An interventional study of stabilization exercises and combined exercises in Cystic Fibrosis and Telerehabilitation, sponsored by Hacettepe University. Completed at 1 site in Turkey. Open to participants aged 8 Years to 18 Years. Per ClinicalTrials.gov, last updated 2024-04-25.
Sponsored by Hacettepe University · Not applicable, Interventional, and Treatment
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.
1,581 studies on the registry are indexed under Cystic Fibrosis; 190 are open to participants now.
This study's enrollment of 39 is close to the median of 36 across 1,034 interventional studies indexed under Cystic Fibrosis.
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Exclusion Criteria:
Only stabilization exercises in patients with cystic fibrosis
Other: stabilization exercises
stabilization exercise and aerobic exercise training in patients with cystic fibrosis
Other: combined exercises
physical activity recommendations in patients with cystic fibrosis
Other: Physical activity recommendations
Patients will be applied only online supervised stabilization exercises three times a week for 8 weeks.
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.
The importance of physical activity will be explained to the patients and appropriate physical activity recommendations will be made.
six minute walk test distance
Six-minute walk test distance is recorded
Time frame: before the exercise training
six minute walk test distance
Six-minute walk test distance is recorded
Time frame: eight week
shuttle walk test distance
shuttle walk test distance is recorded
Time frame: before exercise training
shuttle walk test distance
shuttle walk test distance is recorded
Time frame: eight week
Respiratory muscle strength
Respiratory muscle strength will be evaluated using mouth pressure device
Time frame: before exercise training
Respiratory muscle strength
Respiratory muscle strength will be evaluated using mouth pressure device
Time frame: eight week
Respiratory muscle endurance
Respiratory muscle endurance will be evaluated using constant load test
Time frame: before exercise training
Respiratory muscle endurance
Respiratory muscle endurance will be evaluated using constant load test
Time frame: eight week
Pulmonary functions-FVC
Forced vital capacity (FVC)
Time frame: before exercise training
Pulmonary functions-FVC
Forced vital capacity (FVC)
Time frame: eight week
Pulmonary functions-FEV1
Forced expiratory volume in the first second (FEV1)
Time frame: before exercise training
Pulmonary functions-FEV1
Forced expiratory volume in the first second (FEV1)
Time frame: eight week
Pulmonary functions-FEV1/FVC
FEV1/ FVC
Time frame: before exercise training
Pulmonary functions-FEV1/FVC
FEV1/ FVC
Time frame: eight week
Pulmonary functions-PEF
Peak Expiratory Flow (PEF)
Time frame: before exercise training
Pulmonary functions-PEF
Peak Expiratory Flow (PEF)
Time frame: eight week
Pulmonary functions-FEF25-75
Forced mid-expiratory flow (FEF25-75)
Time frame: before exercise training
Pulmonary functions-FEF25-75
Forced mid-expiratory flow (FEF25-75)
Time frame: eight week
Oxidative stress-MDA
Malondialdehyde (MDA) will be determined in the blood samples.
Time frame: before exercise training
Oxidative stress-MDA
Malondialdehyde (MDA) will be determined in the blood samples.
Time frame: eight week
Oxidative stress-SOD
Superoxide dismutase (SOD) will be determined in the blood samples.
Time frame: before exercise training
Oxidative stress-SOD
Superoxide dismutase (SOD) will be determined in the blood samples.
Time frame: eight week
Oxidative stress-CAT
Catalase (CAT) will be determined in the blood samples.
Time frame: before exercise training
Oxidative stress-CAT
Catalase (CAT) will be determined in the blood samples.
Time frame: eight week
Oxidative stress-PC
Protein carbonyl (PC) will be determined in the blood samples.
Time frame: before exercise training
Oxidative stress-PC
Protein carbonyl (PC) will be determined in the blood samples.
Time frame: eight week
Oxidative stress-TOS
Total oxidant status (TOS) will be determined in the blood samples.
Time frame: before exercise training
Oxidative stress-TOS
Total oxidant status (TOS) will be determined in the blood samples.
Time frame: eight week
Oxidative stress-TAS
Total antioxidant status(TAS) will be determined in the blood samples.
Time frame: before exercise training
Oxidative stress-TAS
Total antioxidant status (TAS) will be determined in the blood samples.
Time frame: eight week
Oxidative stress-oxidative stress index
Oxidative stress index (TOS/TAS)
Time frame: before exercise training
Oxidative stress-oxidative stress index
Oxidative stress index (TOS/TAS)
Time frame: eight week
Peripheral muscle strength
Peripheral muscle strength will be evaluated using dynamometer
Time frame: before exercise training
Peripheral muscle strength
Peripheral muscle strength will be evaluated using dynamometer
Time frame: eight week
crunch repetitions
number of crunch completed is recorded
Time frame: before exercise training
crunch repetitions
number of crunch completed is recorded
Time frame: eight week
squat repetitions
number of squats completed is recorded
Time frame: before exercise training
squat repetitions
number of squats completed is recorded
Time frame: eight week
push-up repetitions
number of push-ups completed is recorded
Time frame: before exercise training
push-up repetitions
number of push-ups completed is recorded
Time frame: eight week
plank duration
duration of keeping plank position is recorded
Time frame: before exercise training
plank duration
duration of keeping plank position is recorded
Time frame: eight week
1 minute sit to stand test (STS) repetitions
number of sit to stand for one minute is recorded
Time frame: before exercise training
1 minute sit to stand test (STS) repetitions
number of sit to stand for one minute is recorded
Time frame: eight week
myokine assessment
irisin levels will be determined in the blood sample
Time frame: before exercise training
myokine assessment
irisin levels will be determined in the blood sample
Time frame: 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).
Time frame: 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).
Time frame: eight week
posture
Thoracic kyphosis and lumbar lordosis angles will be evaluated in the sagittal plane with spinal mouse device.
Time frame: before exercise training
posture
Thoracic kyphosis and lumbar lordosis angles will be evaluated in the sagittal plane with spinal mouse device.
Time frame: 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.
Time frame: 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.
Time frame: eight week
static balance
static balance will be evaluated functional reach test
Time frame: before exercise training
static balance
static balance will be evaluated functional reach test
Time frame: eight week
dynamic balance
Balance will be evaluated using one-legged standing test
Time frame: before exercise training
dynamic balance
Balance will be evaluated using one-legged standing test
Time frame: eight week
functional mobility
functional mobility will be evaluated time-up go test
Time frame: before exercise training
functional mobility
functional mobility will be evaluated time-up go test
Time frame: eight week
Mcgill core endurance test
Endurance of trunk muscles will be evaluated trunk flexor, trunk extensor and side plank test
Time frame: before exercise training
Mcgill core endurance test
Endurance of trunk muscles will be evaluated trunk flexor, trunk extensor and side plank test
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: eight week
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Hacettepe University