Crohns Disease Inflammatory bowel disease Ulcerative Colitis
Conditions
Interventions
None listed
Sponsors
Universiteit Maastricht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria for all participants: - 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 Physical Activity Readiness Questionnaire); - Being able to provide written informed consent; - Willing and being able to complete questionnaires and perform performance tests; - Being able to understand written Dutch and speak the Dutch language. Inclusion criteria specific for patients with IBD: - Certified diagnosis of IBD (UC or CD) based on the combination of endoscopic, radiological, and/or histological findings; - No clinical active disease or experiencing mild to moderate clinical disease activity (Harvey-Bradshaw Index [HBI]
Exclusion criteria
Exclusion criteria: Exclusion criteria for all participants: - ASA Physical Status > II (i.e., patient with severe systemic disease); - Contraindications for exercise testing based on the Physical Activity Readiness Questionnaire; If a person answers *yes* to one or more questions, a medical doctor will be consulted to see whether the person should participate or be excluded on safety grounds; - Other (temporary) injuries or severe (neuro)muscular, rheumatic, or orthopedic conditions that may interfere with study evaluations; - Current malignancy (except for local cutaneous cancer) or successfully treated for a malignancy in the past 6 months; - Pregnant or lactating women; - Competitive and elite athletes (i.e., >=6 hours/week of moderate to vigorous exercise); - Not being able to cooperate with test procedures or unable to provide informed consent; - Not being able to understand or speak the Dutch language.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameters are the results of the screening tools (Duke Activity Status Index, Modified Duke Activity Status Index, Veterans-Specific Activity Questionnaire, Fitmax Questionnaire), of the tests of the assessment battery (skinfold thickness, bioelectrical impedance analysis, upper arm and waist circumference, steep ramp test, handgrip strength and endurance, handheld dynamometry of the leg extensor and flexor muscles, 1-minute sit-to-stand test, and sit-and-reach test), and of the gold standard measures for HRPF (deuterium oxide dilution, maximal cardiopulmonary exercise testing, and Biodex dynamometry of the leg extensor and flexor muscles). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints include: - Subjective physical activity expressed in estimated metabolic equivalents (MET) min/week derived from the International Physical Activity Questionnaire - Short Form (IPAQ-SF) - Total physical activity measured with the MOX accelerometer; - Fatigue scores according to the Checklist Individual Strength (CIS) - Patient perspectives on physical fitness, on the relationship between physical fitness and IBD-related complaints, and their willingness to improve physical fitness according to the *Lichamelijke Fitheid Vragenlijst* Other study parameters include: - Patient characteristics: age, gender, comorbidities, socio-economic status, IBD-subtype, clinical features of IBD (e.g., disease activity scores [according to fecal calprotectin, PGA, MIAH, CDAI, HBI, or SCCAI], Montreal classification, disease duration, complications, extra-intestinal manifestations), (IBD-related) surgical history, (IBD-related) hospitalization, medication use, smoking status; - Other relevant patient-reported information collected for usual care in myIBDcoach, including: disease control according to the IBD-control questionnaire, quality of life according to the ED-5Q-5L questionnaire, infections, exercise norm, risk of malnutrition according to the SNAQ, stress and life events, anxiety according to the GAD-7 questionnaire, and depression according to the PHQ-9 questionnaire (30). | — |
Countries
Netherlands
Outcome results
None listed