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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04734743
Other study ID # 2016/06
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2016
Est. completion date November 15, 2016

Study information

Verified date October 2023
Source Hasan Kalyoncu University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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)


Recruitment information / eligibility

Status Completed
Enrollment 63
Est. completion date November 15, 2016
Est. primary completion date November 1, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 15 Years
Eligibility 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 Design


Intervention

Other:
cystic fibrosis
Evaluation of Upper Extremity Muscle Strength and Endurance, functional capacity, Respiratory Function and Quality of Life

Locations

Country Name City State
Turkey Hasan Kalyoncu Universty Gaziantep Sahinbey

Sponsors (1)

Lead Sponsor Collaborator
Cagtay Maden

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 1 day
Primary 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. 1 day
Primary 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 1 day
Primary 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. 1 day
Primary 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. 1 day
Primary Upper Limb muscular endurance The arm pull-up test was used in the evaluation of muscular endurance. 1 day
Primary 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. 1 day
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