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临床试验/NCT03069625
NCT03069625已完成不适用

Sit-to-stand Test Use in Children and Adolescents With Cystic Fibrosis : Correlations With 6-Minute Walking Test, Quadriceps and Respiratory Muscle Strength and Health Related Quality of Life

Groupe Hospitalier du Havre5 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2017年8月31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
36
试验地点
5
主要终点
Correlation between number of repetitions (STS Test) and 6-Minute Walking Distance

研究概览

简要总结

Cystic fibrosis (CF) is a chronic hereditary respiratory disease. Exercise testing is part of CF patients regular assessment.

Cardio-Pulmonary Exercise Testing (CPET) is currently considered as the gold standard to assess physical capacities. However, simple field tests are emerging. These tests are easier to perform especially in a population of CF children and adolescents.

The 1minute Sit-To-Stand test have recently been evaluated in CF adults. This test correlates with maximal oxygen consumption during CPET.

The investigators hypothesized that this test also correlates with 6-Minute Walking distance (during a 6-min Walk Test), quadriceps strength, respiratory muscles strength and health-related quality of life.

研究设计

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

入排标准

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

入选标准

  • Cystic Fibrosis
  • Exacerbation-free last month before inclusion

排除标准

  • Cardiovascular, neurological or musculoskeletal contra-indications to exercise testing
  • Other respiratory disease (kyphoscoliosis, asthma ...)
  • Exacerbation
  • Unability to carry out field tests

结局指标

主要结局

Correlation between number of repetitions (STS Test) and 6-Minute Walking Distance

时间窗: This outcome will be measured after both tests realization up to 15 minutes.

Comparison between the results of these two submaximal exercise tests

次要结局

  • Correlation between number of repetitions (STS test) and Maximal Inspiratory Pressure (MIP)(MIP will be measured after inclusion in the hour before field tests realization.)
  • Correlation between number of repetitions (STS test) and Maximal Expiratory Pressure (MEP)(MEP will be measured after inclusion in the hour before field tests realization.)
  • Correlation between number of repetitions (STS Test) and health-related quality of life(HRQoL testing will be carried out after inclusion in the hour before field tests realization.)
  • Differences in dyspnea and muscular fatigue.(These outcomes will be assessed during both field tests. These tests will be separate by a 30 minutes rest period. Date will be collected at the end of each test up to 15 minutes.)
  • Correlation between number of repetitions (STS Test) and forced vital capacity (FVC)(Spirometric test will be carried out before field tests realization.)
  • Correlation between number of repetitions (STS Test) and number of exacerbations / year.(Number of exacerbations / year will assess the number of exacerbations in the last year before inclusion and will be assessed during the initial survey in the hour before field test realization.)
  • Differences in Respiratory Rate.(These outcomes will be assessed during both field tests. These tests will be separate by a 30 minutes rest period. Date will be collected at the end of each test up to 15 minutes)
  • Correlation between number of repetitions (STS Test) and quadriceps strength.(Quadriceps strength will be assessed after inclusion in the hour before field tests realization.)
  • Correlation between number of repetitions (STS Test) and forced expiratory volume in 1 second (FEV1)(Spirometric test will be carried out in the last 3 months before field tests realization.)
  • Differences in Heart Rate.(These outcomes will be assessed during both field tests. These tests will be separate by a 30 minutes rest period. Date will be collected at the end of each test up to 15 minutes.)
  • Differences in Oxygen Saturation.(These outcomes will be assessed during both field tests. These tests will be separate by a 30 minutes rest period. Date will be collected at the end of each test up to 15 minutes.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (5)

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