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The primary aim of the project is to investigate whether a behavioural training programme improves troublesome bowel symptoms, that people with inflammatory bowel disease continue to have, despite their disease being controlled by medication. The other aim is to determine if there are factors which influence how well the training programme works.
People attending an Inflammatory Bowel Disease clinic in a tertiary hospital, with bothersome bowel symptoms despite disease control, will be asked to join the study. This involves 2 to 6 sessions with a pelvic floor trained physiotherapist over a period of 6 months with further follow up at 12 months..
Inflammatory bowel diseases, chiefly Crohn's disease and ulcerative colitis, are chronic gastrointestinal (gut) conditions which tend to flare up some times and be quiet for other periods of time. They are usually controlled by medication. Inflammatory bowel disease is becoming more common, is usually diagnosed at a young age and is lifelong.
A significant number of people with inflammatory bowel disease can have bowel symptoms which are bothersome even when the disease is quiescent. These symptoms include bowel urgency, frequent toileting, incontinence (leakage), constipation (infrequent bowel actions and/or difficulty emptying the bowel), abdominal pain, rectal pain or abdominal bloating. The symptoms can be very embarrassing or stressful, limiting activities and making life less enjoyable.
People with these bowel symptoms, but without inflammatory bowel disease, respond to a type of therapy called behavioural treatment. We don't know yet if this treatment helps people with inflammatory bowel disease.
Behavioural treatment involves learning about how the bowel works, better ways to manage bowel problems and specific exercises to improve bowel control. Specially trained pelvic floor physiotherapists provide 2-6 sessions, over 6 months, of behavioural treatment which may include the use of biofeedback techniques.
Participants will be asked to complete surveys at the beginning and end of treatment and 12 months later.
There are no recognised risks or unwanted side effects caused by behavioural treatment. The benefits are that people with inflammatory bowel disease will have an alternative low cost, low risk treatment which enables them to self-manage bowel symptoms and improve the quality of their life long term.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Behavioural treatment | Experimental | 2 to 6 sessions of bowel behavioural training with a pelvic floor physiotherapist |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioural treatment | Behavioral | 2 to 6 sessions of behavioural training with a pelvic floor physiotherapist |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient rating of improvement in symptoms | Proportion of patients achieving a rating of 'moderately improved' or 'substantially improved' on a 7 point Likert scale ranging from 'substantially worse' to 'substantially improved' | At study completion, up to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Personal assessment of Constipation Symptoms (PAC-SYM) score | 12 constipation symptoms each rated on a 5 point Likert scale (0=symptom absent to 4 = very severe. | From baseline to study completion (up to 12 weeks) and at 1 year |
| Change in St Marks Faecal Incontinence Score |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mayo Score | Disease activity index for ulcerative colitis | From baseline to study completion (up to 12 weeks) and at 1 year |
| Change in Harvey Bradshaw Index | Disease activity index for Crohn's disease |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael A Kamm, MBBS PhD | St Vincent's Hospital Melbourne | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Vincent's Hospital | Fitzroy | Victoria | 3065 | Australia |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005767 | Gastrointestinal Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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Prospective cohort
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All assessments are conducted by an assessor not providing the intervention
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Faecal incontinence symptom score ranging from 0-24 |
| From baseline to study completion (up to 12 weeks) and at 1 year |
| Change in Inflammatory Bowel disease questionnaire (IBDQ) score | Disease specific quality of life instrument with 32 questions covering 4 domains - bowel symptoms, systemic symptoms, emotional function, social function | From baseline to study completion (up to 12 weeks) and at 1 year |
| Change in Short Form -36 (SF-36) score | Generic quality of life score | From baseline to study completion (up to 12 weeks) and at 1 year |
| Change in Hospital Anxiety and Depression Score (HADS) | 14 item questionnaire indicating presence of anxiety or depression | From baseline to study completion (up to 12 weeks) and at 1 year |
| Change in Brief Illness Perception Questionnaire score | 9 item questionnaire designed to assess cognitive and emotional perception of illness | From baseline to study completion (up to 12 weeks) and at 1 year |
| Change in Brief Cope score | 28 item questionnaire assessing patients' strategies for coping with stress | From baseline to study completion (up to 12 weeks) and at 1 year |
| Change in Inflammatory Bowel Disease Self-efficacy scale (IBD-SES) | Disease specific scale with 29 items assessing how well patients believe they are managing their disease | From baseline to study completion (up to 12 weeks) and at 1 year |
| Change in Euro-Qol (EQ-5D) | Generic quality of life tool to calculate quality adjusted life years (QALYs) | From baseline to study completion (up to 12 weeks) and at 1 year |
| From baseline to study completion (up to 12 weeks) and at 1 year |
| Patient rating of satisfaction | 7 point Likert scale rating satisfaction | At study completion , up to 12 weeks |
| Change in pelvic floor muscle function | Measurement of pelvic floor muscle movement using transperineal ultrasound | From baseline to study completion (up to 12 weeks) |