Inflammatory Bowel DiseasesNCT05482932
Health-related Physical Fitness in Patients with Inflammatory Bowel Disease
An observational study of Inflammatory Bowel Diseases and Ulcerative Colitis, run by Maastricht University Medical Center at 1 site in Netherlands.
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Bowel Diseases, Ulcerative Colitis, Crohn Disease
- What is being tested?
- Health-related physical fitness assessment
- How many people
- 200 participants
- Where
- 1 siteNetherlands
- Study dates
- 17 Aug 2022to 27 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
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- 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.
- No certified diagnosis of IBD (CD, UC, IBD-Unclassified);
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Center +
Maastricht, Limburg, 6200 MD
About this study
Official title: 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.
Read the 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.
- Being tested
- Health-related physical fitness assessment
- Keywords
- Inflammatory bowel disease, Ulcerative Colitis, Crohn Disease, Health-related physical fitness
- Medical subject headings
- Inflammatory Bowel Diseases, Colitis, Ulcerative, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health-related physical fitness assessmentDiagnostic test
Participants will complete several questionnaires and perform multiple health-related physical fitness tests
| Study group | Role | What they receive |
|---|---|---|
| Patients with IBD | 100 patients with IBD; either Ulcerative Colitis (N=50) or Crohns disease (N=50) Receives: Diagnostic Test: Health-related physical fitness assessment | |
| Healthy volunteers without IBD | 100 healthy volunteers (without IBD) Receives: Diagnostic Test: Health-related physical fitness assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duke Activity Status Index
Outcome: estimated VO2peak
Measured: Study visit 1, at time of inclusion (cross sectional study design)
Veterans-Specific Activity Questionnaire
Outcome: estimated METs
Measured: Study visit 1, at time of inclusion (cross sectional study design)
Sum of 4 skinfold thicknessess
Outcome: % body fat, fat mass, fat free mass
Measured: Study visit 1, at time of inclusion (cross sectional study design)
Bioelectrical impedance analysis
Outcome: % body fat, fat mass, fat free mass
Measured: Study visit 1, at time of inclusion (cross sectional study design)
Mid upper arm circumference
Outcome: cm
Measured: Study visit 1, at time of inclusion (cross sectional study design)
Waist circumference
Outcome: cm
Measured: Study visit 1, at time of inclusion (cross sectional study design)
Steep ramp test (peak work rate)
Outcome: peak work rate
Measured: Study visit 1, at time of inclusion (cross sectional study design)
Handgrip strength
Outcome: kg
Measured: Study visit 1, at time of inclusion (cross sectional study design)
Handgrip endurance
Outcome: seconds to task failure (sec)
Measured: Study visit 1, at time of inclusion (cross sectional study design)
Handheld dynamometry
Outcome: peak torque
Measured: Study visit 1, at time of inclusion (cross sectional study design)
1 minute sit-to-stand test
Outcome: repetitions
Measured: Study visit 1, at time of inclusion (cross sectional study design)
sit-and-reach test
Outcome: cm
Measured: 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).
Measured: 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)
Measured: 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
Measured: Study visit 2, 7 to 14 days after inclusion (cross sectional study design)
Secondary outcomes (3)
International Physical Activity Questionnaire
Outcome: MET min/week
Measured: 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
Measured: 7 days (between 1st and 2nd study visit)
Checklist Individual Strength
Outcome: fatigue
Measured: Study visit 1, at time of inclusion (cross sectional study design)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2022
- Study start17 Aug 2022
- Primary completion27 Sep 2024
- Study completion27 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Gastroenterology & Hepatology Foundation (Maag Lever Darm Stichting)
- Responsible party
- Sponsor
- Investigators
- M.J. Pierik, Prof., Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05482932
- Sponsor's protocol ID
- NL79305.068.22
- Other IDs
- ZP 21-13
- Status last verified
- Dec 2024
- First submitted
- 19 Jul 2022
- Last updated
- 17 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Demers K, van den Bergh N, Bongers BC, van Kuijk SMJ, Mujagic Z, Jonkers DMAE, Pierik MJ, Stassen LPS. Health-Related Physical Fitness in Patients With Inflammatory Bowel Disease vs Healthy Control Subjects. Inflamm Bowel Dis. 2025 Dec 1;31(12):3337-3355. doi: 10.1093/ibd/izaf169.
