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| Name | Class |
|---|---|
| University of Central Lancashire | OTHER |
| Anglia Ruskin University | OTHER |
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Background: Crohn's disease (CD) is a long-term inflammatory condition of the digestive system. People with CD often have unpredictable and debilitating symptoms, including abdominal pain, diarrhoea and fatigue. In addition, they require long-term treatment with frequent negative effects and often need surgery and hospitalisations. Therefore, people with CD report a lower health-related quality of life (HRQOL) compared with other people. Doctors are constantly trying to find new treatments to improve HRQOL and control symptoms and whole body vibration exercise could be a potential treatment.
Exercise might be a simple, safe, and low-cost intervention for improving HRQOL in people with CD. This is because it has the potential to improve several aspects of physical, mental and social well-being simultaneously. Adults with CD have been shown to be less active than the general population and do not meet the recommended daily physical activity guidelines. One barrier to exercise is lack of time, however whole-body vibration exercise (where you stand and squat on a vibrating plate) can be done over a much shorter duration and at a lower intensity to gain potentially similar or at times greater benefits. More research is needed to understand the effects, both positive and negative of vibration exercise in people with CD.
Aim: This study begins to understand whether undertaking a supervised 6-week vibration exercise programme for adults with mild to moderately active Crohn's disease improves HRQoL and other symptoms such as fatigue.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vibration Exercise | Experimental |
| |
| Control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whole body vibration exercise | Other | 6-week supervised whole body vibration exercise programme (training sessions three times per week lasting 10 min) alongside a lifestyle education programme |
| Measure | Description | Time Frame |
|---|---|---|
| Inflammatory Bowel Disease Questionnaire (IBDQ) | The scale has 32 items scored on a 7-point Likert scale, ranging from 1 (worst health) to 7 (best health). | change in IBDQ from baseline to 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Crohn's disease activity index (CDAI) | CDAI is a clinically assessed measure of disease activity in Crohn's patients. The score ranges from 0-600 with higher scores being indicative of higher disease activity | change in CDAI from baseline to 6 weeks |
| Concentration of Faecal Calprotectin (FC) |
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Inclusion Criteria:
Aged over 18-65 years old
Clinical diagnosis of CD for at least 4 weeks before randomization
Exclusion Criteria:
Over 65 years old Severe or uncontrolled medical conditions that make it undesirable for the patient to participate
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lindsay Bottoms | Contact | +441707285685 | l.bottoms@herts.ac.uk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Hertfordshire | Recruiting | Hatfield | UK | AL10 9EU | United Kingdom |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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a marker of inflammation in the gastrointestinal tract. Higher levels are indicative of higher inflammation levels |
| change in FC from baseline to 6 weeks |
| Inflammatory Bowel Disease Fatigue (IBD Fatigue) | The IBD Fatigue Scale is comprised of two components. Part 1 the questionnaire will identify fatigue, its severity, frequency and duration and scores range from 0-20 with a higher score meaning greater fatigue. Part 2 assesses the perceived impact of fatigue on your daily activities and scores range from 0-120 with a higher score meaning greater perceived impact. | change in IBD fatigue from baseline to 6 weeks |
| Hospital Anxiety and Depression (HADS) | The Hospital Anxiety and Depression Scale measures anxiety and depression in patients. A higher score indicates greater anxiety and depression. | change in HADS from baseline to 6 weeks |
| Perceived pain | visual analogue scale from 0-10, 0 being no pain and 10 being most intense pain possible | change in pain from baseline to 6 weeks |
| Estimated Cardiorespiratory fitness | Chester step test to estimate maximal oxygen consumption. It involves stepping in time to a metronome and measuring heart rate. | change in estimated maximal oxygen consumption from baseline to 6 weeks |
| Concentration of Tnf-alpha | This measure will be obtained from blood samples to provide a measure of inflammation | change from baseline to 6 weeks |
| Concentration of Interleukin-6 (IL6) | This measure will be obtained from blood samples to provide a measure of inflammation | change from baseline to 6 weeks |
| Concentration of Interleuken-10 (IL10) | This measure will be obtained from blood samples to provide a measure of inflammation | change from baseline to 6 weeks |
| Concentration of Interleukin 17a (IL17a) | This measure will be obtained from blood samples to provide a measure of inflammation | change from baseline to 6 weeks |
| Concentration of Interleukin 12 (IL12) | This measure will be obtained from blood samples to provide a measure of inflammation | change from baseline to 6 weeks |
| Concentration of Interleukin 23 (IL23) | This measure will be obtained from blood samples to provide a measure of inflammation | change from baseline to 6 weeks |
| Concentration of Transforming Growth Factor Beta (TGF-Beta) | This measure will be obtained from blood samples to provide a measure of inflammation | change from baseline to 6 weeks |
| D007410 | Intestinal Diseases |