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OpenTrials
Completed

NCT Number: NCT05712798

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

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.

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Key information

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hacettepe University Faculty of Physical Therapy and Rehabilitation

Ankara, 06100, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. Shuttle walk test distance

    Time frame: up to 3 weeks

    Shuttle walk test distance will be determined using shuttle walk test

  2. Quality of life score

    Time frame: 1st day

    Quality of life score will be determined using multidimensional measure to assess health-related quality of life in primary ciliary dyskinesia (QoL-PCD).

  3. Maximal oxygen uptake

    Time frame: up to 3 weeks

    Maximal oxygen uptake will be determined using cardiopulmonary exercise test.

  4. 6 minute walk test distance

    Time frame: up to 3 weeks

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

Secondary outcomes

  1. Pulmonary function test - forced vital capacity

    Time frame: 1st day

    Pulmonary function test using a spirometer will be performed. Forced vital capacity will be recorded.

  2. Pulmonary function test - Forced expiratory volume in one second

    Time frame: 1st day

    Pulmonary function test using a spirometer will be performed. Forced expiratory volume in one second will be recorded.

  3. Maximal inspiratory pressure

    Time frame: 1st day

    Maximal inspiratory pressure will be measured using a mouthpiece device.

  4. Maximal expiratory pressure

    Time frame: 1st day

    Maximal expiratory pressure will be measured using a mouthpiece device.

  5. Pulmonary function test - Peak expiratory flow

    Time frame: 1st day

    Pulmonary function test using a spirometer will be performed. Peak expiratory flow will be recorded.

  6. Pulmonary function test - Forced mid-expiratory flow (FEF25-75)

    Time frame: 1stday

    Pulmonary function test using a spirometer will be performed. Peak expiratory flow will be recorded.

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Feb 3, 2023
Registry last updated
Jul 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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