PubMed 41060265
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Numbers Tell the Tale: the Validation of an Assessment Battery for Health-related Physical Fitness in Patients with Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT05482932
- Acronym / sponsor ID
- NL79305.068.22
- Keywords
- Inflammatory bowel disease, Ulcerative Colitis, Crohn Disease, Health-related physical fitness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Dutch Gastroenterology & Hepatology Foundation (Maag Lever Darm Stichting)
- Study start
- 17 Aug 2022 (actual)
- Primary completion
- 27 Sep 2024 (actual)
- Study completion
- 27 Sep 2024 (actual)
- First posted
- 1 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with IBD | – | Diagnostic Test: Health-related physical fitness assessment100 patients with IBD; either Ulcerative Colitis (N=50) or Crohns disease (N=50) |
| Healthy volunteers without IBD | – | Diagnostic Test: Health-related physical fitness assessment100 healthy volunteers (without IBD) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health-related physical fitness assessmentParticipants will complete several questionnaires and perform multiple health-related physical fitness tests | Diagnostic test | Healthy volunteers without IBD, Patients with IBD |
Primary outcome
Duke Activity Status Index
Time frame: Study visit 1, at time of inclusion (cross sectional study design)
Outcome: estimated VO2peak
Veterans-Specific Activity Questionnaire
Time frame: Study visit 1, at time of inclusion (cross sectional study design)
Outcome: estimated METs
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
Bioelectrical impedance analysis
Time frame: Study visit 1, at time of inclusion (cross sectional study design)
Outcome: % body fat, fat mass, fat free mass
Mid upper arm circumference
Time frame: Study visit 1, at time of inclusion (cross sectional study design)
Outcome: cm
Waist circumference
Time frame: Study visit 1, at time of inclusion (cross sectional study design)
Outcome: cm
Steep ramp test (peak work rate)
Time frame: Study visit 1, at time of inclusion (cross sectional study design)
Outcome: peak work rate
Handgrip strength
Time frame: Study visit 1, at time of inclusion (cross sectional study design)
Outcome: kg
Handgrip endurance
Time frame: Study visit 1, at time of inclusion (cross sectional study design)
Outcome: seconds to task failure (sec)
Handheld dynamometry
Time frame: Study visit 1, at time of inclusion (cross sectional study design)
Outcome: peak torque
1 minute sit-to-stand test
Time frame: Study visit 1, at time of inclusion (cross sectional study design)
Outcome: repetitions
sit-and-reach test
Time frame: Study visit 1, at time of inclusion (cross sectional study design)
Outcome: cm
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).
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)
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
3 secondary outcomes
International Physical Activity Questionnaire
Time frame: 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)
Time frame: 7 days (between 1st and 2nd study visit)
Checklist Individual Strength
Time frame: Study visit 1, at time of inclusion (cross sectional study design)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2024.
- Derived from this study: PubMed 41060265Demers K, van den Bergh N, Bongers BC, van Kuijk SMJ, Mujagic Z, Jonkers DMAE, Pierik MJ, Stassen LPS. Health-Related Physical Fitness in Patients With Inflammatory Bowel Disease vs Healthy Control Subjects. Inflamm Bowel Dis. 2025 Dec 1;31(12):3337-3355. doi: 10.1093/ibd/izaf169.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
M.J. Pierik, Prof. principal investigator
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Diseases and Ulcerative Colitis, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duke Activity Status Index (time frame: Study visit 1, at time of inclusion (cross sectional study design)). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05482932, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2024.