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

Not Applicable

Completed

• Conditions: Telerehabilitation; Cystic Fibrosis
• Interventions: Other: Physical activity recommendations; Other: stabilization exercises; Other: combined exercises

• Registration Number: NCT05147285
• Lead Sponsor: Hacettepe University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-10-22
• Study First Submitted: 2021-10-31
• Study First Submitted QC: 2021-11-24
• Study First Posted: 2021-12-07
• Primary Completion: 2022-05-20
• Study Completion: 2022-05-20
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-23
• Last Update Posted: 2024-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	Physical activity recommendations	physical activity recommendations in patients with cystic fibrosis
Stabilization group	stabilization exercises	Only stabilization exercises in patients with cystic fibrosis
combined group	combined exercises	stabilization exercise and aerobic exercise training in patients with cystic fibrosis

Primary Outcome Measures

Name	Time	Method
six minute walk test distance	eight week	Six-minute walk test distance is recorded
shuttle walk test distance	eight week	shuttle walk test distance is recorded

Secondary Outcome Measures

Name	Time	Method
Oxidative stress-TAS	eight week	Total antioxidant status (TAS) will be determined in the blood samples.
Pulmonary functions-FEV1	eight week	Forced expiratory volume in the first second (FEV1)
Pulmonary functions-FEV1/FVC	eight week	FEV1/ FVC
Respiratory muscle strength	eight week	Respiratory muscle strength will be evaluated using mouth pressure device
Respiratory muscle endurance	eight week	Respiratory muscle endurance will be evaluated using constant load test
Pulmonary functions-FVC	eight week	Forced vital capacity (FVC)
Pulmonary functions-FEF25-75	eight week	Forced mid-expiratory flow (FEF25-75)
Pulmonary functions-PEF	eight week	Peak Expiratory Flow (PEF)
Oxidative stress-MDA	eight week	Malondialdehyde (MDA) will be determined in the blood samples.
Oxidative stress-SOD	eight week	Superoxide dismutase (SOD) will be determined in the blood samples.
Oxidative stress-CAT	eight week	Catalase (CAT) will be determined in the blood samples.
Oxidative stress-PC	eight week	Protein carbonyl (PC) will be determined in the blood samples.
Oxidative stress-TOS	eight week	Total oxidant status (TOS) will be determined in the blood samples.
Oxidative stress-oxidative stress index	eight week	Oxidative stress index (TOS/TAS)
Peripheral muscle strength	eight week	Peripheral muscle strength will be evaluated using dynamometer
crunch repetitions	eight week	number of crunch completed is recorded
squat repetitions	eight week	number of squats completed is recorded
push-up repetitions	eight week	number of push-ups completed is recorded
plank duration	eight week	duration of keeping plank position is recorded
1 minute sit to stand test (STS) repetitions	eight week	number of sit to stand for one minute is recorded
myokine assessment	eight week	irisin levels will be determined in the blood sample
posture-Corbin	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).
posture	eight week	Thoracic kyphosis and lumbar lordosis angles will be evaluated in the sagittal plane with spinal mouse device.
balance	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.
static balance	eight week	static balance will be evaluated functional reach test
dynamic balance	eight week	Balance will be evaluated using one-legged standing test
functional mobility	eight week	functional mobility will be evaluated time-up go test
Mcgill core endurance test	eight week	Endurance of trunk muscles will be evaluated trunk flexor, trunk extensor and side plank test
Physical activity assessment	eight week	Physical activity levels will be assessed by The Physical Activity Questionnaire. Score range is 1-5. Higher scores indicating higher physical activity
Quality of life assessment	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.

Trial Locations

Locations (1)

Hacettepe University; 🇹🇷 Ankara, Turkey