Health-related Physical Fitness in Patients with Inflammatory Bowel Disease
- Conditions
- Ulcerative ColitisCrohn DiseaseInflammatory Bowel Diseases
- Interventions
- Diagnostic Test: Health-related physical fitness assessment
- Registration Number
- NCT05482932
- Lead Sponsor
- Maastricht University Medical Center
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Healthy volunteers without IBD Health-related physical fitness assessment 150 healthy volunteers (without IBD) Patients with IBD Health-related physical fitness assessment 150 patients with IBD; either Ulcerative Colitis (N=75) or Crohns disease (N=75)
- Primary Outcome Measures
Name Time Method Veterans-Specific Activity Questionnaire Study visit 1, at time of inclusion (cross sectional study design) Outcome: estimated METs
Sum of 4 skinfold thicknessess Study visit 1, at time of inclusion (cross sectional study design) Outcome: % body fat, fat mass, fat free mass
Duke Activity Status Index Study visit 1, at time of inclusion (cross sectional study design) Outcome: estimated VO2peak
Mid upper arm circumference Study visit 1, at time of inclusion (cross sectional study design) Outcome: cm
sit-and-reach test Study visit 1, at time of inclusion (cross sectional study design) Outcome: cm
Biodex 4 Pro dynamometry (Only applicable for first 50 included patients with IBD) Study visit 2, 7 to 14 days after inclusion (cross sectional study design) Outcome: peak torque
Waist circumference Study visit 1, at time of inclusion (cross sectional study design) Outcome: cm
Handgrip endurance Study visit 1, at time of inclusion (cross sectional study design) Outcome: seconds to task failure (sec)
1 minute sit-to-stand test Study visit 1, at time of inclusion (cross sectional study design) Outcome: repetitions
Bioelectrical impedance analysis Study visit 1, at time of 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) Study visit 2, 7 to 14 days after inclusion (cross sectional study design) Outcome: VO2max/VO2peak)
Steep ramp test (peak work rate) Study visit 1, at time of inclusion (cross sectional study design) Outcome: peak work rate
Handgrip strength Study visit 1, at time of inclusion (cross sectional study design) Outcome: kg
Handheld dynamometry Study visit 1, at time of inclusion (cross sectional study design) Outcome: peak torque
Deuterium oxide dilution (Only applicable for first 50 included patients with IBD) Study visit 2, 7 to 14 days after inclusion (cross sectional study design) Outcome: % body fat, fat mass, fat free mass).
- Secondary Outcome Measures
Name Time Method Total physical activity measured with accelerometer (Only applicable for first 50 included patients with IBD) 7 days (between 1st and 2nd study visit) Outcome: total physical activity, number of steps and intensity, time spent in posture and intensity
International Physical Activity Questionnaire Study visit 1, at time of inclusion (cross sectional study design) Outcome: MET min/week
Checklist Individual Strength Study visit 1, at time of inclusion (cross sectional study design) Outcome: fatigue
Trial Locations
- Locations (1)
Maastricht University Medical Center +
🇳🇱Maastricht, Limburg, Netherlands