Physiological Responses to Exercise Tests in Primary Ciliary Dyskinesia Compared With Healthy Individuals

NCT ID: NCT05712798

Last Updated: 2024-07-01

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

46 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-07

Study Completion Date

2023-10-07

Brief Summary

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The individuals with primary ciliary dyskinesia (PCD) have lower aerobic fitness and anaerobic performance than healthy individuals. Cardiopulmonary exercise test (CPET) provides an integrated assessment of integrative exercise responses involving the pulmonary, cardiovascular, hematopoietic, neuropsychological, and skeletal muscle systems that are not adequately reflected by measurement of the function of organ systems. Maximum oxygen consumption is measured by performing gas exchange analysis with CPET, offering an objective measure of cardiorespiratory fitness. The six-minute walk test (6MWT) and the shuttle walk test (SWT) are field tests that produce oxygen consumption results similar to those during CPET. There is a need to determine the physiological responses to CPET, SWT and 6MWT in individuals with PCD. Additionally, the physiological responses of individuals with PCD to different exercise tests will be compared with the responses of healthy individuals. Low aerobic capacity in individuals with PCD may affect the physical, emotional, and social lives of individuals. This influence may cause a decrease in the quality of life of individuals with PCD. The relationship between exercise capacity and quality of life in individuals with PSD will be investigated with this study.

Detailed Description

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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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The children with primary ciliary dyskinesia

The children with primary ciliary dyskinesia

No intervention

Intervention Type OTHER

No intervention

Healthy controls

Healthy children

No intervention

Intervention Type OTHER

No intervention

Interventions

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No intervention

No intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Having been diagnosed with PCD in the Pediatrics Department, Pediatric Chest Diseases Unit of Hacettepe University Faculty of Medicine and being routinely referred to Hacettepe University, Faculty of Physical Therapy and Rehabilitation, Cardiopulmonary Rehabilitation Unit for physiotherapy applications and pulmonary rehabilitation program,
* Being clinically stable,
* Being between 8-18 years old,
* Having a forced expiratory volume in the first second (FEV1) ≥ 40%,

The healthy group will be composed of individuals who do not have any known disease and volunteer to participate in the study. For healthy individuals, volunteers from acquaintances and/or relatives of the researchers will be included in the study.

Exclusion Criteria

* Having unstable clinical condition
* Having severe neuromuscular and musculoskeletal problems,
* Having any congenital heart diseases other than situs inversus,
* Unable to cooperate
Minimum Eligible Age

8 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hacettepe University

OTHER

Sponsor Role lead

Responsible Party

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Aslihan Cakmak

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Deniz Inal-Ince

Role: STUDY_CHAIR

Hacettepe University

Ugur Ozcelik

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University

Nagehan Emiralioglu

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University

Melda Saglam

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University

Naciye Vardar-Yagli

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University

Ebru Calik-Kutukcu

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University

Birce Sunman

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University

Hazal Sonbahar-Ulu

Role: PRINCIPAL_INVESTIGATOR

Akdeniz University

Aslihan Cakmak

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University

Locations

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Hacettepe University Faculty of Physical Therapy and Rehabilitation

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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GO 20/647

Identifier Type: -

Identifier Source: org_study_id

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