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Completed

NCT Number: NCT05482932

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Maastricht University Medical Center +

Maastricht, Limburg, 6200 MD, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Health-related physical fitness assessment

Diagnostic Test

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

Primary outcomes

  1. Duke Activity Status Index

    Time frame: Study visit 1, at time of inclusion (cross sectional study design)

    Outcome: estimated VO2peak

  2. Veterans-Specific Activity Questionnaire

    Time frame: Study visit 1, at time of inclusion (cross sectional study design)

    Outcome: estimated METs

  3. Sum of 4 skinfold thicknessess

    Time frame: Study visit 1, at time of inclusion (cross sectional study design)

    Outcome: % body fat, fat mass, fat free mass

  4. Bioelectrical impedance analysis

    Time frame: Study visit 1, at time of inclusion (cross sectional study design)

    Outcome: % body fat, fat mass, fat free mass

  5. Mid upper arm circumference

    Time frame: Study visit 1, at time of inclusion (cross sectional study design)

    Outcome: cm

  6. Waist circumference

    Time frame: Study visit 1, at time of inclusion (cross sectional study design)

    Outcome: cm

  7. Steep ramp test (peak work rate)

    Time frame: Study visit 1, at time of inclusion (cross sectional study design)

    Outcome: peak work rate

  8. Handgrip strength

    Time frame: Study visit 1, at time of inclusion (cross sectional study design)

    Outcome: kg

  9. Handgrip endurance

    Time frame: Study visit 1, at time of inclusion (cross sectional study design)

    Outcome: seconds to task failure (sec)

  10. Handheld dynamometry

    Time frame: Study visit 1, at time of inclusion (cross sectional study design)

    Outcome: peak torque

  11. 1 minute sit-to-stand test

    Time frame: Study visit 1, at time of inclusion (cross sectional study design)

    Outcome: repetitions

  12. sit-and-reach test

    Time frame: Study visit 1, at time of inclusion (cross sectional study design)

    Outcome: cm

  13. Deuterium oxide dilution (Only applicable for first 50 included patients with IBD)

    Time frame: Study visit 2, 7 to 14 days after inclusion (cross sectional study design)

    Outcome: % body fat, fat mass, fat free mass).

  14. Cardiopulmonary exercise test (Only applicable for first 50 included patients with IBD)

    Time frame: Study visit 2, 7 to 14 days after inclusion (cross sectional study design)

    Outcome: VO2max/VO2peak)

  15. Biodex 4 Pro dynamometry (Only applicable for first 50 included patients with IBD)

    Time frame: Study visit 2, 7 to 14 days after inclusion (cross sectional study design)

    Outcome: peak torque

Secondary outcomes

  1. International Physical Activity Questionnaire

    Time frame: Study visit 1, at time of inclusion (cross sectional study design)

    Outcome: MET min/week

  2. Total physical activity measured with accelerometer (Only applicable for first 50 included patients with IBD)

    Time frame: 7 days (between 1st and 2nd study visit)

    Outcome: total physical activity, number of steps and intensity, time spent in posture and intensity

  3. Checklist Individual Strength

    Time frame: Study visit 1, at time of inclusion (cross sectional study design)

    Outcome: fatigue

Other outcomes

  1. Patient characteristics

    Time frame: At time of inclusion (cross sectional study design)

    e.g., age, gender, medical history, comorbidities, IBD phenotype, disease duration, extra-intestinal manifestation, medication use, tobacco use

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 1, 2022
Registry last updated
Dec 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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