Health-related Physical Fitness in Patients with Inflammatory Bowel Disease

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

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.

Study Overview

• Status: Completed
• Conditions: Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis
• Intervention / Treatment: Diagnostic test: Health-related physical fitness assessment

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.

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• Netherlands
  • Limburg
    • Maastricht, Limburg, Netherlands, 6200 MD
      • Maastricht University Medical Center +

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with IBD; 100 patients with IBD; either Ulcerative Colitis (N=50) or Crohns disease (N=50)	Diagnostic test: Health-related physical fitness assessment; Participants will complete several questionnaires and perform multiple health-related physical fitness tests
Healthy volunteers without IBD; 100 healthy volunteers (without IBD)	Diagnostic test: Health-related physical fitness assessment; Participants will complete several questionnaires and perform multiple health-related physical fitness tests

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duke Activity Status Index	Outcome: estimated VO2peak	Study visit 1, at time of inclusion (cross sectional study design)
Veterans-Specific Activity Questionnaire	Outcome: estimated METs	Study visit 1, at time of inclusion (cross sectional study design)
Sum of 4 skinfold thicknessess	Outcome: % body fat, fat mass, fat free mass	Study visit 1, at time of inclusion (cross sectional study design)
Bioelectrical impedance analysis	Outcome: % body fat, fat mass, fat free mass	Study visit 1, at time of inclusion (cross sectional study design)
Mid upper arm circumference	Outcome: cm	Study visit 1, at time of inclusion (cross sectional study design)
Waist circumference	Outcome: cm	Study visit 1, at time of inclusion (cross sectional study design)
Steep ramp test (peak work rate)	Outcome: peak work rate	Study visit 1, at time of inclusion (cross sectional study design)
Handgrip strength	Outcome: kg	Study visit 1, at time of inclusion (cross sectional study design)
Handgrip endurance	Outcome: seconds to task failure (sec)	Study visit 1, at time of inclusion (cross sectional study design)
Handheld dynamometry	Outcome: peak torque	Study visit 1, at time of inclusion (cross sectional study design)
1 minute sit-to-stand test	Outcome: repetitions	Study visit 1, at time of inclusion (cross sectional study design)
sit-and-reach test	Outcome: cm	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).	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)	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	Study visit 2, 7 to 14 days after inclusion (cross sectional study design)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
International Physical Activity Questionnaire	Outcome: MET min/week	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	7 days (between 1st and 2nd study visit)
Checklist Individual Strength	Outcome: fatigue	Study visit 1, at time of inclusion (cross sectional study design)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center
• Collaborators: Dutch Gastroenterology & Hepatology Foundation (Maag Lever Darm Stichting)
• Investigators: Principal Investigator: M.J. Pierik, Prof., Maastricht University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2022
• Primary Completion (Actual): September 27, 2024
• Study Completion (Actual): September 27, 2024

Study Registration Dates

• First Submitted: July 19, 2022
• First Submitted That Met QC Criteria: July 28, 2022
• First Posted (Actual): August 1, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 12, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Ulcerative Colitis; Crohn Disease; Inflammatory bowel disease; Health-related physical fitness
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Colitis; Colitis, Ulcerative; Crohn Disease; Intestinal Diseases; Inflammatory Bowel Diseases
• Other Study ID Numbers: NL79305.068.22; ZP 21-13 (Other Grant/Funding Number: Dutch Gastroenterology & Hepatology Foundation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No