Physical Impairments in Children With Cystic Fibrosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-18
SponsorIzmir Democracy University
About this trial
It is aimed to reveal impairments regarding urinary incontinence, dyspnea, muscle strength, functional capacity or quality of life in children and adolescents with cystic fibrosis compared to healthy children and adolescents.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
To be between the ages of 6-18
To have been diagnosed with cystic fibrosis
To be clinically stable for at least 3 weeks
To have the necessary cooperation for the measurements
Disqualifiers
Having any orthopedic, neurological, psychological or cardiovascular problem that may prevent the measurements from being performed in the last 6 months
Smoking or quitting smoking
Having any orthopedic, neurological, psychological or cardiovascular problem that may prevent the measurements from being performed in the last 6 months
Having any chronic disease
Trial population
At least 25 patients with cystic fibrosis will be included in the main group and at least 25 healthy individuals will be included in the control group.
Trial design
Design model
Case-control
Time perspective
Cross-sectional
Treatments tested in this trial
Physical Evaluations in Children with Cystic Fibrosis
Other interventionIn this study, dyspnea, functional capacity, muscle strength, urinary incontinence and quality of life will be evaluated in children and adolescents with cystic fibrosis. The data to be obtained through all these evaluations will be done face to face within 45-60 minutes.
Physical Evaluations in Healthy Children
Other interventionIn this study, dyspnea, functional capacity, muscle strength, urinary incontinence and quality of life will be evaluated in healthy children and adolescents. The data to be obtained from all these assessments will be made face to face within 45-60 minutes.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Cystic Fibrosis Group1 intervention
Group B: Control Group1 intervention
Trial outcomes
Primary outcomes
1
Hand Grip Strength
Grip strength will be measured using a dynamometer. Each hand will be tested three times, and the highest value will be recorded for both sides.
Time frame
through study completion, an average of 1 yearSecondary outcomes
1
Dyspnea score
Dyspnea will be assessed with the Modified Medical Research Council (MMRC) Dyspnea Scale, scored from 0 (no dyspnea) to 4 (maximum severity).
Time frame
through study completion, an average of 1 year2
Pulmonary Function Test Evaluation
Lung function will be assessed with a spirometer. The highest value of the three measurements will be used and interpreted according to gender, age, weight and height. A value below 80% of the expected value will be interpreted as abnormal.
Time frame
through study completion, an average of 1 year3
Respiratory Muscle Strength Evaluation
Respiratory muscle strength will be assessed with a spirometer. The test will be conducted with the participant seated, using a mouthpiece and a nose clip. The highest value for inspiratory and expiratory pressure will be recorded. A value below 80% of the expected value will be interpreted as abnormal.
Time frame
through study completion, an average of 1 year4
Cough Strength Evaluation
The peak cough expiratory flow of the individual will be assessed using a peak flow meter. The best of at least three repetitions is recorded.A value above 450 indicates effective cough.
Time frame
through study completion, an average of 1 yearSponsors and contacts
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Source ClinicalTrials.gov