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NCT Number: NCT04734743

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

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

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Key information

Conditions

Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Exercise Tolerance Functional Capacity Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Muscle Strength Muscular Endurance Pancreatic Diseases Pulmonary Function Respiratory Tract Diseases

Age range

6 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hasan Kalyoncu Universty

Gaziantep, Şahinbey, Turkey (Türkiye)

About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

cystic fibrosis

Other

Evaluation of Upper Extremity Muscle Strength and Endurance, functional capacity, Respiratory Function and Quality of Life

Primary outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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.

  5. 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.

  6. Upper Limb muscular endurance

    Time frame: 1 day

    The arm pull-up test was used in the evaluation of muscular endurance.

  7. 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.

Sponsors and collaborators

Lead sponsor

Cagtay Maden

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Feb 2, 2021
Registry last updated
Oct 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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