NCT06211400 Vibration Exercise for Crohn's to Observe Response
| NCT ID | NCT06211400 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Hertfordshire |
| Condition | Crohn's Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 168 participants |
| Start Date | 2025-03-31 |
| Primary Completion | 2027-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 168 participants in total. It began in 2025-03-31 with a primary completion date of 2027-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06211400 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Crohn's Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06211400 currently recruiting?
Yes, NCT06211400 is actively recruiting participants. Contact the research team at l.bottoms@herts.ac.uk for enrollment information.
Where is the NCT06211400 trial being conducted?
This trial is being conducted at Hatfield, United Kingdom.
Who is sponsoring the NCT06211400 clinical trial?
NCT06211400 is sponsored by University of Hertfordshire. The trial plans to enroll 168 participants.
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