Vibration Exercise for Crohn's to Observe Response

Not Applicable

Recruiting

• Conditions: Crohn's Disease

• Registration Number: NCT06211400
• Lead Sponsor: University of Hertfordshire

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-08
• Study First Submitted QC: 2024-01-08
• Study First Posted: 2024-01-18
• Study Start: 2025-03-31
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-17
• Last Update Posted: 2025-07-18
• Primary Completion: 2027-07-01
• Study Completion: 2028-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 168

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
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
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
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 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
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 Interleukin 23 (IL23)	change from baseline to 6 weeks	This measure will be obtained from blood samples to provide a measure of inflammation

Trial Locations

Locations (1)

University of Hertfordshire; 🇬🇧 Hatfield, UK, United Kingdom