Maastricht University Medical Center +
Maastricht, Limburg, 6200 MD, Netherlands
NCT Number: NCT05482932
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.
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Notify Me18 year and older
All sexes
Observational
Maastricht, Limburg, 6200 MD, Netherlands
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for all participants:
Inclusion criteria
specific for patients with IBD:
Inclusion criteria
specific for healthy volunteers:
Exclusion criteria
for all participants:
Participants will complete several questionnaires and perform multiple health-related physical fitness tests
Time frame: Study visit 1, at time of inclusion (cross sectional study design)
Outcome: estimated VO2peak
Time frame: Study visit 1, at time of inclusion (cross sectional study design)
Outcome: estimated METs
Time frame: Study visit 1, at time of inclusion (cross sectional study design)
Outcome: % body fat, fat mass, fat free mass
Time frame: Study visit 1, at time of inclusion (cross sectional study design)
Outcome: % body fat, fat mass, fat free mass
Time frame: Study visit 1, at time of inclusion (cross sectional study design)
Outcome: cm
Time frame: Study visit 1, at time of inclusion (cross sectional study design)
Outcome: cm
Time frame: Study visit 1, at time of inclusion (cross sectional study design)
Outcome: peak work rate
Time frame: Study visit 1, at time of inclusion (cross sectional study design)
Outcome: kg
Time frame: Study visit 1, at time of inclusion (cross sectional study design)
Outcome: seconds to task failure (sec)
Time frame: Study visit 1, at time of inclusion (cross sectional study design)
Outcome: peak torque
Time frame: Study visit 1, at time of inclusion (cross sectional study design)
Outcome: repetitions
Time frame: Study visit 1, at time of inclusion (cross sectional study design)
Outcome: cm
Time frame: Study visit 2, 7 to 14 days after inclusion (cross sectional study design)
Outcome: % body fat, fat mass, fat free mass).
Time frame: Study visit 2, 7 to 14 days after inclusion (cross sectional study design)
Outcome: VO2max/VO2peak)
Time frame: Study visit 2, 7 to 14 days after inclusion (cross sectional study design)
Outcome: peak torque
Time frame: Study visit 1, at time of inclusion (cross sectional study design)
Outcome: MET min/week
Time frame: 7 days (between 1st and 2nd study visit)
Outcome: total physical activity, number of steps and intensity, time spent in posture and intensity
Time frame: Study visit 1, at time of inclusion (cross sectional study design)
Outcome: fatigue
Time frame: At time of inclusion (cross sectional study design)
e.g., age, gender, medical history, comorbidities, IBD phenotype, disease duration, extra-intestinal manifestation, medication use, tobacco use
Maastricht University Medical Center
Other
The Numbers Tell the Tale: the Validation of an Assessment Battery for Health-related Physical Fitness in Patients with Inflammatory Bowel Disease
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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