completion
- 30 Oct 2019 (actual)
- First posted
- 1 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Each participant is given the intervention, and they are measured at pre, post and 6 month follow-up.
| Arm | Type | Receives |
|---|---|---|
| Ashtangayoga | Other | Behavioral: AshtangayogaParticipants attanded eight yoga sessions, one hour long. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- IBS diagnosis
Key exclusion criteria (1 listed)
- Prior yoga practise, unable to speak Swedish, other serious illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AshtangayogaThis is an active and intense type of yoga, focused on physical activity and breath control | Behavioural | Ashtangayoga |
Primary outcome
Change in Irritable Bowel Syndrome Severity Scoring System (IBS-SSS)
Time frame: Change from pre-treatment (baseline) to post-treatment (week 10), change from post-treatment (week 10) to follow-up (week 22)
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)
Time frame: Change from pre-treatment (baseline) to post-treatment (week 10), change from post-treatment (week 10) to follow-up (week 22)
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.
4 secondary outcomes
IBS Quality of Life (IBSQOL)
Time frame: Pre (0 weeks), post (after 10 weeks), follow-up (after 22 weeks)
Visceral Sensitivity Index (VSI)
Time frame: Pre (0 weeks), post (after 10 weeks), follow-up (after 22 weeks)
Hospital Anxiety and Depression Scale (HADS)
Time frame: Pre (0 weeks), post (after 10 weeks), follow-up (after 22 weeks)
The Patient Health Questionnaire 12 (PHQ-12)
Time frame: Pre (0 weeks), post (after 10 weeks), follow-up (after 22 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2021.
- Individual participant dataSharing planned: No
Related trials for IBS - Irritable Bowel Syndrome
RecruitingObservational study
Abdominal Symptoms and Rosacea: An Observational Study on the Association Between Irritable Bowel Syndrome (IBS) and the Gut-Skin Axis
IBS (Irritable Bowel Syndrome), Rosacea
Recruiting
Stress Reduction and Lifestyle Modification in Irritable Bowel Syndrome Patients
Irritable Bowel Syndrome
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)
Irritable Bowel Syndrome, Diarrhea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Perhjohan Lindfors, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ashtangayoga in people with IBS - Irritable Bowel Syndrome, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Irritable Bowel Syndrome Severity Scoring System (IBS-SSS) (time frame: Change from pre-treatment (baseline) to post-treatment (week 10), change from post-treatment (week 10) to follow-up (week 22)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2021.