Clinical trial NCT05712798: Physiological Responses to Exercise Tests in Primary Ciliary Dyskinesia Compared With Healthy Individuals
Official title: Physiological Responses to Exercise Tests in Primary Ciliary Dyskinesia Compared With Healthy Children and Investigation of the Relationship Between Exercise Capacity and Quality of Life in Primary Ciliary Dyskinesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Ciliary Dyskinesia
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2023-02-03
Enrollment: 46
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The children with primary ciliary dyskinesia and healthy children

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Shuttle walk test distance
timeFrame: up to 3 weeks
measure: Quality of life score
timeFrame: 1st day
measure: Maximal oxygen uptake
timeFrame: up to 3 weeks
measure: 6 minute walk test distance
timeFrame: up to 3 weeks
Secondary outcomes:
measure: Pulmonary function test - forced vital capacity
timeFrame: 1st day
measure: Pulmonary function test - Forced expiratory volume in one second
timeFrame: 1st day
measure: Maximal inspiratory pressure
timeFrame: 1st day
measure: Maximal expiratory pressure
timeFrame: 1st day
measure: Pulmonary function test - Peak expiratory flow
timeFrame: 1st day
measure: Pulmonary function test - Forced mid-expiratory flow (FEF25-75)
timeFrame: 1stday
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University Faculty of Physical Therapy and Rehabilitation
Study officials:
affiliation: Hacettepe University
name: Deniz Inal-Ince
role: STUDY_CHAIR
affiliation: Hacettepe University
name: Ugur Ozcelik
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University
name: Nagehan Emiralioglu
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University
name: Melda Saglam
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University
name: Naciye Vardar-Yagli
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University
name: Ebru Calik-Kutukcu
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University
name: Birce Sunman
role: PRINCIPAL_INVESTIGATOR
affiliation: Akdeniz University
name: Hazal Sonbahar-Ulu
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University
name: Aslihan Cakmak
role: PRINCIPAL_INVESTIGATOR
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