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临床试验/NCT05147285
NCT05147285已完成不适用

The Effect of Different Exercise Modalities Applied by Tele Rehabilitation on Functional Capacity, Oxidative Stress and Respiratory Parameters in Cystic Fibrosis Children

Hacettepe University1 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2020年10月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
39
试验地点
1
主要终点
six minute walk test distance

研究概览

简要总结

The aim of this study is to examine the effects of different exercise modalities applied with tele-rehabilitation on functional capacity, oxidative stress and respiratory parameters in children with cystic fibrosis

详细描述

Cystic fibrosis (CF) is the most common life-shortening autosomal recessive disease among populations of caucasians with a frequency of 1 in 2000 to 3000 live births. The most common problems in these patients are increased bronchial secretion, decreased exercise capacity, and shortness of breath. In addition to progressive respiratory disease, peripheral and respiratory muscle function impairments, inflammation, and contribute to the decrease in exercise capacity in CF patients. Recent studies show that increased oxidative stress and impaired oxidant / antioxidant capacity have an important role in disease progression in CF patients. CF childrens may be more physically inactive. Cystic fibrosis transmembrane regulator (CFTR) modulators, airway clearance therapies, chest physiotherapy and exercise trainings are treatment options in these populations. Regular exercise which is the component of pulmonary rehabilitation (PR), is recommended for patients with CF. Aerobic exercise may help to mobilize secretions, in addition to providing the other known benefits of exercise in healthy individuals. Despite the benefits of PR programmes, low participant uptake, high drop-out rates, financial and transportation difficulties reduced the attendance in these programs. Different telemedicine treatments have been developed to overcome these difficulties and reduce healthcare costs. In recent studies, shows that tele-exercise is a promising new approach to promote exercise in children with CF. Although different exercise modalities such as aerobic exercise training and strength training have been investigated in CF patients, there is no study to examine stabilization exercises in this populations. Also there is no study to evaluate the effect of exercise training on irisin. In addition, although it is known that acute exercise has positive effects on both oxidant and antioxidant markers in the pediatric population, the effect of long-term exercise on oxidative stress has not been adequately studied. The aim of this study is to examine the effect of different exercise training modalities applied with telerehabilitation method on functional capacity, oxidative stress and respiratory parameters in CF patients. . In the study, after measuring respiratory functions, exercise capacity, oxidative stress parameters, peripheral muscle functions, balance, posture, quality of life and physical activity questionnaire, 39 people will be divided into three groups. First group will be applied only online supervised stabilization exercises, Second group will be applied online supervised aerobic exercise training and stabilization exercises. And the third group, the physical activity importance will be explained and appropriate physical activity recommendations will be made. All outcome measures will be repeated after exercise training.

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

入选标准

  • •Patients aged 8-18 years with a diagnosis of cystic fibrosis (CF)
  • •Access to online exercise training
  • •Percent predicted of forced expiratory volume at one second (FEV1) > 40% in pulmonary function test

排除标准

  • •Being diagnosed with acute pulmonary exacerbation at the time of study and / or within the last month.
  • •Being physically or perceptually competent to exercise
  • •Patients with allergic bronchopulmonary aspergillosis (ABPA) who were treated with systemic steroid therapy
  • •Having FEV1 %< 40% at pulmonary function test.

研究组 & 干预措施

Stabilization group

Experimental

Only stabilization exercises in patients with cystic fibrosis

干预措施: stabilization exercises (Other)

combined group

Experimental

stabilization exercise and aerobic exercise training in patients with cystic fibrosis

干预措施: combined exercises (Other)

control group

Experimental

physical activity recommendations in patients with cystic fibrosis

干预措施: Physical activity recommendations (Other)

结局指标

主要结局

six minute walk test distance

时间窗: eight week

Six-minute walk test distance is recorded

shuttle walk test distance

时间窗: eight week

shuttle walk test distance is recorded

six minute walk test distance

时间窗: before the exercise training

Six-minute walk test distance is recorded

shuttle walk test distance

时间窗: before exercise training

shuttle walk test distance is recorded

次要结局

  • squat repetitions(eight week)
  • Pulmonary functions-FEF25-75(eight week)
  • Pulmonary functions-PEF(eight week)
  • balance(eight week)
  • static balance(eight week)
  • dynamic balance(eight week)
  • Pulmonary functions-FEV1/FVC(eight week)
  • Respiratory muscle strength(eight week)
  • Respiratory muscle endurance(eight week)
  • Pulmonary functions-FVC(eight week)
  • Pulmonary functions-FEV1(eight week)
  • Oxidative stress-MDA(eight week)
  • Oxidative stress-SOD(eight week)
  • Oxidative stress-CAT(eight week)
  • Oxidative stress-PC(eight week)
  • Oxidative stress-TOS(eight week)
  • Oxidative stress-TAS(eight week)
  • Oxidative stress-oxidative stress index(eight week)
  • Peripheral muscle strength(eight week)
  • crunch repetitions(eight week)
  • push-up repetitions(eight week)
  • plank duration(eight week)
  • 1 minute sit to stand test (STS) repetitions(eight week)
  • myokine assessment(eight week)
  • posture-Corbin(eight week)
  • posture(eight week)
  • functional mobility(eight week)
  • Mcgill core endurance test(eight week)
  • Physical activity assessment(eight week)
  • Quality of life assessment(eight week)
  • Respiratory muscle strength(before exercise training)
  • Respiratory muscle endurance(before exercise training)
  • Pulmonary functions-FVC(before exercise training)
  • Pulmonary functions-FEV1(before exercise training)
  • Pulmonary functions-FEV1/FVC(before exercise training)
  • Pulmonary functions-PEF(before exercise training)
  • Pulmonary functions-FEF25-75(before exercise training)
  • Oxidative stress-MDA(before exercise training)
  • Oxidative stress-SOD(before exercise training)
  • Oxidative stress-CAT(before exercise training)
  • Oxidative stress-PC(before exercise training)
  • Oxidative stress-TOS(before exercise training)
  • Oxidative stress-TAS(before exercise training)
  • Oxidative stress-oxidative stress index(before exercise training)
  • Peripheral muscle strength(before exercise training)
  • crunch repetitions(before exercise training)
  • squat repetitions(before exercise training)
  • push-up repetitions(before exercise training)
  • plank duration(before exercise training)
  • 1 minute sit to stand test (STS) repetitions(before exercise training)
  • myokine assessment(before exercise training)
  • posture-Corbin(before exercise training)
  • posture(before exercise training)
  • balance(before exercise training)
  • static balance(before exercise training)
  • dynamic balance(before exercise training)
  • functional mobility(before exercise training)
  • Mcgill core endurance test(before exercise training)
  • Quality of life assessment(before exercise training)
  • Physical activity assessment(before exercise training)

研究者

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

Kübra Kılıç

Physiotherapist

Hacettepe University

研究点 (1)

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