Respiratory Muscle Strength, Exercise Capacity and Physical Activity Levels in Children Primary Ciliary Dyskinesia

NCT ID: NCT03370029

Last Updated: 2019-02-15

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

26 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-31

Study Completion Date

2018-06-30

Brief Summary

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Primary ciliary dyskinesia is an autosomal recessive disorder characterized by abnormal ciliary movement and disrupted mucociliary clearance. In uncleaned airways, microorganisms and respiratory irritants cause inflammation and infection. Permanent rhinitis and chronic sputum cough are typical features in primary ciliary dyskinesia patients. Primary ciliary dyskinesia is a disease that threatens lung function from pre-school age. One of the main causes of respiratory muscle weakness in chronic lung diseases diseases is worsening of lung function. Such a weakness causes alveolar hypoventilation, microatelectasis, reduction of the cough strength .The cough strength is important for airway cleaning.

Exercise capacity is affected in chronic lung diseases. Assessment of exercise capacity in chronic lung diseases is prognostically important. Reduced exercise capacity and pulmonary function in PCD cause decrease in physical activity level. PCD patients have low quality of life and early recognition has been found to affect the quality of life positively. Children with chronic illness have higher level of depression than healthy children.

In literature, no study investigated respiratory muscle strength, exercise capacity and physical activity PCD patients. Therefore, the investigators aimed to compare aforementioned outcomes in PCD patients and healthy controls.

Detailed Description

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According to sample size calculation 26 diagnosed primary ciliary dyskinesia patients and 26 healthy individuals will be included. Respiratory muscle strength, anaerobic and aerobic exercise capacity, physical activity, pulmonary functions, peripheral muscle strength, cough strength, respiratory muscle endurance, activity dyspnea perception, quality of life and depression will be evaluated. Primary outcome measurements are respiratory muscle strength, exercise capacity, physical activity; secondary outcomes are pulmonary functions, peripheral muscle strength, cough strength, respiratory muscle endurance, activity dyspnea perception, quality of life and depression.

Conditions

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Primary Ciliary Dyskinesia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Primary ciliary dyskinesia patients

Primary ciliary dyskinesia patients will be included in study. Inclusion and exclusion criteria were considered.

No interventions assigned to this group

Healthy individuals

Those without diagnosed chronic disease will be included in study. Inclusion and exclusion criteria were considered.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Diagnosed primary ciliary dyskinesia patients,
* 6-18 years of age,
* under standard medications,
* stable patients without exacerbation or infection

Exclusion Criteria

* having cognitive disorder,
* orthopedic or neurological disease with a potential to affect functional capacity,
* acute infections or pneumonia,
* problems which may prevent evaluating such as visual problems
Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Gazi University

OTHER

Sponsor Role lead

Responsible Party

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Meral Boşnak Güçlü

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Merve Fırat, Pt

Role: STUDY_CHAIR

Research assistant

Meral Boşnak Güçlü, Pt,Phd

Role: STUDY_DIRECTOR

Associate professor

Tuğba Şişmanlar Eyüboğlu, MD

Role: PRINCIPAL_INVESTIGATOR

Medical doctor

Ayşe Tana Aslan, MD,Phd

Role: PRINCIPAL_INVESTIGATOR

Professor

Locations

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Gazi University Faculty of Health Sciences Department of Physical Therapy and Rehabilitation

Yenimahalle, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Firat M, Bosnak-Guclu M, Sismanlar-Eyuboglu T, Aslan AT. Aerobic exercise capacity, cough strength, posture, and depression in primary ciliary dyskinesia. Pediatr Pulmonol. 2023 Jan;58(1):73-80. doi: 10.1002/ppul.26158. Epub 2022 Sep 28.

Reference Type DERIVED
PMID: 36114723 (View on PubMed)

Firat M, Bosnak-Guclu M, Sismanlar-Eyuboglu T, Tana-Aslan A. Respiratory muscle strength, exercise capacity and physical activity in patients with primary ciliary dyskinesia: A cross-sectional study. Respir Med. 2022 Jan;191:106719. doi: 10.1016/j.rmed.2021.106719. Epub 2021 Dec 17.

Reference Type DERIVED
PMID: 34952415 (View on PubMed)

Related Links

Other Identifiers

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Gazi University5

Identifier Type: -

Identifier Source: org_study_id

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