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NCT Number: NCT05040607

Physical Fitness, Exercise Capacity and Activities of Daily Living in Primary Ciliary Dyskinesia: a Retrospective Study

Decreased pulmonary function, peripheral muscle strength, and exercise capacity were reported in primary ciliary dyskinesia (PCD) in recent studies. We aimed to investigate the data conducted between 10 July 2015 and 10 January 2015 of pulmonary function, respiratory muscle strength, exercise capacity, physical fitness, and activities of daily living (ADL) in PCD and healthy counterparts retrospectively at the first stage of the study and the effects of inspiratory muscle training on pulmonary function, respiratory muscle strength, and exercise capacity in PCD patients with decreased inspiratory muscle strength from the database recorded between 10 July 2015 and 10 January 2015 retrospectively at the second stage of the study.

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Key information

Conditions

Primary Ciliary Dyskinesia Abnormalities, Multiple Bronchial Diseases Bronchiectasis Cardiovascular Abnormalities Cardiovascular Diseases Ciliary Motility Disorders Ciliopathies Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dextrocardia Genetic Diseases, Inborn Heart Defects, Congenital Heart Diseases Immotile Cilia Syndrome Kartagener Syndrome Otorhinolaryngologic Diseases Respiratory System Abnormalities Respiratory Tract Diseases Situs Inversus

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hacettepe University

Ankara, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Clinically stable
  • Being able to cooperate with the assessments
  • Not having any orthopedic, or neurological problems

Exclusion criteria

  • Not being clinically stable
  • Not being able to cooperate with the assessments
  • Having any orthopedic, or neurological problems

Treatment and study plan

Data Collection

Other

The first stage of the study:

Retrospective data collection of pulmonary function, respiratory muscle strength, exercise capacity, physical fitness, and activities of daily living (ADL).

The second stage of the study

-Retrospective data of pulmonary function, respiratory muscle function, functional capacity before and after supervised inspiratory muscle training with POWERbreathe K5 device using tapered flow resistive loading and airway clearance techniques performed for 6 weeks in PCD with decreased respiratory muscle strength.

Primary outcomes

  1. A primer outcome for the first stage of the study: Physical fitness

    Time frame: 10 July 2015-10 January 2015-retrospectively

    Munich Physical Fitness Test (MFT) was used to evaluate physical fitness. It is a test with six parameters including ball bounce, sandbag throwing, bending, vertical jumping, hanging and step test.

  2. A primer outcome for the second stage of the study: Functional capacity

    Time frame: 10 July 2015-10 January 2015-retrospectively

    Functional capacity was evaluated with six minute walk test (6MWT).

Secondary outcomes

  1. Demographic features

    Time frame: 10 July 2015-10 January 2015-retrospectively

    The age was recorded in years.

  2. Demographic features

    Time frame: 10 July 2015-10 January 2015-retrospectively

    Weight was recorded in kilograms.

  3. Demographic features

    Time frame: 10 July 2015-10 January 2015-retrospectively

    The length was saved in meters.

  4. Demographic features

    Time frame: 10 July 2015-10 January 2015-retrospectively

    Body mass index was calculated by dividing the weight by the square of the height (kg/m^2) and recorded.

  5. Pulmonary Function

    Time frame: 10 July 2015-10 January 2015-retrospectively

    Pulmonary function (FEV1 (forced expiratory volume in one second), FVC (forced vital capacity), FEV1/FVC, FEF25-75 (%) (forced expiratory volume 25-75 %) and PEF (peak expiratory flow)) assessed with a portable spirometer (Spirobank MIR, Italy).

  6. Respiratory muscle functions

    Time frame: 10 July 2015-10 January 2015-retrospectively

    Respiratory muscle strength (maximal inspiratory pressure (MIP);maximal expiratory pressure (MEP), respectively) was measured with a portable, electronic mouth pressure monitor (Micro Medical MicroMPM, UK) and recorded.

    For second stage of the study; average inspiratory flow, inspiratory volume, and inspiratory work was evaluated based on the outcomes of the Breathe-Link software using POWERbreathe K5 device before and after IMT with tapered flow resistive loading and recorded.

  7. Exercise Capacity

    Time frame: 10 July 2015-10 January 2015-retrospectively

    Exercise capacity was assessed with the modified shuttle walk test.

  8. Activities of Daily Living

    Time frame: 10 July 2015-10 January 2015-retrospectively

    Glittre activities of daily living (ADL) test was used to evaluate daily life activity.

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Sep 10, 2021
Registry last updated
Oct 2, 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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