The Effect of Telerehabilitation on Functional Capacity, Oxidative Stress and Respiratory Parameters in Cystic Fibrosis
The Effect of Different Exercise Modalities Applied by Tele Rehabilitation on Functional Capacity, Oxidative Stress and Respiratory Parameters in Cystic Fibrosis Children
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Kubra Kilic, PhD Student
- Phone Number: +903123051576
- Email: fztktas@gmail.com
Study Locations
-
-
-
Ankara, Turkey
- Hacettepe University
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Stabilization group
Only stabilization exercises in patients with cystic fibrosis
|
Patients will be applied only online supervised stabilization exercises three times a week for 8 weeks.
|
|
Experimental: combined group
stabilization exercise and aerobic exercise training in patients with cystic fibrosis
|
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.
|
|
Experimental: control group
physical activity recommendations in patients with cystic fibrosis
|
The importance of physical activity will be explained to the patients and appropriate physical activity recommendations will be made.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
six minute walk test distance
Time Frame: before the exercise training
|
Six-minute walk test distance is recorded
|
before the exercise training
|
|
six minute walk test distance
Time Frame: eight week
|
Six-minute walk test distance is recorded
|
eight week
|
|
shuttle walk test distance
Time Frame: before exercise training
|
shuttle walk test distance is recorded
|
before exercise training
|
|
shuttle walk test distance
Time Frame: eight week
|
shuttle walk test distance is recorded
|
eight week
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
1 minute sit to stand test (STS) repetitions
Time Frame: before exercise training
|
number of sit to stand for one minute is recorded
|
before exercise training
|
|
crunch repetitions
Time Frame: before exercise training
|
number of crunch completed is recorded
|
before exercise training
|
|
squat repetitions
Time Frame: before exercise training
|
number of squats completed is recorded
|
before exercise training
|
|
push-up repetitions
Time Frame: before exercise training
|
number of push-ups completed is recorded
|
before exercise training
|
|
plank duration
Time Frame: before exercise training
|
duration of keeping plank position is recorded
|
before exercise training
|
|
Respiratory muscle strength
Time Frame: before exercise training
|
Respiratory muscle strength will be evaluated using mouth pressure device
|
before exercise training
|
|
Respiratory muscle strength
Time Frame: eight week
|
Respiratory muscle strength will be evaluated using mouth pressure device
|
eight week
|
|
Respiratory muscle endurance
Time Frame: before exercise training
|
Respiratory muscle endurance will be evaluated using constant load test
|
before exercise training
|
|
Respiratory muscle endurance
Time Frame: eight week
|
Respiratory muscle endurance will be evaluated using constant load test
|
eight week
|
|
Pulmonary functions-FVC
Time Frame: before exercise training
|
Forced vital capacity (FVC)
|
before exercise training
|
|
Pulmonary functions-FVC
Time Frame: eight week
|
Forced vital capacity (FVC)
|
eight week
|
|
Pulmonary functions-FEV1
Time Frame: before exercise training
|
Forced expiratory volume in the first second (FEV1)
|
before exercise training
|
|
Pulmonary functions-FEV1
Time Frame: eight week
|
Forced expiratory volume in the first second (FEV1)
|
eight week
|
|
Pulmonary functions-FEV1/FVC
Time Frame: before exercise training
|
FEV1/ FVC
|
before exercise training
|
|
Pulmonary functions-FEV1/FVC
Time Frame: eight week
|
FEV1/ FVC
|
eight week
|
|
Pulmonary functions-PEF
Time Frame: before exercise training
|
Peak Expiratory Flow (PEF)
|
before exercise training
|
|
Pulmonary functions-PEF
Time Frame: eight week
|
Peak Expiratory Flow (PEF)
|
eight week
|
|
Pulmonary functions-FEF25-75
Time Frame: before exercise training
|
Forced mid-expiratory flow (FEF25-75)
|
before exercise training
|
|
Pulmonary functions-FEF25-75
Time Frame: eight week
|
Forced mid-expiratory flow (FEF25-75)
|
eight week
|
|
Oxidative stress-MDA
Time Frame: before exercise training
|
Malondialdehyde (MDA) will be determined in the blood samples.
|
before exercise training
|
|
Oxidative stress-MDA
Time Frame: eight week
|
Malondialdehyde (MDA) will be determined in the blood samples.
|
eight week
|
|
Oxidative stress-SOD
Time Frame: before exercise training
|
Superoxide dismutase (SOD) will be determined in the blood samples.
