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临床试验/NCT04589338
NCT04589338已完成不适用

Impact of Different Types of Physical Activity in Patients With Chronic Inflammatory Bowel Disease

University of Liege2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2021年1月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
2
主要终点
Short health scale questionnaire

研究概览

简要总结

This is a prospective interventional study. The investigators will include patients in clinical remission who are on stable treatment. These IBD patients will be followed to analyze the effects of physical activity on their inflammatory disease. Different exercises will be offered to two separate groups of randomly distributed patients: the first group will perform muscle building exercises while the other group will be offered aerobic exercises.There will also be a control group that does not initially benefit from a specific physical activity program. However, this group will be integrated into one of the other two groups after the 10-week follow-up. All three groups will perform the same baseline tests. These will be of different types: physical tests, biological tests and quality of life questionnaires.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients in remission defined by a Harvey Bradshaw Index 5 in Crohn's disease (CD) and a clinical Mayo 3 with no sub-score >1 in ulcerative colitis (RCUH) with stable treatment, without corticosteroid for 4 months.
  • Patients accepting the study protocol

排除标准

  • Patients suffering from other pathologies (at the level of the digestive system, the cardiovascular system, as well as the musculoskeletal system: recent knee plasty, recent knee fractures, etc.), which can interfere with planned tests and activity programs.
  • Patients with more than 3 hours of sports activity per week
  • Pregnant, pregnant or nursing patients

结局指标

主要结局

Short health scale questionnaire

时间窗: Week 20

Participants will complete a questionnaire to evaluate the level of the inflammatory bowel disease

EQ5D questionnaire

时间窗: Week 20

Participants will complete a questionnaire on their level of health

Short Food Frequency Questionnaire

时间窗: Week 20

Participants will complete a questionnaire on their dietary habits

Progressive effort test on bicycle ergometer (VO2 max)

时间窗: through study completion, an average of 40 weeks

This test allows to measure VO2 in ml/min/kg (thanks to respiratory gases)

Progressive effort test on bicycle ergometer (Power)

时间窗: through study completion, an average of 40 weeks

This test allows to measure maximum aerobic power in Watt.

Blood sample

时间窗: through study completion, an average of 40 weeks

This type of tests includes biological monitoring to obtain information on biological parameters.

Saddle analysis

时间窗: through study completion, an average of 40 weeks

This type of tests includes biological monitoring to obtain information on biological parameters.

IBD-F

时间窗: Week 20

Participants will complete a questionnaire on fatigue perceived.

Progressive effort test on bicycle ergometer (Heart rate)

时间窗: through study completion, an average of 40 weeks

This test allows to measure resting and maximum heart rate (thanks to an ECG) and maximum aerobic power in Watt.

Maximum force test (N/m)

时间窗: through study completion, an average of 40 weeks

This test will be performed using an isokinetic dynamometer. This evaluation will allow us to determine the maximum force of the quadriceps and hamstrings of each participant in N/m.

Godin Leisure Time exercise questionnaire

时间窗: Week 1

Participants will complete a questionnaire on the level of physical activity

Metabolic Equivalent Task questionnaire

时间窗: Week 20

Participants will complete a questionnaire on the level of inactivity

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gofflot Amandine

Principal Investigator

University of Liege

研究点 (2)

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