The numbers tell the tale: the validation of an assessment battery for health-related physical fitness in patients with inflammatory bowel disease.
- Conditions
- Crohns DiseaseInflammatory bowel diseaseUlcerative Colitis10017969
- Registration Number
- NL-OMON51526
- Lead Sponsor
- niversiteit Maastricht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 300
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] <= 16 for CD and Simple Clinical Colitis
Activity Index [SCCAI] <=11 for UC)
- Included in eHealth clinical care-pathway using myIBDcoach.
Inclusion criteria specific for control subjects:
- No certified diagnosis of IBD (CD, UC or IBD-Unclassified);
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.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main study parameters are the results of the screening tools (Duke Activity<br /><br>Status Index, Modified Duke Activity Status Index, Veterans-Specific Activity<br /><br>Questionnaire, Fitmax Questionnaire), of the tests of the assessment battery<br /><br>(skinfold thickness, bioelectrical impedance analysis, upper arm and waist<br /><br>circumference, steep ramp test, handgrip strength and endurance, handheld<br /><br>dynamometry of the leg extensor and flexor muscles, 1-minute sit-to-stand test,<br /><br>and sit-and-reach test), and of the gold standard measures for HRPF (deuterium<br /><br>oxide dilution, maximal cardiopulmonary exercise testing, and Biodex<br /><br>dynamometry of the leg extensor and flexor muscles). </p><br>
- Secondary Outcome Measures
Name Time Method