Primary Objective: To assess the feasibility of a multimodal intervention program for patients UC. Secondary Objectives: To investigate the effects of a multimodal intervention program on: - An individual patient*s level, i.e. physical fitness (…
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
- Autoimmune disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
This study assesses the feasibility and optimal timing of a multimodal
intervention program.
Feasibility is assessed by:
- Accrural
- Attrition
- Adherence to the program
- Satisfaction
- Safety
Secondary outcome
To investigate the effects of a multimodal intervention program on:
o An individual patient*s level, i.e. physical fitness (estimated VO2 peak,
indirect 1 repetition measures, physical activity), nutritional status (body
weight, fat-free mass, Patient-Generated Subjective Global Assessment
(PG-SGA)), mental health (HADS), quality of life (IBDQ, SF-36, EQ-5D-5L) and
Work Productivity and Activity Impairment (questionnaire in Appendix IV).
o Therapy outcomes: e.g. number and severity of (S)AEs, corticosteroid use,
biochemical and clinical response/remission rates and patient reported outcomes.
Background summary
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. Intervention
programs in preparation for 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 patients with active disease 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 active UC, as well as UC in remission, is
of high relevance.
Study objective
Primary Objective: To assess the feasibility of a multimodal intervention
program for patients UC.
Secondary Objectives: To investigate the effects of a multimodal intervention
program on:
- An individual patient*s level, i.e. physical fitness (estimated VO2 peak,
indirect 1 repetition measures, physical activity), nutritional status (body
weight, fat-free mass, Patient-Generated Subjective Global Assessment
(PG-SGA)), mental health (HADS), quality of life (IBDQ, SF-36, EQ-5D-5L) and
Work Productivity and Activity Impairment (questionnaire in Appendix IV).
- Therapy outcomes: e.g. number and severity of (S)AEs, corticosteroid use,
biochemical and clinical response/remission rates and patient reported
outcomes.
Study design
This is a feasibility study. Participants will receive standard care and
follow-up, but will on top of that participate in the multimodal intervention
program.
Intervention
Patients will participate in a multimodal intervention program including an
exercise program, nutritional intervention and psychological support if
screened at risk using a screening questionnaire.
Study burden and risks
It is very likely that patients will benefit from partaking in this program, as
they will be working on their physical, mental and nutritional health. No
minors and incapacitated subjects will be included. Participating in this trial
will not delay standard care in any way. Exercise is not expected to cause risk
to patients. The amount of tests might be perceived as a burden for patients.
Geert Groteplein Zuid 10
Nijmegen 6525GA
NL
Geert Groteplein Zuid 10
Nijmegen 6525GA
NL
Listed location countries
Age
Inclusion criteria
o Age >= 18 years old;
o Diagnosis of Ulcerative Colitis confirmed by clinical, endoscopic, and/or
histological evidence prior to screening as per standard criteria;
o Written informed consent must be obtained and documented.
Exclusion criteria
o Suspicion of differential diagnosis of Crohn's Disease, indeterminate
colitis, ischemic colitis, radiation colitis, diverticular disease associated
with colitis, or microscopic colitis;
o 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);
o If female, the subject is pregnant or lactating (< 1 year) or intending to
become pregnant;
o Immobilized patients who are not able to complete exercise intervention;
o Illiteracy (disability to read and understand Dutch).
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT05743153 |
| CCMO | NL83603.091.23 |