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

23. juni 2021 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

14

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Sverige
    • Stockholms Län
      • Stockholm, Stockholms Län, Sverige, 11364
        • Centre for psychatry research

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 65 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • IBS diagnosis

Exclusion Criteria:

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Annen: Ashtangayoga
Participants attanded eight yoga sessions, one hour long.
Atferdsmessig: Ashtangayoga
This is an active and intense type of yoga, focused on physical activity and breath control

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Irritable Bowel Syndrome Severity Scoring System (IBS-SSS)
Tidsramme: 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 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)
Tidsramme: 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.
Change from pre-treatment (baseline) to post-treatment (week 10), change from post-treatment (week 10) to follow-up (week 22)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
IBS Quality of Life (IBSQOL)
Tidsramme: Pre (0 weeks), post (after 10 weeks), follow-up (after 22 weeks)
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.
Pre (0 weeks), post (after 10 weeks), follow-up (after 22 weeks)
Visceral Sensitivity Index (VSI)
Tidsramme: Pre (0 weeks), post (after 10 weeks), follow-up (after 22 weeks)
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
Pre (0 weeks), post (after 10 weeks), follow-up (after 22 weeks)
Hospital Anxiety and Depression Scale (HADS)
Tidsramme: Pre (0 weeks), post (after 10 weeks), follow-up (after 22 weeks)
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.
Pre (0 weeks), post (after 10 weeks), follow-up (after 22 weeks)
The Patient Health Questionnaire 12 (PHQ-12)
Tidsramme: Pre (0 weeks), post (after 10 weeks), follow-up (after 22 weeks)
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.
Pre (0 weeks), post (after 10 weeks), follow-up (after 22 weeks)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Karolinska Institutet

Samarbeidspartnere

Praktikertjänst AB (Ltd)

Etterforskere

  • Hovedetterforsker: Perhjohan Lindfors, PhD, Karolinska Institutet

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

18. januar 2018

Primær fullføring (Faktiske)

30. oktober 2019

Studiet fullført (Faktiske)

30. oktober 2019

Datoer for studieregistrering

Først innsendt

8. juni 2021

Først innsendt som oppfylte QC-kriteriene

23. juni 2021

Først lagt ut (Faktiske)

1. juli 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

1. juli 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

23. juni 2021

Sist bekreftet

1. juni 2021

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 751-17

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

Nei

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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