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Recruiting NCT06211400

Vibration Exercise for Crohn's to Observe Response

No phase Interventional Crohn's Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Whole body vibration exercise.
Who it may be relevant to
Registry conditions: Crohn's Disease. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Other 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

Primary outcome measures

  • Inflammatory Bowel Disease Questionnaire (IBDQ) [Time frame: change in IBDQ from baseline to 6 weeks]
Secondary outcome measures (12)
  • Crohn's disease activity index (CDAI) [Time frame: change in CDAI from baseline to 6 weeks]
  • Concentration of Faecal Calprotectin (FC) [Time frame: change in FC from baseline to 6 weeks]
  • Inflammatory Bowel Disease Fatigue (IBD Fatigue) [Time frame: change in IBD fatigue from baseline to 6 weeks]
  • Hospital Anxiety and Depression (HADS) [Time frame: change in HADS from baseline to 6 weeks]
  • Perceived pain [Time frame: change in pain from baseline to 6 weeks]
  • Estimated Cardiorespiratory fitness [Time frame: change in estimated maximal oxygen consumption from baseline to 6 weeks]
  • Concentration of Tnf-alpha [Time frame: change from baseline to 6 weeks]
  • Concentration of Interleukin-6 (IL6) [Time frame: change from baseline to 6 weeks]
  • Concentration of Interleuken-10 (IL10) [Time frame: change from baseline to 6 weeks]
  • Concentration of Interleukin 17a (IL17a) [Time frame: change from baseline to 6 weeks]
  • Concentration of Interleukin 12 (IL12) [Time frame: change from baseline to 6 weeks]
  • Concentration of Interleukin 23 (IL23) [Time frame: change from baseline to 6 weeks]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Other

Study locations

United Kingdom · 1 center
  • University of Hertfordshire — Hatfield

Identifiers

NCT: NCT06211400 · VECTOR

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