Vibration Exercise for Crohn's to Observe Response

Crohn's Disease Clinical Trial

— VECTOR  

Official title:

Vibration Exercise for Crohn's to Observe Response

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06211400
• Other study ID #: VECTOR
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2024
• Est. completion date: January 1, 2028

Study information

• Verified date: June 2024
• Source: University of Hertfordshire
• Contact: Lindsay Bottoms
• Phone: +441707285685
• Email: l.bottoms[@]herts.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 168
• Est. completion date: January 1, 2028
• Est. primary completion date: July 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of Hertfordshire	Anglia Ruskin University, University of Central Lancashire

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Concentration of Tnf-alpha	This measure will be obtained from blood samples to provide a measure of inflammation	change from baseline to 6 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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