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

Cystic Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04161313
• Other study ID #: hdenizkulli2
• Status: Completed
• Start date: December 20, 2019
• Est. completion date: March 12, 2020

Study information

• Verified date: March 2020
• Source: Bezmialem Vakif University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: March 12, 2020
• Est. primary completion date: February 24, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Ciliary Motility Disorders
• Cystic Fibrosis
• Dyskinesias
• Fibrosis
• Kartagener Syndrome
• Primary Ciliary Dyskinesia

Intervention

Other:
• Measurement of functional capacity
Functional capacity of participants will be measured with six-minute walk test.
• pulmonary function test
It will be measured using basic spirometry and presented lung volume parameters such as FEV1,FVC,FEV1/FVC,PEF, FEF25-75
• Functional capacity
Functional capacity of participants will be measured with six-minute walk test and sit-to-stand test
• Peripheral muscle strength
Isometric M. Quadriceps strength will be measured using electronic hand held dynamometer in sitting position.
• Respiratory muscle strength
Inspiratory and expiratory muscle strength has been assessed by maximal inspiratory and expiratory mouth pressures.

Locations

Country	Name	City	State
Turkey	Bezmialem Vakif University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Forced Vital Capacity (FVC)	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)	5 minutes
Secondary	Forced Expiratory Volume in 1 second (FEV1)	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)	5 minutes
Secondary	Peak Expiratory Flow (PEF)	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)	5 minutes
Secondary	M. Quadriceps strength	Isometric M. Quadriceps strength (kg) will be measured using electronic hand held dynamometer in sitting position.	5 minutes