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Completed

NCT Number: NCT04161313

Respiratory Function, Exercise Capacity and Peripheral Muscle Strength Among Patients With CF, PCD and Healthy Children

The aim of this study is to compare pulmonary function, respiratory muscle strength, exercise capacity and peripheral muscle strength of patients with CF, PCD and healthy childrens.

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Key information

Conditions

Primary Ciliary Dyskinesia Abnormalities, Multiple Ciliary Motility Disorders Ciliopathies Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cystic Fibrosis Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Otorhinolaryngologic Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Bezmialem Vakıf University

Istanbul, Turkey (Türkiye)

About this study

The impaired airway clearence and pulmonary functions, exercise intolerance, low physical activity level and decreased peripheral muscle strength make physiotherapy approaches important in the management of CF and PCD.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Diagnosis of cystic fibrosis or primary ciliary dyskinesia

Exclusion criteria

  • Hospitalization history in past month
  • Diagnosis of other chronic pediatric diseases which may impair exercise tolerance such as cerebral palsy or neuromuscular disease
  • Candidates for lung transplantation or history of lung transplantation

Treatment and study plan

Measurement of functional capacity

Other

Functional capacity of participants will be measured with six-minute walk test.

pulmonary function test

Other

It will be measured using basic spirometry and presented lung volume parameters such as FEV1,FVC,FEV1/FVC,PEF, FEF25-75

Functional capacity

Other

Functional capacity of participants will be measured with six-minute walk test and sit-to-stand test

Peripheral muscle strength

Other

Isometric M. Quadriceps strength will be measured using electronic hand held dynamometer in sitting position.

Respiratory muscle strength

Other

Inspiratory and expiratory muscle strength has been assessed by maximal inspiratory and expiratory mouth pressures.

Primary outcomes

  1. Six-minute walk test distance

    Time frame: 15 minutes

    Distance walked in six minutes will be recorded in meters. Test will be conducted according to the guideline of American Thoracic Society (ATS).

Secondary outcomes

  1. Forced Vital Capacity (FVC)

    Time frame: 5 minutes

    FVC will be measured using basic spirometry and expressed as the percentage of the predicted value according to the guideline of European Respiratory Society (ERS)

  2. Forced Expiratory Volume in 1 second (FEV1)

    Time frame: 5 minutes

    FEV1 will be measured using basic spirometry and expressed as the percentage of the predicted value according to the guideline of European Respiratory Society (ERS)

  3. Peak Expiratory Flow (PEF)

    Time frame: 5 minutes

    PEF will be measured using basic spirometry and expressed as the percentage of the predicted value according to the guideline of European Respiratory Society (ERS)

  4. M. Quadriceps strength

    Time frame: 5 minutes

    Isometric M. Quadriceps strength (kg) will be measured using electronic hand held dynamometer in sitting position.

Sponsors and collaborators

Lead sponsor

Bezmialem Vakif University

Other

Registry information

Official study title

Comparison of Respiratory Function, Exercise Capacity and Peripheral Muscle Strength Among Patients With Cystic Fibrosis, Primary Ciliary Dyskinesia and Healthy Children

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 13, 2019
Registry last updated
Mar 18, 2020

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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