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

NCT04734743 | Completed

• 1 other identifier: 2016/06
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

muscle strength; pulmonary function; Cystic Fibrosis; functional capacity

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• 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

• 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

• 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

• Upper Limb muscular endurance

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

  1 day

• 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

Study Arms (1)

Cystic fibrosis

OTHER

Other: cystic fibrosis

Interventions

cystic fibrosis OTHER

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

Cystic fibrosis

Eligibility Criteria

• Age: 6 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Individuals diagnosed with CF with clinical findings and gene mutations consistent with CF, having over 60mEq / L in two measurements in sweat chlorine examinations

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cagtay Maden: lead

Study Sites (1)

Hasan Kalyoncu Universty

Gaziantep, Şahinbey, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Çağtay maden, MSc, Pt

  Hasan Kalyoncu University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, physiotherapist

Study Record Dates

• First Submitted: January 28, 2021
• First Posted: February 2, 2021
• Study Start: May 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: November 15, 2016
• Last Updated: October 18, 2023

Record last verified: 2023-10

Locations

TU (1)