NCT05482932Completed
Health-related Physical Fitness in Patients with Inflammatory Bowel Disease
The Numbers Tell the Tale: the Validation of an Assessment Battery for Health-related Physical Fitness in Patients with Inflammatory Bowel Disease
Source: ClinicalTrials.gov · Last updated 17 Dec 2024
Brief summary (registry, in English)
Rationale: Existing literature suggests an impaired health-related physical fitness (HRPF) (i.e., body composition, aerobic capacity, muscular strength, muscular endurance, and flexibility) in patients with inflammatory bowel disease (IBD). However, previous studies did not assess HRPF with the 5- component multidimensional concept. HRPF is not routinely screened for and measured within the IBD population in clinical practice. The lack of a simple screening tool and assessment method for HRPF validated for the IBD population hinders the ability to distinguish patients with IBD with adequate physical fitness from those who might benefit from physical exercise interventions targeting specific components. Gold standard measures are too expensive and too complex to implement in daily practice and therefore a screening tool and a simpler assessment battery for HRPF validated in patients with IBD are needed. It is necessary to obtain more objective insights into the specific components of HRPF affected in patients with IBD, and its association with patient-, disease-, and treatment-related factors in order to implement systematic screening in routine care and subsequently offer tailored physical exercise interventions. Objective: The main objective of this study is to validate a simple screening tool and a best-practice assessment battery for the different components of HRPF against gold standard measures. Secondary objectives are to objectively assess the incidence of specific components affected in patients with IBD compared to healthy control subjects and to explore the association between these components of HRPF affected and patient-, disease-, and treatment-related factors.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 200 (actual)
- First submitted
- 19 Jul 2022
- Start date
- 17 Aug 2022
- Primary completion date
- 27 Sept 2024
- Lead sponsor
- Maastricht University Medical Center
- Diseases
- Crohn's disease, Ulcerative colitis
- NCT number
- NCT05482932
What you commit to
- Study type: Observational
- Participants enrolled: 200
- From 17 Aug 2022 to the primary completion date, 27 Sept 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- ASA Physical Status \> II (i.e., patient with severe systemic disease);
- Other (temporary) injuries or severe (neuro)muscular, rheumatic, or orthopedic conditions that may interfere with study evaluations;
- Current malignancy (except for local cutaneous skin cancer) or successfully treated for a malignancy in the past 6 months;
Other
- Contraindications for exercise testing based on PAR-Q
- Pregnant or lactating women;
- Competitive and elite athletes (i.e., ≥6 hours/week of moderate to vigorous exercise)
- Not being able to understand or speak the Dutch language;
- Not being able to cooperate with test procedures or unable to provide informed consent.
Who the study is looking for
- Any gender aged 18 years or older;
- American Society of Anesthesiologists (ASA) Physical Status I or II (i.e., normal healthy patient or a patient with mild systemic disease)
- No contraindications for exercise testing based on the PAR-Q
- Being able to provide written informed consent;
- Willing and able to complete questionnaires and perform performance tests;
- Being able to understand written Dutch and speak the Dutch language.
- Certified diagnosis of IBD (UC or CD) based on the combination of endoscopic, radiological, and/or histological findings;
- No active disease or experiencing mild to moderate disease activity.
- Included in eHealth clinical care-pathway using myIBDcoach.
- No certified diagnosis of IBD (CD, UC, IBD-Unclassified);
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Maastricht University Medical Center Coordinator of this site? Confirm its status | Maastricht | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.