Vibration exercise for improving symptoms in Crohn's disease
Vibration Exercise for Crohn's to Observe Response
This study is testing if whole body vibration exercise can help adults with mild to moderate Crohn's disease feel better and improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 168 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Hertfordshire Academic / other |
| Locations | 1 site (Hatfield, UK) |
| Trial ID | NCT06211400 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of whole body vibration exercise on individuals with Crohn's disease, a chronic inflammatory condition affecting the digestive system. The aim is to assess whether this low-cost and safe intervention can enhance health-related quality of life (HRQOL) and alleviate symptoms such as abdominal pain and fatigue. Participants will be adults aged 18-65 with mild to moderate active Crohn's disease who engage in minimal physical activity. The study will involve regular exercise sessions and the completion of questionnaires to evaluate outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with a clinical diagnosis of mild to moderate Crohn's disease who engage in less than 60 minutes of purposeful exercise per week.
Not a fit: Patients over 65 years old or those with severe uncontrolled medical conditions or serious autoimmune diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the quality of life for patients with Crohn's disease by reducing symptoms and enhancing overall well-being.
How similar studies have performed: While the specific approach of whole body vibration exercise for Crohn's disease is novel, exercise interventions have shown promise in improving quality of life in similar chronic conditions.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Hatfield, UK
- University of Hertfordshire — Hatfield, UK, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Lindsay Bottoms
- Email: l.bottoms@herts.ac.uk
- Phone: +441707285685
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.