Crohn's DiseaseVECTORNCT06211400
Vibration Exercise for Crohn's to Observe Response
A study testing Whole body vibration exercise in people with Crohn's Disease, run by University of Hertfordshire at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- Whole body vibration exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 31 Mar 2025to 1 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
University of Hertfordshire
Hatfield, UK, AL10 9EU
Lindsay Bottoms, +441707285685, l.bottoms@herts.ac.uk
About this study
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
- Being tested
- Whole body vibration exercise
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole body vibration exerciseOther
6-week supervised whole body vibration exercise programme (training sessions three times per week lasting 10 min) alongside a lifestyle education programme
| Study group | Role | What they receive |
|---|---|---|
| Vibration Exercise | Experimental | Not described Receives: Other: Whole body vibration exercise |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: change in IBDQ from baseline to 6 weeks
Secondary outcomes (13)
Crohn's disease activity index (CDAI)
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
Measured: change in CDAI from baseline to 6 weeks
Concentration of Faecal Calprotectin (FC)
a marker of inflammation in the gastrointestinal tract. Higher levels are indicative of higher inflammation levels
Measured: change in FC from baseline to 6 weeks
Inflammatory Bowel Disease Fatigue (IBD Fatigue)
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.
Measured: change in IBD fatigue from baseline to 6 weeks
Hospital Anxiety and Depression (HADS)
The Hospital Anxiety and Depression Scale measures anxiety and depression in patients. A higher score indicates greater anxiety and depression.
Measured: change in HADS from baseline to 6 weeks
Perceived pain
visual analogue scale from 0-10, 0 being no pain and 10 being most intense pain possible
Measured: change in pain from baseline to 6 weeks
Estimated Cardiorespiratory fitness
Chester step test to estimate maximal oxygen consumption. It involves stepping in time to a metronome and measuring heart rate.
Measured: change in estimated maximal oxygen consumption from baseline to 6 weeks
Concentration of Tnf-alpha
This measure will be obtained from blood samples to provide a measure of inflammation
Measured: change from baseline to 6 weeks
Concentration of Interleukin-6 (IL6)
This measure will be obtained from blood samples to provide a measure of inflammation
Measured: change from baseline to 6 weeks
Concentration of Interleuken-10 (IL10)
This measure will be obtained from blood samples to provide a measure of inflammation
Measured: change from baseline to 6 weeks
Concentration of Interleukin 17a (IL17a)
This measure will be obtained from blood samples to provide a measure of inflammation
Measured: change from baseline to 6 weeks
Concentration of Interleukin 12 (IL12)
This measure will be obtained from blood samples to provide a measure of inflammation
Measured: change from baseline to 6 weeks
Concentration of Interleukin 23 (IL23)
This measure will be obtained from blood samples to provide a measure of inflammation
Measured: change from baseline to 6 weeks
Concentration of Transforming Growth Factor Beta (TGF-Beta)
This measure will be obtained from blood samples to provide a measure of inflammation
Measured: change from baseline to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start31 Mar 2025
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Hertfordshire
- Sponsor type
- University, hospital or other
- Collaborators
- University of Central Lancashire, Anglia Ruskin University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06211400
- Sponsor's protocol ID
- VECTOR
- Acronym
- VECTOR
- Status last verified
- Jul 2025
- First submitted
- 8 Jan 2024
- Last updated
- 18 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vibration Exercise for Crohn's to Observe Response
- ClinicalTrials.gov ID
- NCT06211400
- Acronym / sponsor ID
- VECTOR / VECTOR
- Conditions
- Crohn's Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- University of HertfordshireUniversity, hospital or other
- Collaborators
- University of Central Lancashire, Anglia Ruskin University
- Study start
- 31 Mar 2025 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 18 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vibration Exercise | Experimental | Other: Whole body vibration exercise |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged over 18-65 years old
- Clinical diagnosis of CD for at least 4 weeks before randomization
Key exclusion criteria (8 listed)
- Over 65 years old Severe or uncontrolled medical conditions that make it undesirable for the patient to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole body vibration exercise6-week supervised whole body vibration exercise programme (training sessions three times per week lasting 10 min) alongside a lifestyle education programme | Other | Vibration Exercise |
Primary outcome
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).
13 secondary outcomes
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
Concentration of Transforming Growth Factor Beta (TGF-Beta)
Time frame: change from baseline to 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole body vibration exercise in people with Crohn's Disease, run by University of Hertfordshire at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lindsay Bottoms (+441707285685, l.bottoms@herts.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inflammatory Bowel Disease Questionnaire (IBDQ) (time frame: change in IBDQ from baseline to 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2025.