Vibration Exercise for Crohn's to Observe Response

NCT06211400 | Recruiting

• 1 other identifier: VECTOR
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (13)

• Crohn's disease activity index (CDAI)

  change in CDAI from baseline to 6 weeks

• Concentration of Faecal Calprotectin (FC)

  change in FC from baseline to 6 weeks

• Inflammatory Bowel Disease Fatigue (IBD Fatigue)

  change in IBD fatigue from baseline to 6 weeks

• Hospital Anxiety and Depression (HADS)

  change in HADS from baseline to 6 weeks

• Perceived pain

  change in pain from baseline to 6 weeks

Study Arms (2)

Vibration Exercise

EXPERIMENTAL

Other: Whole body vibration exercise

Control

NO INTERVENTION

Interventions

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

Vibration Exercise

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Hertfordshire: lead
• University of Central Lancashire: collaborator
• Anglia Ruskin University: collaborator

Study Sites (1)

University of Hertfordshire

Hatfield, UK, AL10 9EU, United Kingdom

RECRUITING

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Central Study Contacts

Lindsay Bottoms

CONTACT

+441707285685; l.bottoms@herts.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2024
• First Posted: January 18, 2024
• Study Start: March 31, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: July 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)