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

NCT ID: NCT04161313

Last Updated: 2020-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

76 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-12-20

Study Completion Date

2020-03-12

Brief Summary

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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

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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.

Conditions

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Primary Ciliary Dyskinesia Cystic Fibrosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Cystic fibrosis

children with cystic fibrosis

Measurement of functional capacity

Intervention Type OTHER

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

pulmonary function test

Intervention Type OTHER

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

Functional capacity

Intervention Type OTHER

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

Peripheral muscle strength

Intervention Type OTHER

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

Respiratory muscle strength

Intervention Type OTHER

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

primary ciliary dyskinesia

children with primary ciliary dyskinesia

Measurement of functional capacity

Intervention Type OTHER

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

pulmonary function test

Intervention Type OTHER

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

Functional capacity

Intervention Type OTHER

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

Peripheral muscle strength

Intervention Type OTHER

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

Respiratory muscle strength

Intervention Type OTHER

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

healthy controls

Age-matched healthy volunteers

Measurement of functional capacity

Intervention Type OTHER

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

pulmonary function test

Intervention Type OTHER

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

Functional capacity

Intervention Type OTHER

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

Peripheral muscle strength

Intervention Type OTHER

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

Respiratory muscle strength

Intervention Type OTHER

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

Interventions

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Measurement of functional capacity

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

Intervention Type OTHER

pulmonary function test

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

Intervention Type OTHER

Functional capacity

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

Intervention Type OTHER

Peripheral muscle strength

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

Intervention Type OTHER

Respiratory muscle strength

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bezmialem Vakif University

OTHER

Sponsor Role lead

Responsible Party

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Hilal Denizoğlu Külli

Lecturer in Department of Physiotheray and Rehabilitation

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hilal Denizoglu Kulli, PhD

Role: STUDY_DIRECTOR

Bezmialem Vakif University

Locations

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Bezmialem Vakıf University

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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hdenizkulli2

Identifier Type: -

Identifier Source: org_study_id

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