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临床试验/NCT03832491
NCT03832491已完成不适用

Effect of Game Based Approach on Oxygenation, Functional Capacity and Quality of Life in Primary Ciliary Dyskinesia

Hacettepe University2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2019年5月20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
32
试验地点
2
主要终点
Functional capacity using six minute walk test

研究概览

简要总结

Impaired pulmonary function, decreased physical activity, functional capacity and depending on these factors are reported in patients with primary ciliary dyskinesia in recent studies. The purpose of this study to evaluate the effects of game based approach on pulmonary function, functional capacity and quality of life in patients with primary ciliary dykinesia.

详细描述

Primary ciliary dyskinesia (PCD) is an autosomal recessive hereditary disorder characterized by congenital structural abnormalities and impairment of respiratory function. Mucociliary clearance is affected by disorders in the structure and movement of cilia. That causes repeated infections in the upper and lower respiratory tract.In addition to mucociliary effects and impaired lung function, it is thought that there may be a decrease in respiratory muscle strength and functional capacity. One of the factors affecting functional capacity is the level of physical activity. For these reasons, the management of the respiratory system in patients with PCD is very important. In addition to airway clearence techniques, approaches to increase physical activity are also important. It was thought that severe physical activity could be an important determinant of cardiopulmonary functional capacity in patients with mild to moderate PCD. The level of physical activity is known to be associated with quality of life.

In literature no study investigated the effects of game based approach on oxygenation, functional capacity and quality of life in patients with PCD. Game based approach is a new method lead to increase physical activity. In literature there is no study investigated the effects of game based approach on oxygenation, functional capacity and quality of life in patients with PCD.

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

入选标准

  • Being diagnosed with PCD
  • Being clinically stable
  • Between 6-18 years old
  • Volunteer to participate in research

排除标准

  • Not having a stable clinical condition
  • Patients with severe neuromuscular, musculoskeletal and rheumatological problems
  • Patients with loss of balance
  • Not being cooperative

结局指标

主要结局

Functional capacity using six minute walk test

时间窗: Change from baseline distance of six minute walk test in 8 weeks

Six minute walk test will be performed in a long, straight, enclosed corridor 30 meters in length. Patients are required to walk in their walking speed with standardized instructions.

Distance of six minute walk test

时间窗: Change from baseline distance of six minute walk test in 8 weeks

The distance walked will be recorded as meters at the end of 6 minute walk test.

次要结局

  • Demographic features-Age(Before and after 8 weeks)
  • Demographic features-Weight(Before and after 8 weeks)
  • Demographic features-Body Mass Index(Before and after 8 weeks)
  • Vital Signs-Diastolic Blood Pressure(Before and after 8 weeks)
  • Pulmonary function(Before and after 8 weeks)
  • Statical Balance(Before and after 8 weeks)
  • Demographic features-Lenght(Before and after 8 weeks)
  • Vital Signs-Perception of dyspnea(Before and after 8 weeks)
  • Perception of quadriceps fatigue(Before and after 8 weeks)
  • Respiratory muscle strength(Before and after 8 weeks)
  • Extending distance in Y Balance Test(Before and after 8 weeks)
  • Daily energy consumption in the Bouchard Three-Day Physical Activity Questionnare(Before and after 8 weeks)
  • Energy expenditure while playing seated games.(Before and after 8 weeks)
  • Vital Signs-Respiratory Rate(Before and after 8 weeks)
  • Peripheral muscle strength(Before and after 8 weeks)
  • Subjective Physical Activity(Before and after 8 weeks)
  • Energy expenditure while playing each kinect games.(Week one and half)
  • Exercise capacity using incremental shuttle walk test.(Before and after 8 weeks)
  • Vital Signs-Heart Rate(Before and after 8 weeks)
  • Vital Signs-Systolic Blood Pressure(Before and after 8 weeks)
  • Perception of general fatigue(Before and after 8 weeks)
  • Loss of balance of Flamingo Balance Test(Before and after 8 weeks)
  • Objective Physical Activity(Before and after 8 weeks)
  • Oxygenation using wearable lactate measuring instrument (BSX insight device) during Glittre Activity of Daily Living Test.(Before and after 8 weeks)
  • Dynamic Balance(Before and after 8 weeks)
  • Activity of Daily Living(Before and after 8 weeks)
  • Oxygenation using wearable lactate measuring instrument (BSX insight device) during Incremental Shuttle Walk Test.(Before and after 8 weeks)
  • Quality of daily living using disease specific questioannare-Version2 (QOL-PCDV2)(Before and after 8 weeks)

研究者

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

Hazal Sonbahar Ulu

MSc, PT

Hacettepe University

研究点 (2)

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