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临床试验/NCT05099653
NCT05099653Unknown不适用

Study of the Impact of a Physical Activity Programme on the Quality of Life of Patients With Inflammatory Bowel Disease

Raincy Montfermeil Hospital Group2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年2月20日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
30
试验地点
2
主要终点
THE IMPACT OF A PHYSICAL ACTIVITY PROGRAM ON THE QUALITY OF LIFE OF PATIENTS

研究概览

简要总结

Regular physical activity at a mild to moderate intensity can control inflammation in general and intestinal inflammation in particular during IBD. The effectiveness of a physical activity programme has been evaluated during IBD, but the data are limited to a few studies. Overall, PA improves quality of life but also improves control of disease symptoms and fatigue . The aim of the present work is to evaluate the impact of a physical activity programme on quality of life in patients with IBD. This programme will also evaluate the impact of physical activity on 1) anxiety-depression, 2) fatigue (a frequent and difficult to manage symptom in IBD), 3) IBD activity, 4) smoking cessation.

详细描述

Crohn's disease and haemorrhagic rectocolitis are Chronic Inflammatory Bowel Diseases (CIBD) which evolve by flare-ups interspersed with periods of remission . The incidence of these two diseases is increasing in France in adults but also and especially in children and adolescents. Indeed, according to data from the EPIMAD registry, from 1988-1990 to 2009-2011, a significant increase in the incidence of both Crohn's disease and haemorrhagic rectocolitis was observed in adolescents (10-16 years): for Crohn's disease from 4.2 to 9.5/10 5 (+126%; P <0.001) and for UC from 1.6 to 4.1/10 5 (+156%; P <0.001). Over the long term, Crohn's disease can progress to intestinal destruction that can be complicated by stricture(s), obstruction(s), fistula(s) and/or abscesses leading to surgical treatment estimated at 50% after 10 years of Crohn's disease progression 1.

Anti-TNFα therapies are widely prescribed for Crohn's disease because they control symptoms, heal the mucosa, reduce hospital admissions and improve quality of life. However, they are associated with side effects often reported by patients, such as asthenia, weight gain and joint pain, symptoms that could be improved by regular physical activity.

Regular physical activity at a mild to moderate intensity can control inflammation in general and intestinal inflammation in particular during IBD. The effectiveness of a physical activity programme has been evaluated during IBD, but the data are limited to a few studies. Overall, PA improves quality of life but also improves control of disease symptoms and fatigue . The aim of the present work is to evaluate the impact of a physical activity programme on quality of life in patients with IBD. This programme will also evaluate the impact of physical activity on 1) anxiety-depression, 2) fatigue (a frequent and difficult to manage symptom in IBD), 3) IBD activity, 4) smoking cessation.

研究设计

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient followed for IBD in the hospital of Montfermeil
  • over 18 years of age
  • medical certificate authorising the practice of physical activity
  • Informed consent

排除标准

  • Age < 18 years
  • Medical contraindication to physical activity
  • Objection to participation in this study

结局指标

主要结局

THE IMPACT OF A PHYSICAL ACTIVITY PROGRAM ON THE QUALITY OF LIFE OF PATIENTS

时间窗: 6 months

EVALUATE THE IMPACT OF A PHYSICAL ACTIVITY PROGRAM ON THE QUALITY OF LIFE OF PATIENTS WITH IBD (assessment by IBDQ score)

次要结局

  • the impact of the physical activity programme on Psychological state(6 months)
  • the impact of the physical activity programme on fatigue (FACIT score)(6 months)

研究者

发起方
Raincy Montfermeil Hospital Group
申办方类型
Network
责任方
Sponsor

研究点 (2)

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