Vibration Exercise for Crohn's to Observe Response

NCT ID: NCT06211400

Last Updated: 2025-07-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 168 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-31
• Study Completion Date: 2028-01-01

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.

Conditions

Crohn's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Vibration Exercise

Group Type: EXPERIMENTAL

Whole body vibration exercise

Intervention Type: OTHER

6-week supervised whole body vibration exercise programme (training sessions three times per week lasting 10 min) alongside a lifestyle education programme

Control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Whole body vibration exercise

6-week supervised whole body vibration exercise programme (training sessions three times per week lasting 10 min) alongside a lifestyle education programme

Intervention Type: OTHER

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Central Lancashire

OTHER

Sponsor Role: collaborator

Anglia Ruskin University

OTHER

Sponsor Role: collaborator

University of Hertfordshire

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Hertfordshire

Hatfield, UK, United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Lindsay Bottoms

Role: CONTACT

l.bottoms@herts.ac.uk

+441707285685

Facility Contacts

Lindsay Bottoms

Role: primary

l.bottoms@herts.ac.uk

+441707285685

Other Identifiers

VECTOR

Identifier Type: -

Identifier Source: org_study_id