Health-related Physical Fitness in Patients With Inflammatory Bowel Disease

Ulcerative Colitis Clinical Trial

Official title:

The Numbers Tell the Tale: the Validation of an Assessment Battery for Health-related Physical Fitness in Patients With Inflammatory Bowel Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05482932
• Other study ID #: NL79305.068.22
• Secondary ID: ZP 21-13
• Status: Not yet recruiting
• Start date: August 1, 2022
• Est. completion date: April 1, 2024

Study information

• Verified date: July 2022
• Source: Maastricht University Medical Center
• Contact: K. Demers, Drs.
• Phone: +31(0)43-3882134
• Email: karlijn.demers[@]mumc.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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=300) 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: April 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Crohn Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Ulcer
• Ulcerative Colitis

Intervention

Diagnostic Test:
• Health-related physical fitness assessment
Participants will complete several questionnaires and perform multiple health-related physical fitness tests

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center +	Maastricht	Limburg

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	Dutch Gastroenterology & Hepatology Foundation (Maag Lever Darm Stichting)

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient characteristics	e.g., age, gender, medical history, comorbidities, IBD phenotype, disease duration, extra-intestinal manifestation, medication use, tobacco use	At time of inclusion (cross sectional study design)
Primary	Duke Activity Status Index	Outcome: estimated VO2peak	Study visit 1, at time of inclusion (cross sectional study design)
Primary	Veterans-Specific Activity Questionnaire	Outcome: estimated METs	Study visit 1, at time of inclusion (cross sectional study design)
Primary	Sum of 4 skinfold thicknessess	Outcome: % body fat, fat mass, fat free mass	Study visit 1, at time of inclusion (cross sectional study design)
Primary	Bioelectrical impedance analysis	Outcome: % body fat, fat mass, fat free mass	Study visit 1, at time of inclusion (cross sectional study design)
Primary	Mid upper arm circumference	Outcome: cm	Study visit 1, at time of inclusion (cross sectional study design)
Primary	Waist circumference	Outcome: cm	Study visit 1, at time of inclusion (cross sectional study design)
Primary	Steep ramp test (peak work rate)	Outcome: peak work rate	Study visit 1, at time of inclusion (cross sectional study design)
Primary	Handgrip strength	Outcome: kg	Study visit 1, at time of inclusion (cross sectional study design)
Primary	Handgrip endurance	Outcome: seconds to task failure (sec)	Study visit 1, at time of inclusion (cross sectional study design)
Primary	Handheld dynamometry	Outcome: peak torque	Study visit 1, at time of inclusion (cross sectional study design)
Primary	1 minute sit-to-stand test	Outcome: repetitions	Study visit 1, at time of inclusion (cross sectional study design)
Primary	sit-and-reach test	Outcome: cm	Study visit 1, at time of inclusion (cross sectional study design)
Primary	Deuterium oxide dilution (Only applicable for first 50 included patients with IBD)	Outcome: % body fat, fat mass, fat free mass).	Study visit 2, 7 to 14 days after inclusion (cross sectional study design)
Primary	Cardiopulmonary exercise test (Only applicable for first 50 included patients with IBD)	Outcome: VO2max/VO2peak)	Study visit 2, 7 to 14 days after inclusion (cross sectional study design)
Primary	Biodex 4 Pro dynamometry (Only applicable for first 50 included patients with IBD)	Outcome: peak torque	Study visit 2, 7 to 14 days after inclusion (cross sectional study design)
Secondary	International Physical Activity Questionnaire	Outcome: MET min/week	Study visit 1, at time of inclusion (cross sectional study design)
Secondary	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	7 days (between 1st and 2nd study visit)
Secondary	Checklist Individual Strength	Outcome: fatigue	Study visit 1, at time of inclusion (cross sectional study design)