Cystic Fibrosis, Telerehabilitation
Conditions
Keywords
exercise, oxidative stress, respiratory muscles
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.
Interventions
Patients will be applied only online supervised stabilization exercises three times a week for 8 weeks.
OTHERcombined exercises
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.
Sponsors
Hacettepe University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
8 Years to 18 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| six minute walk test distance | before the exercise training | Six-minute walk test distance is recorded |
| shuttle walk test distance | before exercise training | shuttle walk test distance is recorded |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pulmonary functions-FVC | before exercise training | Forced vital capacity (FVC) |
| Pulmonary functions-FEV1 | before exercise training | Forced expiratory volume in the first second (FEV1) |
| Pulmonary functions-FEV1/FVC | before exercise training | FEV1/ FVC |
| Pulmonary functions-PEF | before exercise training | Peak Expiratory Flow (PEF) |
| Pulmonary functions-FEF25-75 | before exercise training | Forced mid-expiratory flow (FEF25-75) |
| Oxidative stress-MDA | before exercise training | Malondialdehyde (MDA) will be determined in the blood samples. |
| Oxidative stress-SOD | before exercise training | Superoxide dismutase (SOD) will be determined in the blood samples. |
| Oxidative stress-CAT | before exercise training | Catalase (CAT) will be determined in the blood samples. |
| Oxidative stress-PC | before exercise training | Protein carbonyl (PC) will be determined in the blood samples. |
| Oxidative stress-TOS | before exercise training | Total oxidant status (TOS) will be determined in the blood samples. |
| Oxidative stress-TAS | before exercise training | Total antioxidant status(TAS) will be determined in the blood samples. |
| Oxidative stress-oxidative stress index | before exercise training | Oxidative stress index (TOS/TAS) |
| Peripheral muscle strength | before exercise training | Peripheral muscle strength will be evaluated using dynamometer |
| crunch repetitions | before exercise training | number of crunch completed is recorded |
| Respiratory muscle strength | before exercise training | Respiratory muscle strength will be evaluated using mouth pressure device |
| push-up repetitions | before exercise training | number of push-ups completed is recorded |
| plank duration | before exercise training | duration of keeping plank position is recorded |
| 1 minute sit to stand test (STS) repetitions | before exercise training | number of sit to stand for one minute is recorded |
| myokine assessment | before exercise training | irisin levels will be determined in the blood sample |
| posture-Corbin | before exercise training | 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). |
| posture | before exercise training | Thoracic kyphosis and lumbar lordosis angles will be evaluated in the sagittal plane with spinal mouse device. |
| balance | before exercise training | 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. |
| static balance | before exercise training | static balance will be evaluated functional reach test |
| dynamic balance | before exercise training | Balance will be evaluated using one-legged standing test |
| functional mobility | before exercise training | functional mobility will be evaluated time-up go test |
| Mcgill core endurance test | before exercise training | Endurance of trunk muscles will be evaluated trunk flexor, trunk extensor and side plank test |
| Quality of life assessment | before exercise training | 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. |
| Physical activity assessment | before exercise training | Physical activity levels will be assessed by The Physical Activity Questionnaire. Score range is 1-5. Higher scores indicating higher physical activity |
| squat repetitions | before exercise training | number of squats completed is recorded |
| Respiratory muscle endurance | before exercise training | Respiratory muscle endurance will be evaluated using constant load test |
Countries
Turkey (Türkiye)
Outcome results
None listed