Ulcerative ColitisOPTIMIZE-UCNCT05743153
Feasibility of a Multimodal Intervention Program to Optimize Treatment Outcomes in Ulcerative Colitis
A study testing Multimodal intervention program in people with Ulcerative Colitis, run by Radboud University Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Multimodal intervention program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Mar 2024to 1 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Multimodal intervention program
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal intervention programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with ulcerative colitis | Experimental | Patients participate in multimodal intervention Receives: Behavioral: Multimodal intervention program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accrural
The percentage of approached, eligible participants that are included in the study.
Measured: 24 weeks
Attrition
The percentage of participants who stopped the program prematurely.
Measured: 24 weeks
Adherence to exercise program
Frequency of followed trainings
Measured: 24 weeks
Adherence to daily exercise goals
SQUASH questionnaire
Measured: 24 weeks
Patient satisfaction
Measured using a patient satisfaction questionnaire
Measured: 24 weeks
Safety and adverse events
Measured by the number of adverse events occurring during the program
Measured: 24 weeks
Secondary outcomes (10)
Change in Oxygen Consumption (VO2 max)
Indication of physical fitness
Measured: 1 year
Change in 1 repitition measures
Indication of muscle strength
Measured: 1 year
Change in body weight
Measured in kilograms
Measured: 1 year
Change in fat-free mass
Measured with bioelectrical impedance analysis (BIA)
Measured: 1 year
Change in nutritional status
Measured with Patient Generated Subjective Global Assessment (PG-SGA)
Measured: 1 year
Change in mental health
Hospital Anxiety and Depression scale (HADS questionnaire)
Measured: 1 year
Change in Work Productivity and Activity Impairment
Work Productivity and Activity Impairment Questionnaire (including WPAI-GH)
Measured: 1 year
Change in 36-Item Short Form Health Survey (SF-36) score
Quality of life
Measured: 1 year
Change in EuroQoL (EQ-5D-5L) score
Quality of life
Measured: 1 year
Change in Inflammatory Bowel Disease Questionnaire score
Disease-related quality of life
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2023
- Study start1 Mar 2024
- Primary completion1 Mar 2025
- Study completion1 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05743153
- Sponsor's protocol ID
- 114110
- Acronym
- OPTIMIZE-UC
- Status last verified
- Jan 2023
- First submitted
- 20 Jan 2023
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OPTIMIZE-UC: Feasibility of a Multimodal Intervention Program to Optimize Treatment Outcomes in Ulcerative Colitis: A Prospective Pilot Study
- ClinicalTrials.gov ID
- NCT05743153
- Acronym / sponsor ID
- OPTIMIZE-UC / 114110
- Conditions
- Ulcerative Colitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 24 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with ulcerative colitis | Experimental | Behavioral: Multimodal intervention programPatients participate in multimodal intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multimodal intervention programExercise 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. | Behavioural | Patients with ulcerative colitis |
Primary outcome
Accrural
Time frame: 24 weeks
The percentage of approached, eligible participants that are included in the study.
Attrition
Time frame: 24 weeks
The percentage of participants who stopped the program prematurely.
Adherence to exercise program
Time frame: 24 weeks
Frequency of followed trainings
Adherence to daily exercise goals
Time frame: 24 weeks
SQUASH questionnaire
Patient satisfaction
Time frame: 24 weeks
Measured using a patient satisfaction questionnaire
Safety and adverse events
Time frame: 24 weeks
Measured by the number of adverse events occurring during the program
10 secondary outcomes
Change in Oxygen Consumption (VO2 max)
Time frame: 1 year
Change in 1 repitition measures
Time frame: 1 year
Change in body weight
Time frame: 1 year
Change in fat-free mass
Time frame: 1 year
Change in nutritional status
Time frame: 1 year
Change in mental health
Time frame: 1 year
Change in Work Productivity and Activity Impairment
Time frame: 1 year
Change in 36-Item Short Form Health Survey (SF-36) score
Time frame: 1 year
Change in EuroQoL (EQ-5D-5L) score
Time frame: 1 year
Change in Inflammatory Bowel Disease Questionnaire score
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal intervention program in people with Ulcerative Colitis, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accrural (time frame: 24 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.