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

Ulcerative Colitis Clinical Trial

— OPTIMIZE-UC  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05743153
• Other study ID #: 114110
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: October 1, 2024

Study information

• Verified date: January 2023
• Source: Radboud University Medical Center
• Contact: Dorien Oomkens
• Phone: +31650084590
• Email: dorien.oomkens[@]radboudumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: October 1, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years old;

• Diagnosis of UC confirmed by clinical, endoscopic, and/or histological evidence prior to screening as per standard criteria;

• Ability of subject to participate fully in all aspects of this project;

• Written informed consent must be obtained and documented.

Exclusion Criteria:

• Suspicion of differential diagnosis of CD, indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease associated with colitis, or microscopic colitis;

• Serious underlying disease other than UC that in the opinion of the investigator may interfere with the subject's ability to participate fully in the study or would compromise subject safety (such as history of malignancies, major neurological disorders, certain orthopedic impairments or any unstable, uncontrolled or severe systemic medical disorder);

• History of alcohol or drug abuse that in the opinion of the investigator may interfere with the subject's ability to comply with the study procedures;

• History of psychiatric disorders that in the opinion of the investigator may interfere with the subject's ability to comply with the study procedures;

• If female, the subject is pregnant or lactating (< 1 year) or intending to become pregnant;

• Immobilized patients who are not able to complete exercise intervention;

• Illiteracy (disability to read and understand Dutch).

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Dorien Oomkens	Nijmegen

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accrural	The percentage of approached, eligible participants that are included in the study.	24 weeks
Primary	Attrition	The percentage of participants who stopped the program prematurely.	24 weeks
Primary	Adherence to exercise program	Frequency of followed trainings	24 weeks
Primary	Adherence to daily exercise goals	SQUASH questionnaire	24 weeks
Primary	Satisfaction	Measured using a patient satisfaction questionnaire	24 weeks
Primary	Safety	Measured by the number of adverse events occurring during the program	24 weeks
Secondary	Change in Oxygen Consumption (VO2 max)	Indication of physical fitness	1 year
Secondary	Change in 1 repitition measures	Indication of muscle strength	1 year
Secondary	Change in body weight	Measured in kilograms	1 year
Secondary	Change in fat-free mass	Measured with bioelectrical impedance analysis (BIA)	1 year
Secondary	Change in nutritional status	Measured with Patient Generated Subjective Global Assessment (PG-SGA)	1 year
Secondary	Change in mental health	Hospital Anxiety and Depression scale (HADS questionnaire)	1 year
Secondary	Change in Work Productivity and Activity Impairment	Work Productivity and Activity Impairment Questionnaire (including WPAI-GH)	1 year
Secondary	Change in 36-Item Short Form Health Survey (SF-36) score	Quality of life	1 year
Secondary	Change in EuroQoL (EQ-5D-5L) score	Quality of life	1 year
Secondary	Change in Inflammatory Bowel Disease Questionnaire score	Disease-related quality of life	1 year