Crohn's Disease
Conditions
Brief summary
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.
Interventions
6-week supervised whole body vibration exercise programme (training sessions three times per week lasting 10 min) alongside a lifestyle education programme
Sponsors
University of Central Lancashire
Anglia Ruskin University
University of Hertfordshire
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Aged over 18-65 years old * Clinical diagnosis of CD for at least 4 weeks before randomization * Mild to moderate active CD (150-220 CDAI) * Stable medication for at least 4 weeks before randomization * Able to provide written consent, complete the study questionnaires and travel to the research centre for study assessment visits and exercise sessions * Be doing less than 60 minutes of purposeful exercise per week
Exclusion criteria
* Over 65 years old Severe or uncontrolled medical conditions that make it undesirable for the patient to participate * Coexistent serious autoimmune disease such as rheumatoid arthritis or systemic sclerosis * Planned major surgery within the first 3 months after randomization * Are pregnant, or are planning pregnancy within the first 3 months after randomization * Poor tolerability to venepuncture or lack of adequate venous access for required blood sampling * Current participation in \>60 min/week of purposeful exercise, such as jogging or cycling * Participation in another clinical trial for which concurrent participation is deemed inappropriate * Any orthopaedic implants (hip, knee, spine)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Inflammatory Bowel Disease Questionnaire (IBDQ) | change in IBDQ from baseline to 6 weeks | The scale has 32 items scored on a 7-point Likert scale, ranging from 1 (worst health) to 7 (best health). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Concentration of Faecal Calprotectin (FC) | change in FC from baseline to 6 weeks | a marker of inflammation in the gastrointestinal tract. Higher levels are indicative of higher inflammation levels |
| Inflammatory Bowel Disease Fatigue (IBD Fatigue) | change in IBD fatigue from baseline to 6 weeks | 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. |
| Hospital Anxiety and Depression (HADS) | change in HADS from baseline to 6 weeks | The Hospital Anxiety and Depression Scale measures anxiety and depression in patients. A higher score indicates greater anxiety and depression. |
| Perceived pain | change in pain from baseline to 6 weeks | visual analogue scale from 0-10, 0 being no pain and 10 being most intense pain possible |
| Estimated Cardiorespiratory fitness | change in estimated maximal oxygen consumption from baseline to 6 weeks | Chester step test to estimate maximal oxygen consumption. It involves stepping in time to a metronome and measuring heart rate. |
| Concentration of Tnf-alpha | change from baseline to 6 weeks | This measure will be obtained from blood samples to provide a measure of inflammation |
| Crohn's disease activity index (CDAI) | change in CDAI from baseline to 6 weeks | 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 |
| Concentration of Interleuken-10 (IL10) | change from baseline to 6 weeks | This measure will be obtained from blood samples to provide a measure of inflammation |
| Concentration of Interleukin 17a (IL17a) | change from baseline to 6 weeks | This measure will be obtained from blood samples to provide a measure of inflammation |
| Concentration of Interleukin 12 (IL12) | change from baseline to 6 weeks | This measure will be obtained from blood samples to provide a measure of inflammation |
| Concentration of Interleukin 23 (IL23) | change from baseline to 6 weeks | This measure will be obtained from blood samples to provide a measure of inflammation |
| Concentration of Transforming Growth Factor Beta (TGF-Beta) | change from baseline to 6 weeks | This measure will be obtained from blood samples to provide a measure of inflammation |
| Concentration of Interleukin-6 (IL6) | change from baseline to 6 weeks | This measure will be obtained from blood samples to provide a measure of inflammation |
Countries
United Kingdom
Contacts
Primary ContactLindsay Bottoms
Outcome results
None listed