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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stabilization group | Experimental | Only stabilization exercises in patients with cystic fibrosis |
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| combined group | Experimental | stabilization exercise and aerobic exercise training in patients with cystic fibrosis |
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| control group | Experimental | physical activity recommendations in patients with cystic fibrosis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| stabilization exercises | Other | Patients will be applied only online supervised stabilization exercises three times a week for 8 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| six minute walk test distance | Six-minute walk test distance is recorded | before the exercise training |
| six minute walk test distance | Six-minute walk test distance is recorded | eight week |
| shuttle walk test distance | shuttle walk test distance is recorded | before exercise training |
| shuttle walk test distance | shuttle walk test distance is recorded | eight week |
| Measure | Description | Time Frame |
|---|---|---|
| Respiratory muscle strength | Respiratory muscle strength will be evaluated using mouth pressure device | before exercise training |
| Respiratory muscle strength | Respiratory muscle strength will be evaluated using mouth pressure device |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Deniz Dogru-Ersoz, Professor | Hacettepe University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hacettepe University | Ankara | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38981171 | Derived | Kilic K, Vardar-Yagli N, Nayir-Buyuksahin H, Guzelkas I, Dogru D, Saglam M, Calik-Kutukcu E, Inal-Ince D, Emiralioglu N, Yalcin E, Ozcelik U, Kiper N. Exercise intolerance, oxidative stress, and irisin in pediatric cystic fibrosis: Can telehealth-based exercise training make a difference? Heart Lung. 2024 Nov-Dec;68:145-153. doi: 10.1016/j.hrtlng.2024.06.016. Epub 2024 Jul 8. |
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| combined exercises | Other | 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. |
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| Physical activity recommendations | Other | The importance of physical activity will be explained to the patients and appropriate physical activity recommendations will be made. |
|
| eight week |
| Respiratory muscle endurance | Respiratory muscle endurance will be evaluated using constant load test | before exercise training |
| Respiratory muscle endurance | Respiratory muscle endurance will be evaluated using constant load test | eight week |
| Pulmonary functions-FVC | Forced vital capacity (FVC) | before exercise training |
| Pulmonary functions-FVC | Forced vital capacity (FVC) | eight week |
| Pulmonary functions-FEV1 | Forced expiratory volume in the first second (FEV1) | before exercise training |
| Pulmonary functions-FEV1 | Forced expiratory volume in the first second (FEV1) | eight week |
| Pulmonary functions-FEV1/FVC | FEV1/ FVC | before exercise training |
| Pulmonary functions-FEV1/FVC | FEV1/ FVC | eight week |
| Pulmonary functions-PEF | Peak Expiratory Flow (PEF) | before exercise training |
| Pulmonary functions-PEF | Peak Expiratory Flow (PEF) | eight week |
| Pulmonary functions-FEF25-75 | Forced mid-expiratory flow (FEF25-75) | before exercise training |
| Pulmonary functions-FEF25-75 | Forced mid-expiratory flow (FEF25-75) | eight week |
| Oxidative stress-MDA | Malondialdehyde (MDA) will be determined in the blood samples. | before exercise training |
| Oxidative stress-MDA | Malondialdehyde (MDA) will be determined in the blood samples. | eight week |
| Oxidative stress-SOD | Superoxide dismutase (SOD) will be determined in the blood samples. | before exercise training |
| Oxidative stress-SOD | Superoxide dismutase (SOD) will be determined in the blood samples. | eight week |
| Oxidative stress-CAT | Catalase (CAT) will be determined in the blood samples. | before exercise training |
| Oxidative stress-CAT | Catalase (CAT) will be determined in the blood samples. | eight week |
| Oxidative stress-PC | Protein carbonyl (PC) will be determined in the blood samples. | before exercise training |
| Oxidative stress-PC | Protein carbonyl (PC) will be determined in the blood samples. | eight week |
| Oxidative stress-TOS | Total oxidant status (TOS) will be determined in the blood samples. | before exercise training |
| Oxidative stress-TOS | Total oxidant status (TOS) will be determined in the blood samples. | eight week |
| Oxidative stress-TAS | Total antioxidant status(TAS) will be determined in the blood samples. | before exercise training |
| Oxidative stress-TAS | Total antioxidant status (TAS) will be determined in the blood samples. | eight week |
| Oxidative stress-oxidative stress index | Oxidative stress index (TOS/TAS) | before exercise training |
| Oxidative stress-oxidative stress index | Oxidative stress index (TOS/TAS) | eight week |
| Peripheral muscle strength | Peripheral muscle strength will be evaluated using dynamometer | before exercise training |
| Peripheral muscle strength | Peripheral muscle strength will be evaluated using dynamometer | eight week |
| crunch repetitions | number of crunch completed is recorded | before exercise training |
| crunch repetitions | number of crunch completed is recorded | eight week |
| squat repetitions | number of squats completed is recorded | before exercise training |
| squat repetitions | number of squats completed is recorded | eight week |
| push-up repetitions | number of push-ups completed is recorded | before exercise training |
| push-up repetitions | number of push-ups completed is recorded | eight week |
| plank duration | duration of keeping plank position is recorded | before exercise training |
| plank duration | duration of keeping plank position is recorded | eight week |
| 1 minute sit to stand test (STS) repetitions | number of sit to stand for one minute is recorded | before exercise training |
| 1 minute sit to stand test (STS) repetitions | number of sit to stand for one minute is recorded | eight week |
| myokine assessment | irisin levels will be determined in the blood sample | before exercise training |
| myokine assessment | irisin levels will be determined in the blood sample | eight week |
| posture-Corbin | 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). | before exercise training |
| posture-Corbin | 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). | eight week |
| posture | Thoracic kyphosis and lumbar lordosis angles will be evaluated in the sagittal plane with spinal mouse device. | before exercise training |
| posture | Thoracic kyphosis and lumbar lordosis angles will be evaluated in the sagittal plane with spinal mouse device. | eight week |
| 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. | before exercise training |
| 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. | eight week |
| static balance | static balance will be evaluated functional reach test | before exercise training |
| static balance | static balance will be evaluated functional reach test | eight week |
| dynamic balance | Balance will be evaluated using one-legged standing test | before exercise training |
| dynamic balance | Balance will be evaluated using one-legged standing test | eight week |
| functional mobility | functional mobility will be evaluated time-up go test | before exercise training |
| functional mobility | functional mobility will be evaluated time-up go test | eight week |
| Mcgill core endurance test | Endurance of trunk muscles will be evaluated trunk flexor, trunk extensor and side plank test | before exercise training |
| Mcgill core endurance test | Endurance of trunk muscles will be evaluated trunk flexor, trunk extensor and side plank test | eight week |
| 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. | before exercise training |
| 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. | eight week |
| 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 | before exercise training |
| 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 | eight week |
| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
| D001519 | Behavior |
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