The Numbers Tell the Tale: the Validation of an Assessment Battery for Health-related Physical Fitness in Patients with Inflammatory Bowel Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Veterans-Specific Activity Questionnaire
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Veterans-Specific Activity Questionnaire
时间窗: Study visit 1, at time of inclusion (cross sectional study design)
Outcome: estimated METs
Sum of 4 skinfold thicknessess
时间窗: Study visit 1, at time of inclusion (cross sectional study design)
Outcome: % body fat, fat mass, fat free mass
Duke Activity Status Index
时间窗: Study visit 1, at time of inclusion (cross sectional study design)
Outcome: estimated VO2peak
Mid upper arm circumference
时间窗: Study visit 1, at time of inclusion (cross sectional study design)
Outcome: cm
sit-and-reach test
时间窗: 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)
时间窗: Study visit 2, 7 to 14 days after inclusion (cross sectional study design)
Outcome: peak torque
Waist circumference
时间窗: Study visit 1, at time of inclusion (cross sectional study design)
Outcome: cm
Handgrip endurance
时间窗: Study visit 1, at time of inclusion (cross sectional study design)
Outcome: seconds to task failure (sec)
1 minute sit-to-stand test
时间窗: Study visit 1, at time of inclusion (cross sectional study design)
Outcome: repetitions
Bioelectrical impedance analysis
时间窗: 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)
时间窗: Study visit 2, 7 to 14 days after inclusion (cross sectional study design)
Outcome: VO2max/VO2peak)
Steep ramp test (peak work rate)
时间窗: Study visit 1, at time of inclusion (cross sectional study design)
Outcome: peak work rate
Handgrip strength
时间窗: Study visit 1, at time of inclusion (cross sectional study design)
Outcome: kg
Handheld dynamometry
时间窗: 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)
时间窗: Study visit 2, 7 to 14 days after inclusion (cross sectional study design)
Outcome: % body fat, fat mass, fat free mass).
次要结局
- Total physical activity measured with accelerometer (Only applicable for first 50 included patients with IBD)(7 days (between 1st and 2nd study visit))
- International Physical Activity Questionnaire(Study visit 1, at time of inclusion (cross sectional study design))
- Checklist Individual Strength(Study visit 1, at time of inclusion (cross sectional study design))