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

Primary Ciliary Dyskinesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05040607
• Other study ID #: GO 19/730
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Ciliary Motility Disorders
• Dyskinesias
• Immotile Cilia Syndrome
• Kartagener Syndrome
• Primary Ciliary Dyskinesia
• Syndrome

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