Vibration Exercise for Crohn's to Observe Response (VECTOR)

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 Overview

• Status: Recruiting
• Conditions: Crohn's Disease
• Intervention / Treatment: Other: Whole body vibration exercise

• Study Type: Interventional
• Enrollment (Estimated): 168
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lindsay Bottoms; Phone Number: +441707285685; Email: l.bottoms@herts.ac.uk

Study Locations

• United Kingdom
  • UK
    • Hatfield, UK, United Kingdom, AL10 9EU
      • Recruiting
      • University of Hertfordshire
      • Contact: Lindsay Bottoms; Phone Number: +441707285685; Email: l.bottoms@herts.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Experimental: Vibration Exercise	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	change in IBDQ from baseline to 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	change in CDAI 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.	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.	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	change in pain 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	change in FC 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.	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	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	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	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	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	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	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	change from baseline to 6 weeks

Collaborators and Investigators

• Sponsor: University of Hertfordshire
• Collaborators: University of Central Lancashire; Anglia Ruskin University

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: January 8, 2024
• First Submitted That Met QC Criteria: January 8, 2024
• First Posted (Actual): January 18, 2024

Study Record Updates

• Last Update Posted (Actual): July 18, 2025
• Last Update Submitted That Met QC Criteria: July 17, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: VECTOR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No