Clinical trial NCT05147285: The Effect of Telerehabilitation on Functional Capacity, Oxidative Stress and Respiratory Parameters in Cystic Fibrosis
Official title: The Effect of Different Exercise Modalities Applied by Tele Rehabilitation on Functional Capacity, Oxidative Stress and Respiratory Parameters in Cystic Fibrosis Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Telerehabilitation
Keywords: exercise
oxidative stress
respiratory muscles
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2021-12-07
Enrollment: 39
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: six minute walk test distance
timeFrame: before the exercise training
measure: six minute walk test distance
timeFrame: eight week
measure: shuttle walk test distance
timeFrame: before exercise training
measure: shuttle walk test distance
timeFrame: eight week
Secondary outcomes:
measure: Respiratory muscle strength
timeFrame: before exercise training
measure: Respiratory muscle strength
timeFrame: eight week
measure: Respiratory muscle endurance
timeFrame: before exercise training
measure: Respiratory muscle endurance
timeFrame: eight week
measure: Pulmonary functions-FVC
timeFrame: before exercise training
measure: Pulmonary functions-FVC
timeFrame: eight week
measure: Pulmonary functions-FEV1
timeFrame: before exercise training
measure: Pulmonary functions-FEV1
timeFrame: eight week
measure: Pulmonary functions-FEV1/FVC
timeFrame: before exercise training
measure: Pulmonary functions-FEV1/FVC
timeFrame: eight week
measure: Pulmonary functions-PEF
timeFrame: before exercise training
measure: Pulmonary functions-PEF
timeFrame: eight week
measure: Pulmonary functions-FEF25-75
timeFrame: before exercise training
measure: Pulmonary functions-FEF25-75
timeFrame: eight week
measure: Oxidative stress-MDA
timeFrame: before exercise training
measure: Oxidative stress-MDA
timeFrame: eight week
measure: Oxidative stress-SOD
timeFrame: before exercise training
measure: Oxidative stress-SOD
timeFrame: eight week
measure: Oxidative stress-CAT
timeFrame: before exercise training
measure: Oxidative stress-CAT
timeFrame: eight week
measure: Oxidative stress-PC
timeFrame: before exercise training
measure: Oxidative stress-PC
timeFrame: eight week
measure: Oxidative stress-TOS
timeFrame: before exercise training
measure: Oxidative stress-TOS
timeFrame: eight week
measure: Oxidative stress-TAS
timeFrame: before exercise training
measure: Oxidative stress-TAS
timeFrame: eight week
measure: Oxidative stress-oxidative stress index
timeFrame: before exercise training
measure: Oxidative stress-oxidative stress index
timeFrame: eight week
measure: Peripheral muscle strength
timeFrame: before exercise training
measure: Peripheral muscle strength
timeFrame: eight week
measure: crunch repetitions
timeFrame: before exercise training
measure: crunch repetitions
timeFrame: eight week
measure: squat repetitions
timeFrame: before exercise training
measure: squat repetitions
timeFrame: eight week
measure: push-up repetitions
timeFrame: before exercise training
measure: push-up repetitions
timeFrame: eight week
measure: plank duration
timeFrame: before exercise training
measure: plank duration
timeFrame: eight week
measure: 1 minute sit to stand test (STS) repetitions
timeFrame: before exercise training
measure: 1 minute sit to stand test (STS) repetitions
timeFrame: eight week
measure: myokine assessment
timeFrame: before exercise training
measure: myokine assessment
timeFrame: eight week
measure: posture-Corbin
timeFrame: before exercise training
measure: posture-Corbin
timeFrame: eight week
measure: posture
timeFrame: before exercise training
measure: posture
timeFrame: eight week
measure: balance
timeFrame: before exercise training
measure: balance
timeFrame: eight week
measure: static balance
timeFrame: before exercise training
measure: static balance
timeFrame: eight week
measure: dynamic balance
timeFrame: before exercise training
measure: dynamic balance
timeFrame: eight week
measure: functional mobility
timeFrame: before exercise training
measure: functional mobility
timeFrame: eight week
measure: Mcgill core endurance test
timeFrame: before exercise training
measure: Mcgill core endurance test
timeFrame: eight week
measure: Quality of life assessment
timeFrame: before exercise training
measure: Quality of life assessment
timeFrame: eight week
measure: Physical activity assessment
timeFrame: before exercise training
measure: Physical activity assessment
timeFrame: eight week
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
affiliation: Hacettepe University
name: Deniz Dogru-Ersoz, Professor
role: PRINCIPAL_INVESTIGATOR
References: