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

NCT04161313 | Completed

• 1 other identifier: hdenizkulli2
• Study Type: observational
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Primary Ciliary Dyskinesia; Cystic Fibrosis

Keywords

respiratory functions; exercise capacity; muscle strength

Outcome Measures

Primary Outcomes (1)

• Six-minute walk test distance

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

  15 minutes

Secondary Outcomes (4)

• Forced Vital Capacity (FVC)

  5 minutes

• Forced Expiratory Volume in 1 second (FEV1)

  5 minutes

• Peak Expiratory Flow (PEF)

  5 minutes

• M. Quadriceps strength

  5 minutes

Study Arms (3)

Cystic fibrosis

children with cystic fibrosis

Other: Measurement of functional capacity; Other: pulmonary function test; Other: Functional capacity; Other: Peripheral muscle strength; Other: Respiratory muscle strength

primary ciliary dyskinesia

children with primary ciliary dyskinesia

Other: Measurement of functional capacity; Other: pulmonary function test; Other: Functional capacity; Other: Peripheral muscle strength; Other: Respiratory muscle strength

healthy controls

Age-matched healthy volunteers

Other: Measurement of functional capacity; Other: pulmonary function test; Other: Functional capacity; Other: Peripheral muscle strength; Other: Respiratory muscle strength

Interventions

Measurement of functional capacity OTHER

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

Cystic fibrosis; healthy controls; primary ciliary dyskinesia

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

Cystic fibrosis; healthy controls; primary ciliary dyskinesia

Functional capacity OTHER

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

Cystic fibrosis; healthy controls; primary ciliary dyskinesia

Peripheral muscle strength OTHER

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

Cystic fibrosis; healthy controls; primary ciliary dyskinesia

Respiratory muscle strength OTHER

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

Cystic fibrosis; healthy controls; primary ciliary dyskinesia

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Children diagnosed with cystic fibrosis and primary ciliary dyskinesia and age matched healthy volunteers who do not have any diagnosed chronic diseases

You may qualify if:

• Diagnosis of cystic fibrosis or primary ciliary dyskinesia

You may not qualify if:

• 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

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Bezmialem Vakıf University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Ciliary Motility Disorders; Cystic Fibrosis

Interventions

Respiratory Physiological Phenomena; Functional Residual Capacity

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Ciliopathies; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn; Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Infant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Circulatory and Respiratory Physiological Phenomena; Total Lung Capacity; Lung Volume Measurements; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Hilal Denizoglu Kulli, PhD

  Bezmialem Vakif University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer in Department of Physiotheray and Rehabilitation

Study Record Dates

• First Submitted: November 8, 2019
• First Posted: November 13, 2019
• Study Start: December 20, 2019
• Primary Completion: February 24, 2020
• Study Completion: March 12, 2020
• Last Updated: March 18, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)