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NCT Number: NCT06211400

Vibration Exercise for Crohn's to Observe Response

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.

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Key information

Conditions

Crohn's Disease Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Hertfordshire

Hatfield, UK, AL10 9EU, United Kingdom

Location status: Recruiting

Location contact

Lindsay Bottoms

CONTACT

[email protected]

+441707285685

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Primary outcomes

  1. Inflammatory Bowel Disease Questionnaire (IBDQ)

    Time frame: 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 outcomes

  1. Crohn's disease activity index (CDAI)

    Time frame: 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

  2. Concentration of Faecal Calprotectin (FC)

    Time frame: change in FC from baseline to 6 weeks

    a marker of inflammation in the gastrointestinal tract. Higher levels are indicative of higher inflammation levels

  3. Inflammatory Bowel Disease Fatigue (IBD Fatigue)

    Time frame: 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.

  4. Hospital Anxiety and Depression (HADS)

    Time frame: 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.

  5. Perceived pain

    Time frame: 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

  6. Estimated Cardiorespiratory fitness

    Time frame: 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.

  7. Concentration of Tnf-alpha

    Time frame: change from baseline to 6 weeks

    This measure will be obtained from blood samples to provide a measure of inflammation

  8. Concentration of Interleukin-6 (IL6)

    Time frame: change from baseline to 6 weeks

    This measure will be obtained from blood samples to provide a measure of inflammation

  9. Concentration of Interleuken-10 (IL10)

    Time frame: change from baseline to 6 weeks

    This measure will be obtained from blood samples to provide a measure of inflammation

  10. Concentration of Interleukin 17a (IL17a)

    Time frame: change from baseline to 6 weeks

    This measure will be obtained from blood samples to provide a measure of inflammation

  11. Concentration of Interleukin 12 (IL12)

    Time frame: change from baseline to 6 weeks

    This measure will be obtained from blood samples to provide a measure of inflammation

  12. Concentration of Interleukin 23 (IL23)

    Time frame: change from baseline to 6 weeks

    This measure will be obtained from blood samples to provide a measure of inflammation

  13. Concentration of Transforming Growth Factor Beta (TGF-Beta)

    Time frame: change from baseline to 6 weeks

    This measure will be obtained from blood samples to provide a measure of inflammation

Study contacts

Contact information is provided by the study sponsor or research team.

Lindsay Bottoms

CONTACT

[email protected]

+441707285685

Sponsors and collaborators

Lead sponsor

University of Hertfordshire

Other

Collaborators

  • Anglia Ruskin University
  • University of Central Lancashire

Registry information

Acronym: VECTOR

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Jan 18, 2024
Registry last updated
Jul 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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