- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04734743
Muscle Strength, Functional Capacity, Respiratory Function and Quality Of Life In Cystic Fibrosis Patients
October 17, 2023 updated by: Cagtay Maden, Çağtay Maden
Upper Extremity Muscle Strength and Endurance, Functional Capacity, Respiratory Function and Quality of Life in Child and Adolescent With Cystic Fibrosis
This study was designed to investigate the relationship between upper extremity muscle strength and endurance, functional capacity, and quality of life child and adolescent with cystic fibrosis
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Child and adolescent with cystic fibrosis patients were assessed for upper extremity muscle strength and (Shoulder abductors muscle strength, Elbow flexion muscle strength, Handgrip strength) muscular endurance(arm pull-up test), lung function test, and functional capacity (six-minute walk test distance), and Quality Of Life (Cystic Fibrosis Questionnaire-Revised)
Study Type
Interventional
Enrollment (Actual)
63
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Şahinbey
-
Gaziantep, Şahinbey, Turkey
- Hasan Kalyoncu Universty
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 15 years (Child)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Individuals diagnosed with CF with clinical findings and gene mutations consistent with CF, having over 60mEq / L in two measurements in sweat chlorine examinations
Exclusion Criteria:
- Patients who did not exacerbate the disease in the last four weeks, who had good cooperation and did not have any orthopedic problems in the hand-shoulder-arm complex were included.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Cystic fibrosis
|
Evaluation of Upper Extremity Muscle Strength and Endurance, functional capacity, Respiratory Function and Quality of Life
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Forced Expiratory Volume in 1 Second (FEV1)
Time Frame: 1 day
|
Pulmonary function tests were evaluated with a spirometer.
It is the volume of air released in the first second from the beginning of the difficult vital capacity maneuver.
In general, it gives information about the restriction in major airlines.
FEV1 / FVC ratio decrease shows obstruction, FEV1 shows the severity of obstruction.
|
1 day
|
|
Six-minute walk test
Time Frame: 1 day
|
In the 6-minute walk test (6MWT), subjects were asked to walk as fast as they could walk within 6 minutes along a 30-meter straight corridor.
The test was performed twice within the same day at intervals of half an hour.
The longer distance value for each patient from the two tests used was used for statistical analysis.
|
1 day
|
|
Forced Vital Capacity (FVC)
Time Frame: 1 day
|
Pulmonary function tests were evaluated with a spirometer.
It is the volume of air that comes out with rapid and powerful exhalation following deep inspiratory.
Healthy people can normally extract 80 percent of their lung volume in 6 seconds or less
|
1 day
|
|
Peak Expiratory Flow (PEF)
Time Frame: 1 day
|
Pulmonary function tests were evaluated with a spirometer.
It is measured by the maximum exhalation maneuver following the maximum inspiration.
It gives information about obstruction in large airways.
|
1 day
|
|
Upper Limb Muscle Strength
Time Frame: 1 day
|
Evaluation of peripheral muscle strength Deltoideus (shoulder abduction), Biceps Brachii (elbow flexion) muscles were evaluated with a digital dynamometer (Lafeyette manual muscle tester, U.S.A).
Handgrip strength was measured by a hand dynamometer (Baseline LITE hand dynamometer, U.S.A).
In each muscle test, the right and left sides were evaluated separately and repeated three times and the best values obtained were recorded in Newton (N).
Arithmetic means of the right and left sides were used for statistical analysis.
|
1 day
|
|
Upper Limb muscular endurance
Time Frame: 1 day
|
The arm pull-up test was used in the evaluation of muscular endurance.
|
1 day
|
|
Ouality of Life
Time Frame: 1 day
|
Cystic Fibrosis Questionnaire-Revised (CFQ-R) was used to evaluate the quality of life.
There are four CFQ-R questionnaires for parents of children aged 6 years and over, three different age groups [6-10, 12-13, and over).
The child's version of CFQ-R consists of 35 questions in 8 parts, Physical Functioning, Emotional Functioning, Social Functioning, Body Image, Eating Disturbances, Treatment Burden, Respiratory symptoms, and Digestive symptoms.
Its values range from 0 to 100 points and the higher the score, the better quality of life.
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Çağtay maden, MSc, Pt, Hasan Kalyoncu University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2016
Primary Completion (Actual)
November 1, 2016
Study Completion (Actual)
November 15, 2016
Study Registration Dates
First Submitted
January 28, 2021
First Submitted That Met QC Criteria
January 28, 2021
First Posted (Actual)
February 2, 2021
Study Record Updates
Last Update Posted (Actual)
October 18, 2023
Last Update Submitted That Met QC Criteria
October 17, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016/06
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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