Upper Extremity Exercise Capacity, Muscle Oxygenation, Balance in Patients With Cystic Fibrosis

April 4, 2023 updated by: Meral Boşnak Güçlü, Gazi University

Investigation of Upper Extremity Exercise Capacity, Muscle Oxygenation, Balance and Physical Activity Level in Patients With Cystic Fibrosis

The primary aim of the study is to evaluate upper extremity exercise capacity, muscle oxygenation, balance and physical activity level in patients with cystic fibrosis.. The secondary aim of the study is assessment of functional exercise capacity, respiratory function, peripheral and respiratory muscle strength, respiratory muscle endurance, quality of life in patients with cystic fibrosis and compare them with healthy controls.

Study Overview

Status

Completed

Conditions

Detailed Description

Cystic fibrosis (CF) is an autosomal recessive genetic disease. Although it is a monogenetic type of disease, its phenotype varies widely. CF is characterized by progressive lung disease, malabsorption of fat and protein, fatty stools, pancreatic insufficiency resulting in gastrointestinal malabsorption, intestinal abnormalities resulting in malnutrition, growth retardation, sinusitis, and diabetes. The most important problems seen in patients are excessive secretion, decreased exercise capacity, dyspnea and muscle strength loss. Exercise capacity, respiratory functions, respiratory and peripheral muscle strength, respiratory muscle endurance, balance, physical activity, quality of life are poor in cystic fibrosis patients.There are insufficient studies on this subject in the literature. The number of studies using objective method is few. Cystic fibrosis patients have upper extremity muscle weakness. There is no study on the evaluation of upper extremity exercise capacity in these patients in the literature. Even if patients with CF have normal pulmonary function test results, there are studies showing that exercise intolerance has developed. These reasons have revealed the need to investigate oxygen metabolism at the cellular level.There are only two studies in the literature evaluating muscle oxygenation in patients with cystic fibrosis. There is no study evaluating with a "Moxy" monitor.The primary aim of the study is to evaluate upper extremity exercise capacity, muscle oxygenation, balance and physical activity level in patients with cystic fibrosis.. The secondary aim of the study is assessment of functional exercise capacity, respiratory function, peripheral and respiratory muscle strength, respiratory muscle endurance, quality of life in patients with cystic fibrosis and compare them with healthy controls.

The study was planned cross-sectional. At least 30 cystic fibrosis patients and 30 age- and sex-matched healthy controls will be included in the study. Individuals' exercise capacity, respiratory functions, physical activity levels, balance assessments, peripheral and respiratory muscle strength, respiratory muscle endurance, muscle oxygenation and quality of life will be evaluated. Upper extremity exercise capacity will be assessed using six minute pegboard ring test, functional exercise capacity using six minute walk test, muscle oxygenation using "Moxy" monitor, balance using "Biodex Balance System®" and Y balance test, physical activity using multi-sensor activity monitor, pulmonary function using spirometry, respiratory muscle strength using mouth pressure device, peripheral muscle strength using hand held dynamometer, respiratory muscle endurance using incremental threshold loading test, life quality using "The Revised Cystic Fibrosis Questionnaire (CFQ-R)" (Turkish version). The assessments will be completed in two days.

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Ankara, Turkey, 06500
        • Gazi University Faculty of Health Science Department of Physiotherapy and Rehabilitation
    • Çankaya
      • Ankara, Çankaya, Turkey, 06580
        • Gazi University Faculty of Health Sciences Department of Physical Therapy and Rehabilitation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

At least 30 patients with cystic fibroisis will be included in patients group and 30 healthy individuals will be included in control group

Description

Inclusion Criteria:

Patients;

  • 6-18 years old
  • Diagnosed with cystic fibrosis according to the American Cystic Fibrosis Association consensus report criteria
  • Those who have not participated in the exercise training program planned in the last 3 months

Healthy controls;

  • 6-18 years old

Exclusion Criteria:

Patients;

  • A history of lung or liver transplant
  • Diagnosed vision, hearing, vestibular, or neurological problems that can affect balance
  • History of hospitalization previously (1 month)
  • History of coronavirus disease (COVID-19)
  • History of smoking
  • Diagnosed orthopedic problems affecting mobility or a history of musculoskeletal surgery
  • Acute pulmonary exacerbation
  • Diagnosed with allergic
  • Bronchopulmonary aspergillosis
  • Systemic corticosteroids use
  • Pulmonary hypertension and cardiovascular instability

Healthy controls;

  • Trouble understanding and following the exercise test instruction
  • A history of smoking

