Feasibility of a Multimodal Intervention Program to Optimize Treatment Outcomes in Ulcerative Colitis (OPTIMIZE-UC)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Behavioral: Multimodal intervention program

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dorien Oomkens; Phone Number: +31650084590; Email: dorien.oomkens@radboudumc.nl

Study Locations

• Netherlands
  • Nijmegen, Netherlands, 6525GA
    • Dorien Oomkens
    • Principal Investigator: Marjolijn Duijvestein, MD PhD
    • Sub-Investigator: Dorien Oomkens, MD
    • Contact: Dorien Oomkens, MD; Phone Number: +31650084590; Email: dorien.oomkens@radboudumc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Patients with ulcerative colitis; Patients participate in multimodal 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accrural	The percentage of approached, eligible participants that are included in the study.	24 weeks
Attrition	The percentage of participants who stopped the program prematurely.	24 weeks
Adherence to exercise program	Frequency of followed trainings	24 weeks
Adherence to daily exercise goals	SQUASH questionnaire	24 weeks
Satisfaction	Measured using a patient satisfaction questionnaire	24 weeks
Safety	Measured by the number of adverse events occurring during the program	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Oxygen Consumption (VO2 max)	Indication of physical fitness	1 year
Change in 1 repitition measures	Indication of muscle strength	1 year
Change in body weight	Measured in kilograms	1 year
Change in fat-free mass	Measured with bioelectrical impedance analysis (BIA)	1 year
Change in nutritional status	Measured with Patient Generated Subjective Global Assessment (PG-SGA)	1 year
Change in mental health	Hospital Anxiety and Depression scale (HADS questionnaire)	1 year
Change in Work Productivity and Activity Impairment	Work Productivity and Activity Impairment Questionnaire (including WPAI-GH)	1 year
Change in 36-Item Short Form Health Survey (SF-36) score	Quality of life	1 year
Change in EuroQoL (EQ-5D-5L) score	Quality of life	1 year
Change in Inflammatory Bowel Disease Questionnaire score	Disease-related quality of life	1 year

Collaborators and Investigators

• Sponsor: Radboud University Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2023
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: January 20, 2023
• First Submitted That Met QC Criteria: February 14, 2023
• First Posted (Actual): February 24, 2023

Study Record Updates

• Last Update Posted (Actual): September 11, 2023
• Last Update Submitted That Met QC Criteria: September 7, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: 114110

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No