Vibrational exercise for Crohn's to observe response (VECTOR): Protocol for a randomized controlled trial

Area of Science:

• Gastroenterology and Immunology
• Rehabilitation Medicine
• Clinical Trial Methodology

Background:

• Crohn's disease (CD) is a chronic inflammatory disorder impacting physical and mental health.
• Current pharmaceutical treatments for CD have limitations including side effects and low adherence.
• Whole body vibration (WBV) is a non-invasive technique with potential to address CD symptoms.

Purpose of the Study:

• To investigate the impact of WBV as a non-pharmaceutical intervention for Crohn's disease.
• To evaluate the effectiveness of WBV combined with lifestyle education compared to lifestyle education alone.

Main Methods:

• A 6-week, parallel randomized controlled trial involving 168 participants with CD.
• Participants will be assigned to either WBV plus lifestyle education or lifestyle education only.
• Health-related quality of life, fatigue, anxiety, pain, physical fitness, and biological markers will be assessed.

Main Results:

• The primary outcome is the change in health-related quality of life from baseline to post-intervention.
• Secondary outcomes include changes in fatigue, anxiety, pain, fitness, and inflammatory markers.
• Statistical analysis will use an intention-to-treat approach with linear mixed-effects models.

Conclusions:

• WBV presents a promising non-invasive therapeutic option for managing Crohn's disease.
• This trial will provide crucial data on the efficacy of WBV in improving patient outcomes.
• Findings may support the integration of WBV into standard care for CD management.