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients
Upper extremity exercise capacity will be assessed using six minute pegboard ring test, functional exercise capacity using six minute walk test, muscle oxygenation using "Moxy" monitor, balance using "Biodex Balance System®" and Y balance test, physical activity using multi-sensor activity monitor, pulmonary function using spirometry, respiratory muscle strength using mouth pressure device, peripheral muscle strength using hand held dynamometer, respiratory muscle endurance using incremental threshold loading test, life quality using "The Revised Cystic Fibrosis Questionnaire (CFQ-R)" (Turkish version).
Healthy controls
Upper extremity exercise capacity will be assessed using six minute pegboard ring test, functional exercise capacity using six minute walk test, muscle oxygenation using "Moxy" monitor, balance using "Biodex Balance System®" and Y balance test, physical activity using multi-sensor activity monitor, pulmonary function using spirometry, respiratory muscle strength using mouth pressure device, peripheral muscle strength using hand held dynamometer, respiratory muscle endurance using incremental threshold loading test, life quality using "The Revised Cystic Fibrosis Questionnaire (CFQ-R)" (Turkish version).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Upper extremity exercise capacity
Time Frame: First Day
Upper extremity exercise capacity will be evaluated with the 6-Minute Pegboard and Ring Test (Total number of rings). There are a total of 20 rings on the 4 iron bars on the board to be used. Patients will be asked to wear the rings with both hands first from top to bottom and then from bottom to top. At the end of 6 minutes, the total attached ring will be recorded in terms of pieces.
First Day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical activity (Total energy expenditure)
Time Frame: Second Day
Physical activity will be evaluated with the Multi sensor activity monitor (SenseWear®, Inc Pittsburgh, ABD). The patient will wear the multisensor physical activity monitor over the triceps muscle of the non-dominant arm for 3 continuous days. The patient will be informed about removing the device while taking a bath. Total energy expenditure (joule / day) will be measured with the multi-sensor physical activity monitor. The parameters measured over two days will be averaged and analyzed with the "SenseWear® 7.0 Software" program.
Second Day
Physical activity (Physical activity time (min / day))
Time Frame: Second Day
Physical activity will be evaluated with the Multi sensor activity monitor (SenseWear®, Inc Pittsburgh, ABD). The patient will wear the multisensor physical activity monitor over the triceps muscle of the non-dominant arm for 3 continuous days. The patient will be informed about removing the device while taking a bath. Physical activity time (min / day)will be measured with the multi-sensor physical activity monitor. The parameters measured over two days will be averaged and analyzed with the "SenseWear® 7.0 Software" program.
Second Day
Physical activity (Active energy expenditure (joule / day))
Time Frame: Second Day
Physical activity will be evaluated with the Multi sensor activity monitor (SenseWear®, Inc Pittsburgh, ABD). The patient will wear the multisensor physical activity monitor over the triceps muscle of the non-dominant arm for 3 continuous days. The patient will be informed about removing the device while taking a bath. Active energy expenditure (joule / day) will be measured with the multi-sensor physical activity monitor. The parameters measured over two days will be averaged and analyzed with the "SenseWear® 7.0 Software" program.
Second Day
Physical activity (Average metabolic equivalent (MET / day))
Time Frame: Second Day
Physical activity will be evaluated with the Multi sensor activity monitor (SenseWear®, Inc Pittsburgh, ABD). The patient will wear the multisensor physical activity monitor over the triceps muscle of the non-dominant arm for 3 continuous days. The patient will be informed about removing the device while taking a bath. Average metabolic equivalent (MET / day) will be measured with the multi-sensor physical activity monitor. The parameters measured over two days will be averaged and analyzed with the "SenseWear® 7.0 Software" program.
Second Day
Physical activity (Number of steps (steps / day))
Time Frame: Second Day
Physical activity will be evaluated with the Multi sensor activity monitor (SenseWear®, Inc Pittsburgh, ABD). The patient will wear the multisensor physical activity monitor over the triceps muscle of the non-dominant arm for 3 continuous days. The patient will be informed about removing the device while taking a bath. Number of steps (steps / day) will be measured with the multi-sensor physical activity monitor. The parameters measured over two days will be averaged and analyzed with the "SenseWear® 7.0 Software" program.
Second Day
Physical activity (Time spent lying down (min / day) days))
Time Frame: Second Day
Physical activity will be evaluated with the Multi sensor activity monitor (SenseWear®, Inc Pittsburgh, ABD). The patient will wear the multisensor physical activity monitor over the triceps muscle of the non-dominant arm for 3 continuous days. The patient will be informed about removing the device while taking a bath. Time spent lying down (min / day) days) will be measured with the multi-sensor physical activity monitor. The parameters measured over two days will be averaged and analyzed with the "SenseWear® 7.0 Software" program.
Second Day
Physical activity (Sleep time (min / day))
Time Frame: Second Day
