- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05040607
Physical Fitness, Exercise Capacity and Activities of Daily Living in Primary Ciliary Dyskinesia: a Retrospective Study
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Ankara, Turkey
- Hacettepe University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Patient group: PCD patients consulted from Hacettepe University, Faculty of Medicine, Department of Pediatric Chest Diseases, Child Health and Diseases/, Ankara, Turkey to our unit for evaluation in terms of respiratory physiotherapy were included in our study.
Healthy group: Healthy counterparts from our database of the previous studies were included in our study.
Description
Inclusion Criteria:
- Clinically stable
- Being able to cooperate with the assessments
- Not having any cardiovascular, orthopedic, or neurological problems
Exclusion Criteria:
- Not being clinically stable
- Not being able to cooperate with the assessments
- Having any cardiovascular, orthopedic, or neurological problems
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Primary Ciliary Dyskinesia (PCD)
The first stage of the study: Data of 20 PCD patients from the database recorded between 10 July 2015 and 10 January 2017. The second stage of the study:
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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 collection of pulmonary function, respiratory muscle strength, exercise capacity, physical fitness, and activities of daily living (ADL)
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Healthy Group
Data of 20 healthy subjects from the database recorded between 10 July 2015 and 10 January 2017.
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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 collection of pulmonary function, respiratory muscle strength, exercise capacity, physical fitness, and activities of daily living (ADL)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
A primer outcome for the first stage of the study: Physical fitness
Time Frame: 10 July 2015-10 January 2015-retrospectively
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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.
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10 July 2015-10 January 2015-retrospectively
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A primer outcome for the second stage of the study: Functional capacity
Time Frame: 10 July 2015-10 January 2015-retrospectively
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Functional capacity was evaluated with six minute walk test (6MWT).
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10 July 2015-10 January 2015-retrospectively
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Demographic features
Time Frame: 10 July 2015-10 January 2015-retrospectively
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The age was recorded in years.
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10 July 2015-10 January 2015-retrospectively
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Demographic features
Time Frame: 10 July 2015-10 January 2015-retrospectively
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Weight was recorded in kilograms.
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10 July 2015-10 January 2015-retrospectively
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Demographic features
Time Frame: 10 July 2015-10 January 2015-retrospectively
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The length was saved in meters.
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10 July 2015-10 January 2015-retrospectively
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Demographic features
Time Frame: 10 July 2015-10 January 2015-retrospectively
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Body mass index was calculated by dividing the weight by the square of the height (kg/m^2) and recorded.
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10 July 2015-10 January 2015-retrospectively
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Pulmonary Function
Time Frame: 10 July 2015-10 January 2015-retrospectively
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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).
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10 July 2015-10 January 2015-retrospectively
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Respiratory muscle strength
Time Frame: 10 July 2015-10 January 2015-retrospectively
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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.
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10 July 2015-10 January 2015-retrospectively
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Exercise Capacity
Time Frame: 10 July 2015-10 January 2015-retrospectively
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Exercise capacity was assessed with the modified shuttle walk test.
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10 July 2015-10 January 2015-retrospectively
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Activities of Daily Living
Time Frame: 10 July 2015-10 January 2015-retrospectively
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Glittre activities of daily living (ADL) test was used to evaluate daily life activity.
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10 July 2015-10 January 2015-retrospectively
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Deniz Inal Ince, Prof. Dr., Hacettepe University
- Principal Investigator: Hazal Sonbahar Ulu, MSc, Hacettepe University
- Study Director: Deniz Inal Ince, Prof. Dr., Hacettepe University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Heart Diseases
- Cardiovascular Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Respiratory Tract Diseases
- Neurologic Manifestations
- Disease
- Congenital Abnormalities
- Bronchial Diseases
- Genetic Diseases, Inborn
- Otorhinolaryngologic Diseases
- Movement Disorders
- Heart Defects, Congenital
- Cardiovascular Abnormalities
- Abnormalities, Multiple
- Ciliopathies
- Bronchiectasis
- Respiratory System Abnormalities
- Dextrocardia
- Situs Inversus
- Syndrome
- Dyskinesias
- Ciliary Motility Disorders
- Kartagener Syndrome
Other Study ID Numbers
- GO 19/730
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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