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NCT Number: NCT05147285

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

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

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Key information

Conditions

Cystic Fibrosis Behavior Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Motor Activity Pancreatic Diseases Respiratory Tract Diseases Telerehabilitation

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hacettepe University

Ankara, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Stabilization Exercises

Other

Patients will be applied only online supervised stabilization exercises three times a week for 8 weeks.

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.

Physical activity recommendations

Other

The importance of physical activity will be explained to the patients and appropriate physical activity recommendations will be made.

Primary outcomes

  1. six minute walk test distance

    Time frame: before the exercise training

    Six-minute walk test distance is recorded

  2. six minute walk test distance

    Time frame: eight week

    Six-minute walk test distance is recorded

  3. shuttle walk test distance

    Time frame: before exercise training

    shuttle walk test distance is recorded

  4. shuttle walk test distance

    Time frame: eight week

    shuttle walk test distance is recorded

Secondary outcomes

  1. Respiratory muscle strength

    Time frame: before exercise training

    Respiratory muscle strength will be evaluated using mouth pressure device

  2. Respiratory muscle strength

    Time frame: eight week

    Respiratory muscle strength will be evaluated using mouth pressure device

  3. Respiratory muscle endurance

    Time frame: before exercise training

    Respiratory muscle endurance will be evaluated using constant load test

  4. Respiratory muscle endurance

    Time frame: eight week

    Respiratory muscle endurance will be evaluated using constant load test

  5. Pulmonary functions-FVC

    Time frame: before exercise training

    Forced vital capacity (FVC)

  6. Pulmonary functions-FVC

    Time frame: eight week

    Forced vital capacity (FVC)

  7. Pulmonary functions-FEV1

    Time frame: before exercise training

    Forced expiratory volume in the first second (FEV1)

  8. Pulmonary functions-FEV1

    Time frame: eight week

    Forced expiratory volume in the first second (FEV1)

  9. Pulmonary functions-FEV1/FVC

    Time frame: before exercise training

    FEV1/ FVC

  10. Pulmonary functions-FEV1/FVC

    Time frame: eight week

    FEV1/ FVC

  11. Pulmonary functions-PEF

    Time frame: before exercise training

    Peak Expiratory Flow (PEF)

  12. Pulmonary functions-PEF

    Time frame: eight week

    Peak Expiratory Flow (PEF)

  13. Pulmonary functions-FEF25-75

    Time frame: before exercise training

    Forced mid-expiratory flow (FEF25-75)

  14. Pulmonary functions-FEF25-75

    Time frame: eight week

    Forced mid-expiratory flow (FEF25-75)

  15. Oxidative stress-MDA

    Time frame: before exercise training

    Malondialdehyde (MDA) will be determined in the blood samples.

  16. Oxidative stress-MDA

    Time frame: eight week

    Malondialdehyde (MDA) will be determined in the blood samples.

  17. Oxidative stress-SOD

    Time frame: before exercise training

    Superoxide dismutase (SOD) will be determined in the blood samples.

  18. Oxidative stress-SOD

    Time frame: eight week

    Superoxide dismutase (SOD) will be determined in the blood samples.

  19. Oxidative stress-CAT

    Time frame: before exercise training

    Catalase (CAT) will be determined in the blood samples.

  20. Oxidative stress-CAT

    Time frame: eight week

    Catalase (CAT) will be determined in the blood samples.

  21. Oxidative stress-PC

    Time frame: before exercise training

    Protein carbonyl (PC) will be determined in the blood samples.

  22. Oxidative stress-PC

    Time frame: eight week

    Protein carbonyl (PC) will be determined in the blood samples.

  23. Oxidative stress-TOS

    Time frame: before exercise training

    Total oxidant status (TOS) will be determined in the blood samples.

  24. Oxidative stress-TOS

    Time frame: eight week

    Total oxidant status (TOS) will be determined in the blood samples.

  25. Oxidative stress-TAS

    Time frame: before exercise training

    Total antioxidant status(TAS) will be determined in the blood samples.

  26. Oxidative stress-TAS

    Time frame: eight week

    Total antioxidant status (TAS) will be determined in the blood samples.

  27. Oxidative stress-oxidative stress index

    Time frame: before exercise training

    Oxidative stress index (TOS/TAS)

  28. Oxidative stress-oxidative stress index

    Time frame: eight week

    Oxidative stress index (TOS/TAS)

  29. Peripheral muscle strength

    Time frame: before exercise training

    Peripheral muscle strength will be evaluated using dynamometer

  30. Peripheral muscle strength

    Time frame: eight week

    Peripheral muscle strength will be evaluated using dynamometer

  31. crunch repetitions

    Time frame: before exercise training

    number of crunch completed is recorded

  32. crunch repetitions

    Time frame: eight week

    number of crunch completed is recorded

  33. squat repetitions

    Time frame: before exercise training

    number of squats completed is recorded

  34. squat repetitions

    Time frame: eight week

    number of squats completed is recorded

  35. push-up repetitions

    Time frame: before exercise training

    number of push-ups completed is recorded

  36. push-up repetitions

    Time frame: eight week

    number of push-ups completed is recorded

  37. plank duration

    Time frame: before exercise training

    duration of keeping plank position is recorded

  38. plank duration

    Time frame: eight week

    duration of keeping plank position is recorded

  39. 1 minute sit to stand test (STS) repetitions

    Time frame: before exercise training

    number of sit to stand for one minute is recorded

  40. 1 minute sit to stand test (STS) repetitions

    Time frame: eight week

    number of sit to stand for one minute is recorded

  41. myokine assessment

    Time frame: before exercise training

    irisin levels will be determined in the blood sample

  42. myokine assessment

    Time frame: eight week

    irisin levels will be determined in the blood sample

  43. posture-Corbin

    Time frame: 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).

  44. posture-Corbin

    Time frame: eight week

    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).

  45. posture

    Time frame: before exercise training

    Thoracic kyphosis and lumbar lordosis angles will be evaluated in the sagittal plane with spinal mouse device.

  46. posture

    Time frame: eight week

    Thoracic kyphosis and lumbar lordosis angles will be evaluated in the sagittal plane with spinal mouse device.

  47. balance

    Time frame: 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.

  48. balance

    Time frame: eight week

    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.

  49. static balance

    Time frame: before exercise training

    static balance will be evaluated functional reach test

  50. static balance

    Time frame: eight week

    static balance will be evaluated functional reach test

  51. dynamic balance

    Time frame: before exercise training

    Balance will be evaluated using one-legged standing test

  52. dynamic balance

    Time frame: eight week

    Balance will be evaluated using one-legged standing test

  53. functional mobility

    Time frame: before exercise training

    functional mobility will be evaluated time-up go test

  54. functional mobility

    Time frame: eight week

    functional mobility will be evaluated time-up go test

  55. Mcgill core endurance test

    Time frame: before exercise training

    Endurance of trunk muscles will be evaluated trunk flexor, trunk extensor and side plank test

  56. Mcgill core endurance test

    Time frame: eight week

    Endurance of trunk muscles will be evaluated trunk flexor, trunk extensor and side plank test

  57. Quality of life assessment

    Time frame: 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.

  58. Quality of life assessment

    Time frame: eight week

    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.

  59. Physical activity assessment

    Time frame: 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

  60. Physical activity assessment

    Time frame: eight week

    Physical activity levels will be assessed by The Physical Activity Questionnaire. Score range is 1-5. Higher scores indicating higher physical activity

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Dec 7, 2021
Registry last updated
Apr 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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