NCT05743153

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 20, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 24, 2023

Completed
7 months until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

September 11, 2023

Status Verified

January 1, 2023

Enrollment Period

1 year

First QC Date

January 20, 2023

Last Update Submit

September 7, 2023

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (10)

  • Change in Oxygen Consumption (VO2 max)

    1 year

  • Change in 1 repitition measures

    1 year

  • Change in body weight

    1 year

  • Change in fat-free mass

    1 year

  • Change in nutritional status

    1 year

  • +5 more secondary outcomes

Study Arms (1)

Patients with ulcerative colitis

EXPERIMENTAL

Patients participate in multimodal intervention

Behavioral: Multimodal intervention program

Interventions

Multimodal intervention programBEHAVIORAL

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.

Patients with ulcerative colitis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dorien Oomkens

Nijmegen, 6525GA, Netherlands

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal Diseases

Central Study Contacts

Dorien Oomkens

CONTACT

+31650084590dorien.oomkens@radboudumc.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2023

First Posted

February 24, 2023

Study Start

October 1, 2023

Primary Completion

October 1, 2024

Study Completion

October 1, 2024

Last Updated

September 11, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)