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Health-related Physical Fitness in Patients with Inflammatory Bowel Disease

NCT05482932 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2024-12-17

No results posted yet for this study

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.

Conditions

Interventions

DIAGNOSTIC_TEST

Health-related physical fitness assessment

Participants will complete several questionnaires and perform multiple health-related physical fitness tests

Sponsors & Collaborators

  • Dutch Gastroenterology & Hepatology Foundation (Maag Lever Darm Stichting)

    collaborator UNKNOWN

  • Maastricht University Medical Center

    lead OTHER

Principal Investigators

  • M.J. Pierik, Prof. · Maastricht University Medical Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-08-17
Primary Completion
2024-09-27
Completion
2024-09-27

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05482932 on ClinicalTrials.gov