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| ID | Type | Description | Link |
|---|---|---|---|
| ZP 21-13 | Other Grant/Funding Number | Dutch Gastroenterology & Hepatology Foundation |
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| Name | Class |
|---|---|
| Dutch Gastroenterology & Hepatology Foundation (Maag Lever Darm Stichting) | UNKNOWN |
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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.
The study involves one or two study visits for patients with IBD and only one study visit for healthy volunteers. During the first study visit, all participants (n=200) will perform the tests of the assessment battery for HRPF and complete several questionnaires. A representative subgroup of patients with IBD will undergo the gold standard measurements for HRPF during a second study visit. Furthermore, total physical activity measured by accelerometry will be measured in this subgroup of patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with IBD | 100 patients with IBD; either Ulcerative Colitis (N=50) or Crohns disease (N=50) |
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| Healthy volunteers without IBD | 100 healthy volunteers (without IBD) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Health-related physical fitness assessment | Diagnostic Test | Participants will complete several questionnaires and perform multiple health-related physical fitness tests |
|
| Measure | Description | Time Frame |
|---|---|---|
| Duke Activity Status Index | Outcome: estimated VO2peak | Study visit 1, at time of inclusion (cross sectional study design) |
| Veterans-Specific Activity Questionnaire | Outcome: estimated METs | Study visit 1, at time of inclusion (cross sectional study design) |
| Sum of 4 skinfold thicknessess | Outcome: % body fat, fat mass, fat free mass | Study visit 1, at time of inclusion (cross sectional study design) |
| Bioelectrical impedance analysis | Outcome: % body fat, fat mass, fat free mass | Study visit 1, at time of inclusion (cross sectional study design) |
| Mid upper arm circumference | Outcome: cm | Study visit 1, at time of inclusion (cross sectional study design) |
| Waist circumference | Outcome: cm | Study visit 1, at time of inclusion (cross sectional study design) |
| Steep ramp test (peak work rate) | Outcome: peak work rate | Study visit 1, at time of inclusion (cross sectional study design) |
| Handgrip strength | Outcome: kg |
| Measure | Description | Time Frame |
|---|---|---|
| International Physical Activity Questionnaire | Outcome: MET min/week | Study visit 1, at time of inclusion (cross sectional study design) |
| Total physical activity measured with accelerometer (Only applicable for first 50 included patients with IBD) |
| Measure | Description | Time Frame |
|---|---|---|
| Patient characteristics | e.g., age, gender, medical history, comorbidities, IBD phenotype, disease duration, extra-intestinal manifestation, medication use, tobacco use | At time of inclusion (cross sectional study design) |
Inclusion criteria for all participants:
Inclusion criteria specific for patients with IBD:
Inclusion criteria specific for healthy volunteers:
• No certified diagnosis of IBD (CD, UC, IBD-Unclassified);
Exclusion criteria for all participants:
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Patients with IBD will be recruited at the gastroenterology outpatient clinic of the Maastricht UMC+. Healthy volunteers will be recruited by means of advertisements in publicly accessible sites such as the hospital, university, and social media, as well as via advertisements as posters in the hospital and university.
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| Name | Affiliation | Role |
|---|---|---|
| M.J. Pierik, Prof. | Maastricht University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maastricht University Medical Center + | Maastricht | Limburg | 6200 MD | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41060265 | Derived | Demers K, van den Bergh N, Bongers BC, van Kuijk SMJ, Mujagic Z, Jonkers DMAE, Pierik MJ, Stassen LPS. Health-Related Physical Fitness in Patients With Inflammatory Bowel Disease vs Healthy Control Subjects. Inflamm Bowel Dis. 2025 Dec 1;31(12):3337-3355. doi: 10.1093/ibd/izaf169. |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D003093 | Colitis, Ulcerative |
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| Study visit 1, at time of inclusion (cross sectional study design) |
| Handgrip endurance | Outcome: seconds to task failure (sec) | Study visit 1, at time of inclusion (cross sectional study design) |
| Handheld dynamometry | Outcome: peak torque | Study visit 1, at time of inclusion (cross sectional study design) |
| 1 minute sit-to-stand test | Outcome: repetitions | Study visit 1, at time of inclusion (cross sectional study design) |
| sit-and-reach test | Outcome: cm | Study visit 1, at time of inclusion (cross sectional study design) |
| Deuterium oxide dilution (Only applicable for first 50 included patients with IBD) | Outcome: % body fat, fat mass, fat free mass). | Study visit 2, 7 to 14 days after inclusion (cross sectional study design) |
| Cardiopulmonary exercise test (Only applicable for first 50 included patients with IBD) | Outcome: VO2max/VO2peak) | Study visit 2, 7 to 14 days after inclusion (cross sectional study design) |
| Biodex 4 Pro dynamometry (Only applicable for first 50 included patients with IBD) | Outcome: peak torque | Study visit 2, 7 to 14 days after inclusion (cross sectional study design) |
Outcome: total physical activity, number of steps and intensity, time spent in posture and intensity
| 7 days (between 1st and 2nd study visit) |
| Checklist Individual Strength | Outcome: fatigue | Study visit 1, at time of inclusion (cross sectional study design) |
| D003092 | Colitis |
| D003108 | Colonic Diseases |