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Clinical Trials/NCT05147285
NCT05147285
Completed
Not Applicable

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

Hacettepe University1 site in 1 country39 target enrollmentOctober 22, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cystic Fibrosis
Sponsor
Hacettepe University
Enrollment
39
Locations
1
Primary Endpoint
six minute walk test distance
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
October 22, 2020
End Date
May 20, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kübra Kılıç

Physiotherapist

Hacettepe University

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

six minute walk test distance

Time Frame: eight week

Six-minute walk test distance is recorded

shuttle walk test distance

Time Frame: eight week

shuttle walk test distance is recorded

Secondary Outcomes

  • Respiratory muscle strength(eight week)
  • Respiratory muscle endurance(eight week)
  • Pulmonary functions-FVC(eight week)
  • Pulmonary functions-FEF25-75(eight week)
  • Pulmonary functions-FEV1(eight week)
  • Pulmonary functions-FEV1/FVC(eight week)
  • Pulmonary functions-PEF(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)
  • squat 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)
  • balance(eight week)
  • static balance(eight week)
  • dynamic balance(eight week)
  • functional mobility(eight week)
  • Mcgill core endurance test(eight week)
  • Physical activity assessment(eight week)
  • Quality of life assessment(eight week)

Study Sites (1)

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