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临床试验/NCT04724993
NCT04724993Unknown不适用

Comparison the Effectiveness of Online Aerobic Dance Exercises Versus Physical Activity Counseling in Patients With Juvenile Familial Mediterranean Fever

Istanbul University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年12月20日最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
试验地点
2
主要终点
Six Minute Walk Test

研究概览

简要总结

The aim of the study is to investigate comparison the effectiveness of online aerobic dance exercises versus physical activity counselling in patients with Juvenile Familial Mediterranean Fever.

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 (Participant)

入排标准

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

入选标准

  • To be under colchicine treatment for at least 3 months
  • Being in an attack-free period

排除标准

  • Attack in the last 2 weeks
  • Having any systemic chronic disease except Familial Mediterranean Fever
  • Presence of amyloidosis
  • Having arthritis that may prevent participation in exercise

结局指标

主要结局

Six Minute Walk Test

时间窗: Change from baseline to 8 weeks

The 6-minute walk test is a well tolerated, easy-to-apply and a simple test that shows the submaximal level of functional capacity. This test measures the distance that patients can walk quickly on a hard and flat surface within 6 minutes. Patients will be rested in a chair near by the starting position for at least 10 minutes before the test begins. Heart rate, blood plessure, saturation and fatigue levels will be determined by a physiotherapist before and after the test. At the end of the test, the distance walked by the patients within 6 minutes will be recorded in meters.

次要结局

  • Back saver Sit and Reach Test(Change from baseline to 8 weeks)
  • Familial Mediterranean Fever Quality of Life Scale (FMF-QoL)(Change from baseline to 8 weeks)
  • Progressive Aerobic Cardiovascular Endurance Run (PACER)(Change from baseline to 8 weeks)
  • Physical Activity Questionnaire for Older Children (PAQ-C)(Change from baseline to 8 weeks)
  • Curl Up Test(Change from baseline to 8 weeks)
  • Trunk Lift Test(Change from baseline to 8 weeks)
  • Push Up Test(Change from baseline to 8 weeks)
  • Visual Analogue Scale for Fatigue(Change from baseline to 8 weeks)
  • Visual Analogue Scale(Change from baseline to 8 weeks)
  • Skinfold Thickness Measurement and Bioelectrical Impedance Analysis(Change from baseline to 8 weeks)
  • PedsQL™ Multidimensional Fatigue Scale(Change from baseline to 8 weeks)
  • Physical Activity Questionnaire for Adolescents (PAQ-A)(Change from baseline to 8 weeks)

研究者

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

Saime Nilay Arman

Assist.Prof.

Istanbul University

研究点 (2)

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