Back to resultsMuscle Strength, Functional Capacity, Respiratory Function and Quality Of Life In Cystic Fibrosis Patients
Primary Purpose
Cystic Fibrosis, Muscle Strength, Pulmonary Function
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
cystic fibrosis
Sponsored by
About this trial
This is an interventional other trial for Cystic Fibrosis focused on measuring muscle strength, pulmonary function, Cystic Fibrosis, functional capacity
Eligibility Criteria
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.
Sites / Locations
- Hasan Kalyoncu Universty
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Cystic fibrosis
Arm Description
Outcomes
Primary Outcome Measures
Forced Expiratory Volume in 1 Second (FEV1)
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.
Six-minute walk test
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.
Forced Vital Capacity (FVC)
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
Peak Expiratory Flow (PEF)
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.
Upper Limb Muscle Strength
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.
Upper Limb muscular endurance
The arm pull-up test was used in the evaluation of muscular endurance.
Ouality of Life
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04734743
Brief Title
Muscle Strength, Functional Capacity, Respiratory Function and Quality Of Life In Cystic Fibrosis Patients
Official Title
Upper Extremity Muscle Strength and Endurance, Functional Capacity, Respiratory Function and Quality of Life in Child and Adolescent With Cystic Fibrosis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
May 1, 2016 (Actual)
Primary Completion Date
November 1, 2016 (Actual)
Study Completion Date
November 15, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Cagtay Maden
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis, Muscle Strength, Pulmonary Function, Functional Capacity, Exercise Tolerance, Muscular Endurance
Keywords
muscle strength, pulmonary function, Cystic Fibrosis, functional capacity
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
63 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cystic fibrosis
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
cystic fibrosis
Intervention Description
Evaluation of Upper Extremity Muscle Strength and Endurance, functional capacity, Respiratory Function and Quality of Life
Primary Outcome Measure Information:
Title
Forced Expiratory Volume in 1 Second (FEV1)
Description
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.
Time Frame
1 day
Title
Six-minute walk test
Description
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.
Time Frame
1 day
Title
Forced Vital Capacity (FVC)
Description
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
Time Frame
1 day
Title
Peak Expiratory Flow (PEF)
Description
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.
Time Frame
1 day
Title
Upper Limb Muscle Strength
Description
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.
Time Frame
1 day
Title
Upper Limb muscular endurance
Description
The arm pull-up test was used in the evaluation of muscular endurance.
Time Frame
1 day
Title
Ouality of Life
Description
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.
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Çağtay maden, MSc, Pt
Organizational Affiliation
Hasan Kalyoncu University
Official's Role
Study Director
Facility Information:
Facility Name
Hasan Kalyoncu Universty
City
Gaziantep
State/Province
Şahinbey
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
Muscle Strength, Functional Capacity, Respiratory Function and Quality Of Life In Cystic Fibrosis Patients
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