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

Cystic Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05147285
• Other study ID #: KA-20069
• Status: Completed
• Phase: N/A
• Start date: October 22, 2020
• Est. completion date: May 20, 2022

Study information

• Verified date: April 2024
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: May 20, 2022
• Est. primary completion date: May 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis
• Telerehabilitation

Intervention

Other:
• stabilization exercises
Patients will be applied only online supervised stabilization exercises three times a week for 8 weeks.
• combined 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.
• Physical activity recommendations
The importance of physical activity will be explained to the patients and appropriate physical activity recommendations will be made.

Locations

Country	Name	City	State
Turkey	Hacettepe University	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	six minute walk test distance	Six-minute walk test distance is recorded	before the exercise training
Primary	six minute walk test distance	Six-minute walk test distance is recorded	eight week
Primary	shuttle walk test distance	shuttle walk test distance is recorded	before exercise training
Primary	shuttle walk test distance	shuttle walk test distance is recorded	eight week
Secondary	Respiratory muscle strength	Respiratory muscle strength will be evaluated using mouth pressure device	before exercise training
Secondary	Respiratory muscle strength	Respiratory muscle strength will be evaluated using mouth pressure device	eight week
Secondary	Respiratory muscle endurance	Respiratory muscle endurance will be evaluated using constant load test	before exercise training
Secondary	Respiratory muscle endurance	Respiratory muscle endurance will be evaluated using constant load test	eight week
Secondary	Pulmonary functions-FVC	Forced vital capacity (FVC)	before exercise training
Secondary	Pulmonary functions-FVC	Forced vital capacity (FVC)	eight week
Secondary	Pulmonary functions-FEV1	Forced expiratory volume in the first second (FEV1)	before exercise training
Secondary	Pulmonary functions-FEV1	Forced expiratory volume in the first second (FEV1)	eight week
Secondary	Pulmonary functions-FEV1/FVC	FEV1/ FVC	before exercise training
Secondary	Pulmonary functions-FEV1/FVC	FEV1/ FVC	eight week
Secondary	Pulmonary functions-PEF	Peak Expiratory Flow (PEF)	before exercise training
Secondary	Pulmonary functions-PEF	Peak Expiratory Flow (PEF)	eight week
Secondary	Pulmonary functions-FEF25-75	Forced mid-expiratory flow (FEF25-75)	before exercise training
Secondary	Pulmonary functions-FEF25-75	Forced mid-expiratory flow (FEF25-75)	eight week
Secondary	Oxidative stress-MDA	Malondialdehyde (MDA) will be determined in the blood samples.	before exercise training
Secondary	Oxidative stress-MDA	Malondialdehyde (MDA) will be determined in the blood samples.	eight week
Secondary	Oxidative stress-SOD	Superoxide dismutase (SOD) will be determined in the blood samples.	before exercise training
Secondary	Oxidative stress-SOD	Superoxide dismutase (SOD) will be determined in the blood samples.	eight week
Secondary	Oxidative stress-CAT	Catalase (CAT) will be determined in the blood samples.	before exercise training
Secondary	Oxidative stress-CAT	Catalase (CAT) will be determined in the blood samples.	eight week
Secondary	Oxidative stress-PC	Protein carbonyl (PC) will be determined in the blood samples.	before exercise training
Secondary	Oxidative stress-PC	Protein carbonyl (PC) will be determined in the blood samples.	eight week
Secondary	Oxidative stress-TOS	Total oxidant status (TOS) will be determined in the blood samples.	before exercise training
Secondary	Oxidative stress-TOS	Total oxidant status (TOS) will be determined in the blood samples.	eight week
Secondary	Oxidative stress-TAS	Total antioxidant status(TAS) will be determined in the blood samples.	before exercise training
Secondary	Oxidative stress-TAS	Total antioxidant status (TAS) will be determined in the blood samples.	eight week
Secondary	Oxidative stress-oxidative stress index	Oxidative stress index (TOS/TAS)	before exercise training
Secondary	Oxidative stress-oxidative stress index	Oxidative stress index (TOS/TAS)	eight week
Secondary	Peripheral muscle strength	Peripheral muscle strength will be evaluated using dynamometer	before exercise training
Secondary	Peripheral muscle strength	Peripheral muscle strength will be evaluated using dynamometer	eight week
Secondary	crunch repetitions	number of crunch completed is recorded	before exercise training
Secondary	crunch repetitions	number of crunch completed is recorded	eight week
Secondary	squat repetitions	number of squats completed is recorded	before exercise training
Secondary	squat repetitions	number of squats completed is recorded	eight week
Secondary	push-up repetitions	number of push-ups completed is recorded	before exercise training
Secondary	push-up repetitions	number of push-ups completed is recorded	eight week
Secondary	plank duration	duration of keeping plank position is recorded	before exercise training
Secondary	plank duration	duration of keeping plank position is recorded	eight week
Secondary	1 minute sit to stand test (STS) repetitions	number of sit to stand for one minute is recorded	before exercise training
Secondary	1 minute sit to stand test (STS) repetitions	number of sit to stand for one minute is recorded	eight week
Secondary	myokine assessment	irisin levels will be determined in the blood sample	before exercise training
Secondary	myokine assessment	irisin levels will be determined in the blood sample	eight week
Secondary	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
Secondary	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
Secondary	posture	Thoracic kyphosis and lumbar lordosis angles will be evaluated in the sagittal plane with spinal mouse device.	before exercise training
Secondary	posture	Thoracic kyphosis and lumbar lordosis angles will be evaluated in the sagittal plane with spinal mouse device.	eight week
Secondary	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
Secondary	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
Secondary	static balance	static balance will be evaluated functional reach test	before exercise training
Secondary	static balance	static balance will be evaluated functional reach test	eight week
Secondary	dynamic balance	Balance will be evaluated using one-legged standing test	before exercise training
Secondary	dynamic balance	Balance will be evaluated using one-legged standing test	eight week
Secondary	functional mobility	functional mobility will be evaluated time-up go test	before exercise training
Secondary	functional mobility	functional mobility will be evaluated time-up go test	eight week
Secondary	Mcgill core endurance test	Endurance of trunk muscles will be evaluated trunk flexor, trunk extensor and side plank test	before exercise training
Secondary	Mcgill core endurance test	Endurance of trunk muscles will be evaluated trunk flexor, trunk extensor and side plank test	eight week
Secondary	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
Secondary	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
Secondary	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
Secondary	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