|
before exercise training
|
|
Oxidative stress-SOD
Time Frame: eight week
|
Superoxide dismutase (SOD) will be determined in the blood samples.
|
eight week
|
|
Oxidative stress-CAT
Time Frame: before exercise training
|
Catalase (CAT) will be determined in the blood samples.
|
before exercise training
|
|
Oxidative stress-CAT
Time Frame: eight week
|
Catalase (CAT) will be determined in the blood samples.
|
eight week
|
|
Oxidative stress-PC
Time Frame: before exercise training
|
Protein carbonyl (PC) will be determined in the blood samples.
|
before exercise training
|
|
Oxidative stress-PC
Time Frame: eight week
|
Protein carbonyl (PC) will be determined in the blood samples.
|
eight week
|
|
Oxidative stress-TOS
Time Frame: before exercise training
|
Total oxidant status (TOS) will be determined in the blood samples.
|
before exercise training
|
|
Oxidative stress-TOS
Time Frame: eight week
|
Total oxidant status (TOS) will be determined in the blood samples.
|
eight week
|
|
Oxidative stress-TAS
Time Frame: before exercise training
|
Total antioxidant status(TAS) will be determined in the blood samples.
|
before exercise training
|
|
Oxidative stress-TAS
Time Frame: eight week
|
Total antioxidant status (TAS) will be determined in the blood samples.
|
eight week
|
|
Oxidative stress-oxidative stress index
Time Frame: before exercise training
|
Oxidative stress index (TOS/TAS)
|
before exercise training
|
|
Oxidative stress-oxidative stress index
Time Frame: eight week
|
Oxidative stress index (TOS/TAS)
|
eight week
|
|
Peripheral muscle strength
Time Frame: before exercise training
|
Peripheral muscle strength will be evaluated using dynamometer
|
before exercise training
|
|
Peripheral muscle strength
Time Frame: eight week
|
Peripheral muscle strength will be evaluated using dynamometer
|
eight week
|
|
crunch repetitions
Time Frame: eight week
|
number of crunch completed is recorded
|
eight week
|
|
squat repetitions
Time Frame: eight week
|
number of squats completed is recorded
|
eight week
|
|
push-up repetitions
Time Frame: eight week
|
number of push-ups completed is recorded
|
eight week
|
|
plank duration
Time Frame: eight week
|
duration of keeping plank position is recorded
|
eight week
|
|
1 minute sit to stand test (STS) repetitions
Time Frame: eight week
|
number of sit to stand for one minute is recorded
|
eight week
|
|
myokine assessment
Time Frame: before exercise training
|
irisin levels will be determined in the blood sample
|
before exercise training
|
|
myokine assessment
Time Frame: eight week
|
irisin levels will be determined in the blood sample
|
eight week
|
|
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).
|
before exercise training
|
|
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).
|
eight week
|
|
posture
Time Frame: before exercise training
|
Thoracic kyphosis and lumbar lordosis angles will be evaluated in the sagittal plane with spinal mouse device.
|
before exercise training
|
|
posture
Time Frame: eight week
|
Thoracic kyphosis and lumbar lordosis angles will be evaluated in the sagittal plane with spinal mouse device.
|
eight week
|
|
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.
|
before exercise training
|
|
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.
|
eight week
|
|
static balance
Time Frame: before exercise training
|
static balance will be evaluated functional reach test
|
before exercise training
|
|
static balance
Time Frame: eight week
|
static balance will be evaluated functional reach test
|
eight week
|
|
dynamic balance
Time Frame: before exercise training
|
Balance will be evaluated using one-legged standing test
|
before exercise training
|
|
dynamic balance
Time Frame: eight week
|
Balance will be evaluated using one-legged standing test
|
eight week
|
|
functional mobility
Time Frame: before exercise training
|
functional mobility will be evaluated time-up go test
|
before exercise training
|
|
functional mobility
Time Frame: eight week
|
functional mobility will be evaluated time-up go test
|
eight week
|
|
Mcgill core endurance test
Time Frame: before exercise training
|
Endurance of trunk muscles will be evaluated trunk flexor, trunk extensor and side plank test
|
before exercise training
|
|
Mcgill core endurance test
Time Frame: eight week
|
Endurance of trunk muscles will be evaluated trunk flexor, trunk extensor and side plank test
|
eight week
|
|
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.
|
before exercise training
|
|
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.
|
eight week
|
|
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
|
before exercise training
|
|
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
|
eight week
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Deniz Dogru-Ersoz, Professor, Hacettepe University
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- KA-20069
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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