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

Completed

• Conditions: Primary Ciliary Dyskinesia; Cystic Fibrosis
• Interventions: Other: Measurement of functional capacity; Other: pulmonary function test; Other: Functional capacity; Other: Peripheral muscle strength; Other: Respiratory muscle strength

• Registration Number: NCT04161313
• Lead Sponsor: Bezmialem Vakif University

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2019-11-08
• Study First Submitted QC: 2019-11-11
• Study First Posted: 2019-11-13
• Study Start: 2019-12-20
• Primary Completion: 2020-02-24
• Status Verified: 2020-03
• Study Completion: 2020-03-12
• Last Update Submitted: 2020-03-17
• Last Update Posted: 2020-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cystic fibrosis	Peripheral muscle strength	children with cystic fibrosis
Cystic fibrosis	pulmonary function test	children with cystic fibrosis
Cystic fibrosis	Functional capacity	children with cystic fibrosis
healthy controls	Respiratory muscle strength	Age-matched healthy volunteers
primary ciliary dyskinesia	pulmonary function test	children with primary ciliary dyskinesia
Cystic fibrosis	Measurement of functional capacity	children with cystic fibrosis
primary ciliary dyskinesia	Measurement of functional capacity	children with primary ciliary dyskinesia
healthy controls	Measurement of functional capacity	Age-matched healthy volunteers
healthy controls	Functional capacity	Age-matched healthy volunteers
primary ciliary dyskinesia	Peripheral muscle strength	children with primary ciliary dyskinesia
healthy controls	pulmonary function test	Age-matched healthy volunteers
healthy controls	Peripheral muscle strength	Age-matched healthy volunteers
Cystic fibrosis	Respiratory muscle strength	children with cystic fibrosis
primary ciliary dyskinesia	Functional capacity	children with primary ciliary dyskinesia
primary ciliary dyskinesia	Respiratory muscle strength	children with primary ciliary dyskinesia

Primary Outcome Measures

Name	Time	Method
Six-minute walk test distance	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 Outcome Measures

Name	Time	Method
Forced Vital Capacity (FVC)	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)
Forced Expiratory Volume in 1 second (FEV1)	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)
Peak Expiratory Flow (PEF)	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)
M. Quadriceps strength	5 minutes	Isometric M. Quadriceps strength (kg) will be measured using electronic hand held dynamometer in sitting position.

Trial Locations

Locations (1)

Bezmialem Vakıf University; 🇹🇷 Istanbul, Turkey