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

NCT05712798 | Completed

• 1 other identifier: GO 20/647
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Ciliary Dyskinesia

Outcome Measures

Primary Outcomes (4)

• Shuttle walk test distance

  Shuttle walk test distance will be determined using shuttle walk test

  up to 3 weeks

• 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

• Maximal oxygen uptake

  Maximal oxygen uptake will be determined using cardiopulmonary exercise test.

  up to 3 weeks

• 6 minute walk test distance

  6 minute walk test distance will be determined using 6 minute walk test

  up to 3 weeks

Secondary Outcomes (6)

• Pulmonary function test - forced vital capacity

  1st day

• Pulmonary function test - Forced expiratory volume in one second

  1st day

• Maximal inspiratory pressure

  1st day

• Maximal expiratory pressure

  1st day

• Pulmonary function test - Peak expiratory flow

  1st day

Study Arms (2)

The children with primary ciliary dyskinesia

The children with primary ciliary dyskinesia

Other: No intervention

Healthy controls

Healthy children

Other: No intervention

Interventions

No intervention OTHER

No intervention

Healthy controls; The children with primary ciliary dyskinesia

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The children with primary ciliary dyskinesia and healthy children

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University Faculty of Physical Therapy and Rehabilitation

Ankara, 06100, Turkey (Türkiye)

Location

Related Publications (1)

• Cakmak-Onal A, Kocaaga E, Sonbahar-Ulu H, Calik E, Vardar-Yagli N, Saglam M, Sunman B, Emiralioglu N, Ozcelik U, Inal-Ince D. Physiological responses to cardiopulmonary and field exercise tests in primary ciliary dyskinesia compared with healthy peers. Eur J Appl Physiol. 2025 Nov 4. doi: 10.1007/s00421-025-06019-2. Online ahead of print.

  PMID: 41186743 DERIVED

MeSH Terms

Conditions

Ciliary Motility Disorders

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Ciliopathies; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn

Study Officials

• Deniz Inal-Ince

  Hacettepe University

  STUDY CHAIR

• Ugur Ozcelik

  Hacettepe University

  PRINCIPAL INVESTIGATOR

• Nagehan Emiralioglu

  Hacettepe University

  PRINCIPAL INVESTIGATOR

• Melda Saglam

  Hacettepe University

  PRINCIPAL INVESTIGATOR

• Naciye Vardar-Yagli

  Hacettepe University

  PRINCIPAL INVESTIGATOR

• Ebru Calik-Kutukcu

  Hacettepe University

  PRINCIPAL INVESTIGATOR

• Birce Sunman

  Hacettepe University

  PRINCIPAL INVESTIGATOR

• Hazal Sonbahar-Ulu

  Akdeniz University

  PRINCIPAL INVESTIGATOR

• Aslihan Cakmak

  Hacettepe University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 26, 2023
• First Posted: February 3, 2023
• Study Start: October 7, 2020
• Primary Completion: October 7, 2023
• Study Completion: October 7, 2023
• Last Updated: July 1, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)