Physical activity will be evaluated with the Multi sensor activity monitor (SenseWear®, Inc Pittsburgh, ABD). The patient will wear the multisensor physical activity monitor over the triceps muscle of the non-dominant arm for 3 continuous days. The patient will be informed about removing the device while taking a bath. Sleep time (min / day) will be measured with the multi-sensor physical activity monitor. The parameters measured over two days will be averaged and analyzed with the "SenseWear® 7.0 Software" program.
Second Day
Functional exercise capacity
Time Frame: First Day
Functional exercise capacity will be evaluated with the 6- Minute Walk Test. 6- Minute Walk Test will be applied according to the American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria.
First Day
Muscle Oxygenation
Time Frame: First Day
Muscle oxygenation will be evaluated with the "Moxy" monitor (Moxy, Fortiori Design LLC, Minnesota, ABD). For measurement, "Moxy monitor" will be placed bilaterally at the 1/3 lower motor point of the quadriceps muscle group and on the deltoid muscle. A minimum of 3 minutes will be waited until the resting measurements and the skeletal muscle oxygenation (StO2) signal stabilize. The values (StO2 and total hemoglobin) will be recorded after the 6-minute walking test and the 6-Minute Pegboard and Ring Test. Data will be analyzed appropriately.
First Day
Balance
Time Frame: Second Day
Static balance will be evaluated with the "Biodex Balance System®". Dynamic balance will be evaluated with the Y balance test. The data obtained from the system as a result of the test will be the general stability index, anterior / posterior (AP) stability index, medial / lateral (ML) stability index and their standard deviations. The tests will first be carried out on the hard ground with open eyes and then repeated on the soft ground. The measurements will then be repeated with eyes closed on hard and soft ground.
Second Day
Pulmonary function (Forced vital capacity (FVC))
Time Frame: First Day
Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to ATS and ERS criteria. With the device, forced vital capacity (FVC) will be evaluated.
First Day
Pulmonary function (Forced expiratory volume in the first second (FEV1))
Time Frame: First Day
Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to ATS and ERS criteria. With the device, forced expiratory volume in the first second (FEV1) will be evaluated.
First Day
Pulmonary function (FEV1 / FVC)
Time Frame: First Day
Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to ATS and ERS criteria. With the device, FEV1 / FVC will be evaluated.
First Day
Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%))
Time Frame: First Day
Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to ATS and ERS criteria. With the device, flow rate 25-75% of forced expiratory volume (FEF 25-75%) will be evaluated.
First Day
Pulmonary function (Peak flow rate (PEF))
Time Frame: First Day
Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to ATS and ERS criteria. With the device, peak flow rate (PEF) will be evaluated.
First Day
Respiratory muscle strength
Time Frame: First Day
Maximal inspiratory (MIP) and maximal expiratory (MEP) pressures expressing respiratory muscle strength will be measured with a portable mouth pressure measuring device according to ATS and ERS criteria.
First Day
Peripheral muscle strength
Time Frame: Second Day
Isometric peripheral muscle strength will be measured with a portable hand dynamometer (JTECH Commander, USA). Measurements will be repeated on the shoulder abductors and knee extensors three times on the right and left.
Second Day
Respiratory muscle endurance
Time Frame: Second Day
Respiratory muscle endurance will be assessed by the POWERbreathe Wellness (POWERbreathe, Inspiratory Muscle Training (IMT) Technologies Ltd., Birmingham, UK) device and the respiratory muscle endurance test at increased threshold load. The test will be started with 20% of the maximal inspiratory pressure and the pressure will be increased to 40%, 60%, 80% and 100% every two minutes. Patients will be asked to continue breathing through the device during the test. During the test, the number of breaths delivered and the maximal time reached during each 2-minute period will be recorded. If the individual cannot breathe 3 consecutive times, the test will be terminated by the physiotherapist. The total duration of the test and the maximum pressure value at which it continues to breathe for at least 1 minute will be multiplied. The value found will be recorded as the respiratory muscle endurance value.
Second Day
Life quality
Time Frame: Second Day
Quality of life will be evaluated with the Turkish adaptation of the Revised Cystic Fibrosis Questionnaire (CFQ-R). The scale have well-established reliability and validity. There are four CFQ-R questionnaires for patients of three different age groups (6-10, 12-13, and 14 years and older). The CFQ-R children's version consists of 35 questions. Scale subtitles; It consists of physical functioning, emotional functioning, social functioning, body ımage, eating disorders, treatment burden, and respiratory and digestive symptoms. Items for child CFQ-R are rated according to a 4-point scale. Higher scores indicate better quality of life.
Second Day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Ayşe TANA ARSLAN, Prof.Dr., Gazi University
  • Study Chair: Betül YOLERİ, Pt, Gazi University
  • Principal Investigator: Tuğba ŞİŞMANLAR EYÜBOĞLU, Asc. Prof.Dr, Gazi University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 16, 2021

Primary Completion (Actual)

February 28, 2022

Study Completion (Actual)

March 15, 2022

Study Registration Dates

First Submitted

March 3, 2021

First Submitted That Met QC Criteria

March 17, 2021

First Posted (Actual)

March 18, 2021

Study Record Updates

Last Update Posted (Actual)

April 6, 2023

Last Update Submitted That Met QC Criteria

April 4, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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