Vibration Exercise for Crohn's to Observe Response

Обзор

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.

Вмешательства

• Другое 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

Первичные конечные точки

• Inflammatory Bowel Disease Questionnaire (IBDQ) [Срок оценки: change in IBDQ from baseline to 6 weeks]

Вторичные конечные точки (12)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Другое

Центры проведения

Великобритания · 1 центр

• University of Hertfordshire — Hatfield

Идентификаторы

NCT: NCT06211400 · VECTOR

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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