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.
Study Type
OBSERVATIONAL
Enrollment
200
Participants will complete several questionnaires and perform multiple health-related physical fitness tests
Maastricht University Medical Center +
Maastricht, Limburg, Netherlands
Duke Activity Status Index
Outcome: estimated VO2peak
Time frame: Study visit 1, at time of inclusion (cross sectional study design)
Veterans-Specific Activity Questionnaire
Outcome: estimated METs
Time frame: Study visit 1, at time of inclusion (cross sectional study design)
Sum of 4 skinfold thicknessess
Outcome: % body fat, fat mass, fat free mass
Time frame: Study visit 1, at time of inclusion (cross sectional study design)
Bioelectrical impedance analysis
Outcome: % body fat, fat mass, fat free mass
Time frame: Study visit 1, at time of inclusion (cross sectional study design)
Mid upper arm circumference
Outcome: cm
Time frame: Study visit 1, at time of inclusion (cross sectional study design)
Waist circumference
Outcome: cm
Time frame: Study visit 1, at time of inclusion (cross sectional study design)
Steep ramp test (peak work rate)
Outcome: peak work rate
Time frame: Study visit 1, at time of inclusion (cross sectional study design)
Handgrip strength
Outcome: kg
Time frame: Study visit 1, at time of inclusion (cross sectional study design)
Handgrip endurance
Outcome: seconds to task failure (sec)
Time frame: Study visit 1, at time of inclusion (cross sectional study design)
Handheld dynamometry
Outcome: peak torque
Time frame: Study visit 1, at time of inclusion (cross sectional study design)
1 minute sit-to-stand test
Outcome: repetitions
Time frame: Study visit 1, at time of inclusion (cross sectional study design)
sit-and-reach test
Outcome: cm
Time frame: 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).
Time frame: 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)
Time frame: 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
Time frame: Study visit 2, 7 to 14 days after inclusion (cross sectional study design)
International Physical Activity Questionnaire
Outcome: MET min/week
Time frame: 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)
Outcome: total physical activity, number of steps and intensity, time spent in posture and intensity
Time frame: 7 days (between 1st and 2nd study visit)
Checklist Individual Strength
Outcome: fatigue
Time frame: Study visit 1, at time of inclusion (cross sectional study design)
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