Clinical trial NCT05482932: Health-related Physical Fitness in Patients with Inflammatory Bowel Disease
Official title: The Numbers Tell the Tale: the Validation of an Assessment Battery for Health-related Physical Fitness in Patients with Inflammatory Bowel Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammatory Bowel Diseases
Ulcerative Colitis
Crohn Disease
Keywords: Inflammatory bowel disease
Ulcerative Colitis
Crohn Disease
Health-related physical fitness
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Dutch Gastroenterology & Hepatology Foundation (Maag Lever Darm Stichting)
First posted: 2022-08-01
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: 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.

Eligibility 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 PAR-Q
* Being able to provide written informed consent;
* Willing and 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 active disease or experiencing mild to moderate disease activity.
* Included in eHealth clinical care-pathway using myIBDcoach.

Inclusion criteria specific for healthy volunteers:

• No certified diagnosis of IBD (CD, UC, IBD-Unclassified);

Exclusion criteria for all participants:

* ASA Physical Status \> II (i.e., patient with severe systemic disease);
* Contraindications for exercise testing based on PAR-Q
* Other (temporary) injuries or severe (neuro)muscular, rheumatic, or orthopedic conditions that may interfere with study evaluations;
* Current malignancy (except for local cutaneous skin 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 understand or speak the Dutch language;
* Not being able to cooperate with test procedures or unable to provide informed consent.

Primary outcomes:
measure: Duke Activity Status Index
timeFrame: Study visit 1, at time of inclusion (cross sectional study design)
measure: Veterans-Specific Activity Questionnaire
timeFrame: Study visit 1, at time of inclusion (cross sectional study design)
measure: Sum of 4 skinfold thicknessess
timeFrame: Study visit 1, at time of inclusion (cross sectional study design)
measure: Bioelectrical impedance analysis
timeFrame: Study visit 1, at time of inclusion (cross sectional study design)
measure: Mid upper arm circumference
timeFrame: Study visit 1, at time of inclusion (cross sectional study design)
measure: Waist circumference
timeFrame: Study visit 1, at time of inclusion (cross sectional study design)
measure: Steep ramp test (peak work rate)
timeFrame: Study visit 1, at time of inclusion (cross sectional study design)
measure: Handgrip strength
timeFrame: Study visit 1, at time of inclusion (cross sectional study design)
measure: Handgrip endurance
timeFrame: Study visit 1, at time of inclusion (cross sectional study design)
measure: Handheld dynamometry
timeFrame: Study visit 1, at time of inclusion (cross sectional study design)
measure: 1 minute sit-to-stand test
timeFrame: Study visit 1, at time of inclusion (cross sectional study design)
measure: sit-and-reach test
timeFrame: Study visit 1, at time of inclusion (cross sectional study design)
measure: Deuterium oxide dilution (Only applicable for first 50 included patients with IBD)
timeFrame: Study visit 2, 7 to 14 days after inclusion (cross sectional study design)
measure: Cardiopulmonary exercise test (Only applicable for first 50 included patients with IBD)
timeFrame: Study visit 2, 7 to 14 days after inclusion (cross sectional study design)
measure: Biodex 4 Pro dynamometry (Only applicable for first 50 included patients with IBD)
timeFrame: Study visit 2, 7 to 14 days after inclusion (cross sectional study design)
Secondary outcomes:
measure: International Physical Activity Questionnaire
timeFrame: Study visit 1, at time of inclusion (cross sectional study design)
measure: Total physical activity measured with accelerometer (Only applicable for first 50 included patients with IBD)
timeFrame: 7 days (between 1st and 2nd study visit)
measure: Checklist Individual Strength
timeFrame: Study visit 1, at time of inclusion (cross sectional study design)
Other outcomes:
measure: Patient characteristics
timeFrame: At time of inclusion (cross sectional study design)
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center +
state: Limburg
Study officials:
affiliation: Maastricht University Medical Center
name: M.J. Pierik, Prof.
role: PRINCIPAL_INVESTIGATOR
References: