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

Primary Purpose

Cystic Fibrosis, Telerehabilitation

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
stabilization exercises
combined exercises
Physical activity recommendations
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystic Fibrosis focused on measuring exercise, oxidative stress, respiratory muscles

Eligibility Criteria

8 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hacettepe UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Stabilization group

combined group

control group

Arm Description

Only stabilization exercises in patients with cystic fibrosis

stabilization exercise and aerobic exercise training in patients with cystic fibrosis

physical activity recommendations in patients with cystic fibrosis

Outcomes

Primary Outcome Measures

six minute walk test distance
Six-minute walk test distance is recorded
shuttle walk test distance
shuttle walk test distance is recorded

Secondary Outcome Measures

Respiratory muscle strength
Respiratory muscle strength will be evaluated using mouth pressure device
Respiratory muscle endurance
Respiratory muscle endurance will be evaluated using constant load test
Pulmonary functions
Forced vital capacity (FVC) assessment via spirometry
Pulmonary functions
FEV 1(f Forced expiratory volume at one second (FEV1) assessment via spirometry
Pulmonary functions
Peak expiratory flow (PEF) assessment via spirometry
Oxidative stress
Malondialdehyde (MDA), will be determined in the blood samples.
Oxidative stress
Carbonyl protein, will be determined in the blood samples.
Oxidative stress
Superoxide dismutase (SOD) will be determined in the blood samples
Oxidative stress
Catalase (CAT) will be determined in the blood samples
Oxidative stress
Total oxidant status (TOS) will be determined in the blood samples
Oxidative stress
Total antioxidant status (TAS) will be determined in the blood samples
Peripheral muscle strength
Peripheral muscle strength will be evaluated using dynamometer
crunch repetitions
number of crunch completed is recorded
squat repetitions
number of squats completed is recorded
push-up repetitions
number of push-ups completed is recorded
plank duration
duration of keeping plank position is recorded
1 minute sit to stand test (STS) repetitions
number of sit to stand for one minute is recorded
myokine assessment
irisin levels will be determined in the blood sample
posture
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
Thoracic kyphosis and lumbar lordosis angles will be evaluated in the sagittal plane with spinal mouse device.
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.
static balance
static balance will be evaluated functional reach test
dynamic balance
Balance will be evaluated using one-legged standing test
functional mobility
functional mobility will be evaluated time-up go test
Mcgill core endurance test
Endurance of trunk muscles will be evaluated trunk flexor, trunk extensor and side plank test
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.
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

Full Information

First Posted
October 31, 2021
Last Updated
November 24, 2021
Sponsor
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT05147285
Brief Title
The Effect of Telerehabilitation on Functional Capacity, Oxidative Stress and Respiratory Parameters in Cystic Fibrosis
Official Title
The Effect of Different Exercise Modalities Applied by Tele Rehabilitation on Functional Capacity, Oxidative Stress and Respiratory Parameters in Cystic Fibrosis Children
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
October 22, 2021 (Actual)
Primary Completion Date
May 2022 (Anticipated)
Study Completion Date
May 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis, Telerehabilitation
Keywords
exercise, oxidative stress, respiratory muscles

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
39 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stabilization group
Arm Type
Experimental
Arm Description
Only stabilization exercises in patients with cystic fibrosis
Arm Title
combined group
Arm Type
Experimental
Arm Description
stabilization exercise and aerobic exercise training in patients with cystic fibrosis
Arm Title
control group
Arm Type
Experimental
Arm Description
physical activity recommendations in patients with cystic fibrosis
Intervention Type
Other
Intervention Name(s)
stabilization exercises
Intervention Description
Patients will be applied only online supervised stabilization exercises three times a week for 8 weeks.
Intervention Type
Other
Intervention Name(s)
combined exercises
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Physical activity recommendations
Intervention Description
The importance of physical activity will be explained to the patients and appropriate physical activity recommendations will be made.
Primary Outcome Measure Information:
Title
six minute walk test distance
Description
Six-minute walk test distance is recorded
Time Frame
10 minutes
Title
shuttle walk test distance
Description
shuttle walk test distance is recorded
Time Frame
15 minutes
Secondary Outcome Measure Information:
Title
Respiratory muscle strength
Description
Respiratory muscle strength will be evaluated using mouth pressure device
Time Frame
10 minutes
Title
Respiratory muscle endurance
Description
Respiratory muscle endurance will be evaluated using constant load test
Time Frame
10 minutes
Title
Pulmonary functions
Description
Forced vital capacity (FVC) assessment via spirometry
Time Frame
15 minutes
Title
Pulmonary functions
Description
FEV 1(f Forced expiratory volume at one second (FEV1) assessment via spirometry
Time Frame
15 minutes
Title
Pulmonary functions
Description
Peak expiratory flow (PEF) assessment via spirometry
Time Frame
15 minutes
Title
Oxidative stress
Description
Malondialdehyde (MDA), will be determined in the blood samples.
Time Frame
through study completion, an average of 5 month
Title
Oxidative stress
Description
Carbonyl protein, will be determined in the blood samples.
Time Frame
through study completion, an average of 5 month
Title
Oxidative stress
Description
Superoxide dismutase (SOD) will be determined in the blood samples
Time Frame
through study completion, an average of 5 month
Title
Oxidative stress
Description
Catalase (CAT) will be determined in the blood samples
Time Frame
through study completion, an average of 5 month
Title
Oxidative stress
Description
Total oxidant status (TOS) will be determined in the blood samples
Time Frame
through study completion, an average of 5 month
Title
Oxidative stress
Description
Total antioxidant status (TAS) will be determined in the blood samples
Time Frame
through study completion, an average of 5 month
Title
Peripheral muscle strength
Description
Peripheral muscle strength will be evaluated using dynamometer
Time Frame
5 minutes
Title
crunch repetitions
Description
number of crunch completed is recorded
Time Frame
2 minutes
Title
squat repetitions
Description
number of squats completed is recorded
Time Frame
2 minutes
Title
push-up repetitions
Description
number of push-ups completed is recorded
Time Frame
2 minutes
Title
plank duration
Description
duration of keeping plank position is recorded
Time Frame
3 minutes
Title
1 minute sit to stand test (STS) repetitions
Description
number of sit to stand for one minute is recorded
Time Frame
2 minutes
Title
myokine assessment
Description
irisin levels will be determined in the blood sample
Time Frame
through study completion, an average of 5 month
Title
posture
Description
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
5 minutes
Title
posture
Description
Thoracic kyphosis and lumbar lordosis angles will be evaluated in the sagittal plane with spinal mouse device.
Time Frame
10 minutes
Title
balance
Description
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
15 minutes
Title
static balance
Description
static balance will be evaluated functional reach test
Time Frame
2 minutes
Title
dynamic balance
Description
Balance will be evaluated using one-legged standing test
Time Frame
2 minutes
Title
functional mobility
Description
functional mobility will be evaluated time-up go test
Time Frame
2 minutes
Title
Mcgill core endurance test
Description
Endurance of trunk muscles will be evaluated trunk flexor, trunk extensor and side plank test
Time Frame
10 minutes
Title
Quality of life assessment
Description
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
15 minutes
Title
Physical activity assessment
Description
Physical activity levels will be assessed by The Physical Activity Questionnaire. Score range is 1-5. Higher scores indicating higher physical activity
Time Frame
15 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kubra Kilic, PhD Student
Phone
+903123051576
Email
fztktas@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hacettepe University
Phone
+903123051576
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deniz Dogru-Ersoz, Professor
Organizational Affiliation
Hacettepe University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hacettepe University
City
Ankara
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kubra Kilic, MsC
Phone
+903123051576
Email
fztktas@gmail.com
First Name & Middle Initial & Last Name & Degree
Hacettepe University
Phone
+903123051576

12. IPD Sharing Statement

Learn more about this trial

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

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