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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05040607
Other study ID # GO 19/730
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 21, 2020
Est. completion date February 10, 2020

Study information

Verified date April 2023
Source Hacettepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 48
Est. completion date February 10, 2020
Est. primary completion date February 10, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 8 Years to 18 Years
Eligibility 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 Design


Intervention

Other:
Data Collection
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 strength, functional capacity before and after supervised inspiratory muscle training with POWERbreathe K5 device and airway clearance techniques performed for 6 weeks in PCD with decreased respiratory muscle strength (Intervention Group). Retrospective data of pulmonary function, respiratory muscle strength, and functional capacity before and after airway clearance techniques performed for 6 weeks as home-based therapy in PCD with decreased respiratory muscle strength (Control group).
Data Collection
-Retrospective data collection of pulmonary function, respiratory muscle strength, exercise capacity, physical fitness, and activities of daily living (ADL)

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 A primer outcome for the first stage of the study: Physical fitness 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. 10 July 2015-10 January 2015-retrospectively
Primary A primer outcome for the second stage of the study: Functional capacity Functional capacity was evaluated with six minute walk test (6MWT). 10 July 2015-10 January 2015-retrospectively
Secondary Demographic features The age was recorded in years. 10 July 2015-10 January 2015-retrospectively
Secondary Demographic features Weight was recorded in kilograms. 10 July 2015-10 January 2015-retrospectively
Secondary Demographic features The length was saved in meters. 10 July 2015-10 January 2015-retrospectively
Secondary Demographic features Body mass index was calculated by dividing the weight by the square of the height (kg/m^2) and recorded. 10 July 2015-10 January 2015-retrospectively
Secondary Pulmonary Function 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). 10 July 2015-10 January 2015-retrospectively
Secondary Respiratory muscle strength 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. 10 July 2015-10 January 2015-retrospectively
Secondary Exercise Capacity Exercise capacity was assessed with the modified shuttle walk test. 10 July 2015-10 January 2015-retrospectively
Secondary Activities of Daily Living Glittre activities of daily living (ADL) test was used to evaluate daily life activity. 10 July 2015-10 January 2015-retrospectively
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