Health-related Physical Fitness in Patients with Inflammatory Bowel Disease

NCT05482932 | Completed DMC

• 2 other identifiers: NL79305.068.22ZP 21-13
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Inflammatory Bowel Diseases; Ulcerative Colitis; Crohn Disease

Keywords

Inflammatory bowel disease; Ulcerative Colitis; Crohn Disease; Health-related physical fitness

Outcome Measures

Primary Outcomes (15)

• 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 Outcomes (3)

• International Physical Activity Questionnaire

  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)

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

• Checklist Individual Strength

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

Other Outcomes (1)

• Patient characteristics

  At time of inclusion (cross sectional study design)

Study Arms (2)

Patients with IBD

100 patients with IBD; either Ulcerative Colitis (N=50) or Crohns disease (N=50)

Diagnostic Test: Health-related physical fitness assessment

Healthy volunteers without IBD

100 healthy volunteers (without IBD)

Diagnostic Test: Health-related physical fitness assessment

Interventions

Health-related physical fitness assessment DIAGNOSTIC_TEST

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

Healthy volunteers without IBD; Patients with IBD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.
• 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);

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• Dutch Gastroenterology & Hepatology Foundation (Maag Lever Darm Stichting): collaborator

Study Sites (1)

Maastricht University Medical Center +

Maastricht, Limburg, 6200 MD, Netherlands

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Colitis, Ulcerative; Crohn Disease

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Officials

• M.J. Pierik, Prof.

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2022
• First Posted: August 1, 2022
• Study Start: August 17, 2022
• Primary Completion: September 27, 2024
• Study Completion: September 27, 2024
• Last Updated: December 17, 2024

Record last verified: 2024-12

Locations

NL (1)