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

Primary Ciliary Dyskinesia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05712798
• Other study ID #: GO 20/647
• Status: Completed
• Start date: October 7, 2020
• Est. completion date: October 7, 2023

Study information

• Verified date: January 2024
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: October 7, 2023
• Est. primary completion date: October 7, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Ciliary Motility Disorders
• Dyskinesias
• Primary Ciliary Dyskinesia

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
Turkey	Hacettepe University	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Shuttle walk test distance	Shuttle walk test distance will be determined using shuttle walk test	up to 3 weeks
Primary	Quality of life score	Quality of life score will be determined using multidimensional measure to assess health-related quality of life in primary ciliary dyskinesia (QoL-PCD).	1st day
Primary	Maximal oxygen uptake	Maximal oxygen uptake will be determined using cardiopulmonary exercise test.	up to 3 weeks
Primary	6 minute walk test distance	6 minute walk test distance will be determined using 6 minute walk test	up to 3 weeks
Secondary	Pulmonary function test - forced vital capacity	Pulmonary function test using a spirometer will be performed. Forced vital capacity will be recorded.	1st day
Secondary	Pulmonary function test - Forced expiratory volume in one second	Pulmonary function test using a spirometer will be performed. Forced expiratory volume in one second will be recorded.	1st day
Secondary	Maximal inspiratory pressure	Maximal inspiratory pressure will be measured using a mouthpiece device.	1st day
Secondary	Maximal expiratory pressure	Maximal expiratory pressure will be measured using a mouthpiece device.	1st day
Secondary	Pulmonary function test - Peak expiratory flow	Pulmonary function test using a spirometer will be performed. Peak expiratory flow will be recorded.	1st day
Secondary	Pulmonary function test - Forced mid-expiratory flow (FEF25-75)	Pulmonary function test using a spirometer will be performed. Peak expiratory flow will be recorded.	1stday