The Effect of Telerehabilitation on Functional Capacity, Oxidative Stress and Respiratory Parameters in Cystic Fibrosis

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cystic Fibrosis, Telerehabilitation

Intervention / Treatment
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* Other: stabilization exercises
* Other: combined exercises
* Other: Physical activity recommendations


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stabilization group<br>Only stabilization exercises in patients with cystic fibrosis | Other: stabilization exercises<br>* Patients will be applied only online supervised stabilization exercises three times a week for 8 weeks.<br>|
| Experimental: combined group<br>stabilization exercise and aerobic exercise training in patients with cystic fibrosis | Other: combined exercises<br>* Patients will be applied online supervised aerobic exercise training and stabilization exercises.Aerobic exercises will be performed for 8 weeks, for 30-45 minutes, at 65-75% of the maximum heart rate, 3 days a week, on the days when stabilization exercises are not performed.<br>|
| Experimental: control group<br>physical activity recommendations in patients with cystic fibrosis | Other: Physical activity recommendations<br>* The importance of physical activity will be explained to the patients and appropriate physical activity recommendations will be made.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| six minute walk test distance | Six-minute walk test distance is recorded | 10 minutes | 
| shuttle walk test distance | shuttle walk test distance is recorded | 15 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory muscle strength | Respiratory muscle strength will be evaluated using mouth pressure device | 10 minutes | 
| Respiratory muscle endurance | Respiratory muscle endurance will be evaluated using constant load test | 10 minutes | 
| Pulmonary functions | Forced vital capacity (FVC) assessment via spirometry | 15 minutes | 
| Pulmonary functions | FEV 1(f Forced expiratory volume at one second (FEV1) assessment via spirometry | 15 minutes | 
| Pulmonary functions | Peak expiratory flow (PEF) assessment via spirometry | 15 minutes | 
| Oxidative stress | Malondialdehyde (MDA), will be determined in the blood samples. | through study completion, an average of 5 month | 
| Oxidative stress | Carbonyl protein, will be determined in the blood samples. | through study completion, an average of 5 month | 
| Oxidative stress | Superoxide dismutase (SOD) will be determined in the blood samples | through study completion, an average of 5 month | 
| Oxidative stress | Catalase (CAT) will be determined in the blood samples | through study completion, an average of 5 month | 
| Oxidative stress | Total oxidant status (TOS) will be determined in the blood samples | through study completion, an average of 5 month | 
| Oxidative stress | Total antioxidant status (TAS) will be determined in the blood samples | through study completion, an average of 5 month | 
| Peripheral muscle strength | Peripheral muscle strength will be evaluated using dynamometer | 5 minutes | 
| crunch repetitions | number of crunch completed is recorded | 2 minutes | 
| squat repetitions | number of squats completed is recorded | 2 minutes | 
| push-up repetitions | number of push-ups completed is recorded | 2 minutes | 
| plank duration | duration of keeping plank position is recorded | 3 minutes | 
| 1 minute sit to stand test (STS) repetitions | number of sit to stand for one minute is recorded | 2 minutes | 
| myokine assessment | irisin levels will be determined in the blood sample | through study completion, an average of 5 month | 
| posture | Posture will be evaluated using Corbin Postural Assessment scale. Lateral and posterior views will be assessed (0 = absent, 1 = mild, 2 = moderate, 3 = severe) and posture score will be determined as excellent (0-2), very good (3-4), good (5-7), fair (8-11) and poor (>12). | 5 minutes | 
| posture | Thoracic kyphosis and lumbar lordosis angles will be evaluated in the sagittal plane with spinal mouse device. | 10 minutes | 
| balance | Pediatric berg balance scale will be used. The scale consists of 14 parts. Each section is scored between 0-4. The highest score that can be obtained from the scale is 56.Higher score means a better outcome. | 15 minutes | 
| static balance | static balance will be evaluated functional reach test | 2 minutes | 
| dynamic balance | Balance will be evaluated using one-legged standing test | 2 minutes | 
| functional mobility | functional mobility will be evaluated time-up go test | 2 minutes | 
| Mcgill core endurance test | Endurance of trunk muscles will be evaluated trunk flexor, trunk extensor and side plank test | 10 minutes | 
| Quality of life assessment | Quality of life will be evaluated using the Cystic Fibrosis Questionnaire-Revised (CFQ-R).The Cystic Fibrosis Questionnaire-Revised (CFQ-R) is a disease-specific health-related quality of life (HRQOL) measure for children, adolescents with cystic fibrosis (CF). The questionnaire assess physical functioning, emotional functioning, social functioning, body image, eating disorders, treatment, respiratory symptoms and digestive symptoms.Score range is 0-100. Higher scores indicating higher health-related quality of life. | 15 minutes | 
| Physical activity assessment | Physical activity levels will be assessed by The Physical Activity Questionnaire. Score range is 1-5. Higher scores indicating higher physical activity | 15 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exercise, oxidative stress, respiratory muscles