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NCT Number: NCT06984679

Physical Impairments in Children With Cystic Fibrosis

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.

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Key information

Conditions

Cystic Fibrosis (CF) Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cystic Fibrosis Cystic Fibrosis in Children Digestive System Diseases Dyspnea Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Infant, Newborn, Diseases Lower Urinary Tract Symptoms Lung Diseases Male Urogenital Diseases Pancreatic Diseases Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Urinary Incontinence Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Izmir Democracy University

Izmir, 35140, Turkey (Türkiye)

Location status: Recruiting

Location contact

Gülşah Barğı, Assoc Prof

CONTACT

[email protected]

+905317938766

About this study

This study aims to compare dyspnea, functional capacity, muscle strength, urinary incontinence and quality of life between children and adolescents with cystic fibrosis and healthy children and adolescents. Participants will be assessed for these parameters through clinical evaluations, exercise tests, questionnaires and measurements. The study aims to understand the health implications of cystic fibrosis and provide the basis for improvements in the health management of these individuals.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for Children and Adolescents with Cystic Fibrosis:

  • 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
  • To volunteer to participate in the study

Inclusion criteria

for Healthy Children and Adolescents:

  • To be between the ages of 6-18
  • To be in a similar average and ratio with the group of children and adolescents with cystic fibrosis in terms of age and gender
  • To have the necessary cooperation for the measurements
  • To volunteer to participate in the study

Exclusion criteria

for Children and Adolescents with Cystic Fibrosis:

  • 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

Exclusion criteria

for Healthy Children and Adolescents:

  • 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
  • Smoking or quitting smoking

Treatment and study plan

Physical Evaluations in Children with Cystic Fibrosis

Other

In 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

In 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.

Primary outcomes

  1. Hand Grip Strength

    Time frame: through study completion, an average of 1 year

    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.

Secondary outcomes

  1. Dyspnea score

    Time frame: through study completion, an average of 1 year

    Dyspnea will be assessed with the Modified Medical Research Council (MMRC) Dyspnea Scale, scored from 0 (no dyspnea) to 4 (maximum severity).

  2. Pulmonary Function Test Evaluation

    Time frame: through study completion, an average of 1 year

    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.

  3. Respiratory Muscle Strength Evaluation

    Time frame: through study completion, an average of 1 year

    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.

  4. Cough Strength Evaluation

    Time frame: through study completion, an average of 1 year

    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.

  5. Aerobic Exercise Capacity Evaluation

    Time frame: through study completion, an average of 1 year

    Aerobic capacity will be assessed twice via 6-minute walk test. The longest distance will be used for analysis. A value below 80% of the expected value will be interpreted as abnormal.

  6. Anaerobic Exercise Capacity Evaluation

    Time frame: through study completion, an average of 1 year

    Anaerobic capacity will be assessed via the 3-minute step test (3-STT). For the 3-STT, participants will rest for 10 minutes before performing the test with a 15 cm step at a rate of 30 steps per minute, controlled by a metronome. The total number of steps will be recorded.A high number of steps indicates good capacity.

  7. Quality of Life Score

    Time frame: through study completion, an average of 1 year

    The scale we will use to assess health-related quality of life, the Pediatric Quality of Life Inventory (PedsQL 4.0). The scale was developed to assess the health-related quality of life of children and adolescents between the ages of 2 and 18 and consists of physical, emotional, social and school functioning items, totaling 23 items.Scores from this questionnaire are converted to a scale of 0 to 100. Higher scores indicate better health-related quality of life.

  8. Urinary incontinence score

    Time frame: through study completion, an average of 1 year

    Urinary incontinence will be assessed using the Voiding Dysfunction Symptom Score, a 15-item questionnaire. A score above 8.5 indicates the presence of lower urinary tract symptoms.

Study contacts

Contact information is provided by the study sponsor or research team.

Gülşah Barğı, Assoc Prof

CONTACT

[email protected]

+90 232 299 0739

Yağmur Külekçi, PT

CONTACT

[email protected]

+90 533 661 4001

Sponsors and collaborators

Lead sponsor

Izmir Democracy University

Other

Registry information

Official study title

Comparison of Dyspnea, Functional Capacity, Muscle Strength, Urinary Incontinence and Quality of Life Between Children and Adolescents With Cystic Fibrosis and Healthy Children

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 22, 2025
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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