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临床试验/NCT07129538
NCT07129538招募中不适用

Outcomes of Inspiratory Muscle Training in FMF Adolescents

Cairo University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年5月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
1
主要终点
Multidimensional Scale of Fatigue extracted from total score of pediatric quality of life

研究概览

简要总结

Familial mediterranean fever (FMF) is common to be diagnosed before age of 18 . this disorder is connected with deterioration in exercise tolerance, pulmonary capacities, fatigue tolerance,

详细描述

Familial mediterranean fever (FMF adolescents ) will be collected to be cateogarized to inspiratory muscle retraining group (IMR group) or control waitlist grouping. every group OF FMF will contain 20 FMF adolescents. IMR group will receive two IMR sessions daily, five times weekly, for eight weeks (every IMR session will contain 3 sets of IMR and the set will contain 10 breath cycles).. both groups will receive their prescribed colchicine medications daily

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
13 Years 至 17 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •FMF adolecents
  • •ages 13 -17 years
  • •forty patients

排除标准

  • •cardiac problems
  • •renal problems
  • •liver problems
  • •brain problems

研究组 & 干预措施

IMR group

Experimental

Familial mediterranean fever (FMF adolescents ) in this inspiratory muscle retraining group (IMR group) will contain 20 FMF adolescents. IMR group will receive two IMR sessions daily, five times weekly, for eight weeks (every IMR session will contain 3 sets of IMR and the set will contain 10 breath cycles).. also this group will receive their prescribed colchicine medications daily

干预措施: inspiratory muscle retraining (Other)

control group

Other

Familial mediterranean fever (FMF adolescents ) will be group of FMF will contain 20 FMF adolescents. this group will receive their prescribed colchicine medications daily

干预措施: colchicine only (Other)

结局指标

主要结局

Multidimensional Scale of Fatigue extracted from total score of pediatric quality of life

时间窗: it will be measured after 8 weeks

it will assess fatigue perception

次要结局

  • Forced vital capacity(it will be measured after 8 weeks)
  • general fatigue subscale of Multidimensional Scale of Fatigue related pediatric quality of life(it will be measured after 8 weeks)
  • cognitive fatigue subscale of Multidimensional Scale of Fatigue related pediatric quality of life(it will be measured after 8 weeks)
  • sleep and rest fatigue subscale of Multidimensional Scale of Fatigue related pediatric quality of life(it will be measured after 8 weeks)
  • six minute walk distance(it will be measured after 8 weeks)
  • Ration of Forced exhalation volume (at first second of exhalation) to forced exhalation capacity(it will be measured after 8 weeks)
  • Forced exhalation volume (at first second of exhalation)(it will be measured after 8 weeks)
  • maximum inhalation pressure(it will be measured after 8 weeks)
  • physical sum of child health qestionnaire(it will be measured after 8 weeks)
  • mental sum of child health qestionnaire(it will be measured after 8 weeks)

研究者

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

Ali Mohamed Ali ismail

lecturer of physical therapy for Cardiovascular, Respiratory disorder and Geriatrics, Faculty of Physical Therapy, Cairo University

Cairo University

研究点 (1)

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