NCT05743153

Feasibility of a Multimodal Intervention Program to Optimize Treatment Outcomes in Ulcerative Colitis

OPTIMIZE-UC: Feasibility of a Multimodal Intervention Program to Optimize Treatment Outcomes in Ulcerative Colitis: A Prospective Pilot Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, interventional pilot study to assess the feasibility and optimal timing of a multimodal intervention program in Ulcerative Colitis (UC) patients with active disease as well as in patients in remission. Secondly, to demonstrate the effects of a multimodal intervention program on individual patients level and therapy outcomes.

Detailed description

Rationale: Despite considerable advances in the knowledge of UC, and a variation of treatment options, UC still impacts patients' ability to lead a normal life. Clearly, there is an unmet need to improve treatment outcomes. Prehabilitation programs in surgery have shown that the amount of complications is closely related to preoperative physical fitness, nutritional status and psychological well-being. IBD patients often search for self-management strategies to manage their symptoms, however, research focussing on a multimodal intervention approach in parallel to starting new IBD treatment is lacking. Given the potential benefits of intervention programs, limitations of current treatments in terms of improving quality of life and patients' desire for self-management options, we believe that exploring the results of a multimodal intervention program in patients with UC is of high relevance. Objective/study design: This is a prospective, interventional pilot study to assess the feasibility and optimal timing of a multimodal intervention program in UC patients. Secondly, to demonstrate the effects of a multimodal intervention program on individual patients level and therapy outcomes. Study population: Patients ≥ 18 years old, with UC. Intervention: Multimodal intervention program including an exercise program, nutritional intervention and psychological evaluation. Main study parameters/endpoints: This study assesses the feasibility of a multimodal intervention program. Secondary, assesses the effect on: * Individual patients' level, i.e. physical fitness, nutritional status, mental health, quality of life and work productivity and activity impairment. * Therapy outcomes, e.g. adherence, number and severity of (S)AEs, corticosteroid use, biochemical and clinical response/remission rates and patient reported outcomes.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
BEHAVIORAL	Multimodal intervention program	Exercise intervention: combined endurance and resistance training three times a week using workout video's which patients can do at home. Advice to exercise at low-intensity for at least 30 minutes per day. Nutritional intervention: Patients are advised to aim for optimal energy and protein intake (by registered dietician) and to avoid red meat, processed foods and sweetened drinks. Aiming for a mainly plant based diet. Psychological intervention: screening for psychological risk factors and if present, patients are referred to a psychologist for psychological support.

Timeline

• Start date: 2023-10-01
• Primary completion: 2024-10-01
• Completion: 2024-10-01
• First posted: 2023-02-24
• Last updated: 2023-09-11

Locations

1 site across 1 country: Netherlands