Muscle Strength, Functional Capacity, Respiratory Function and Quality Of Life In Cystic Fibrosis Patients

Cystic Fibrosis Clinical Trial

Official title:

Upper Extremity Muscle Strength and Endurance, Functional Capacity, Respiratory Function and Quality of Life in Child and Adolescent With Cystic Fibrosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04734743
• Other study ID #: 2016/06
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Cystic Fibrosis
• Exercise Tolerance
• Fibrosis
• Functional Capacity
• Muscle Strength
• Muscular Endurance
• Pulmonary Function

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