Clinical trial NCT06211400: Vibration Exercise for Crohn's to Observe Response
Official title: Vibration Exercise for Crohn's to Observe Response
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Crohn's Disease
Lead sponsor: University of Hertfordshire
Sponsor class: OTHER
Collaborators: name: University of Central Lancashire
name: Anglia Ruskin University
First posted: 2024-01-18
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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)

Primary outcomes:
measure: Inflammatory Bowel Disease Questionnaire (IBDQ)
timeFrame: change in IBDQ from baseline to 6 weeks
Secondary outcomes:
measure: Crohn's disease activity index (CDAI)
timeFrame: change in CDAI from baseline to 6 weeks
measure: Concentration of Faecal Calprotectin (FC)
timeFrame: change in FC from baseline to 6 weeks
measure: Inflammatory Bowel Disease Fatigue (IBD Fatigue)
timeFrame: change in IBD fatigue from baseline to 6 weeks
measure: Hospital Anxiety and Depression (HADS)
timeFrame: change in HADS from baseline to 6 weeks
measure: Perceived pain
timeFrame: change in pain from baseline to 6 weeks
measure: Estimated Cardiorespiratory fitness
timeFrame: change in estimated maximal oxygen consumption from baseline to 6 weeks
measure: Concentration of Tnf-alpha
timeFrame: change from baseline to 6 weeks
measure: Concentration of Interleukin-6 (IL6)
timeFrame: change from baseline to 6 weeks
measure: Concentration of Interleuken-10 (IL10)
timeFrame: change from baseline to 6 weeks
measure: Concentration of Interleukin 17a (IL17a)
timeFrame: change from baseline to 6 weeks
measure: Concentration of Interleukin 12 (IL12)
timeFrame: change from baseline to 6 weeks
measure: Concentration of Interleukin 23 (IL23)
timeFrame: change from baseline to 6 weeks
measure: Concentration of Transforming Growth Factor Beta (TGF-Beta)
timeFrame: change from baseline to 6 weeks
Other outcomes:
Locations:
city: Hatfield
country: United Kingdom
facility: University of Hertfordshire
state: UK
Study officials:
References: