Cystic FibrosisNCT04803643
Upper Extremity Exercise Capacity, Muscle Oxygenation, Balance in Patients With Cystic Fibrosis
An observational study of Cystic Fibrosis, run by Gazi University at 2 sites in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Cystic Fibrosis
- How many people
- 60 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 16 Mar 2021to 15 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Gazi University Faculty of Health Science Department of Physiotherapy and Rehabilitation
Ankara, 06500
Gazi University Faculty of Health Sciences Department of Physical Therapy and Rehabilitation
Ankara, Çankaya, 06580
About this study
Official title: 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.
Read the 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.
- Conditions
- Cystic Fibrosis
- Keywords
- cystic fibrosis, upper extremity exercise capacity, muscle oxygenation, balance, physical activity
- Medical subject headings
- Cystic Fibrosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Upper extremity exercise capacity
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.
Measured: First Day
Secondary outcomes (19)
Functional exercise capacity
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.
Measured: First Day
Muscle Oxygenation
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.
Measured: First Day
Balance
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.
Measured: Second Day
Physical activity (Total energy expenditure)
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.
Measured: Second Day
Physical activity (Active energy expenditure (joule / 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.
Measured: Second Day
Physical activity (Physical activity time (min / 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.
Measured: Second Day
Physical activity (Average metabolic equivalent (MET / 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.
Measured: Second Day
Physical activity (Number of steps (steps / 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.
Measured: Second Day
Physical activity (Time spent lying down (min / day) days))
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.
Measured: Second Day
Physical activity (Sleep time (min / 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.
Measured: Second Day
Pulmonary function (Forced vital capacity (FVC))
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.
Measured: First Day
Pulmonary function (Forced expiratory volume in the first second (FEV1))
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.
Measured: First Day
Pulmonary function (FEV1 / FVC)
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.
Measured: First Day
Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%))
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.
Measured: First Day
Pulmonary function (Peak flow rate (PEF))
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.
Measured: First Day
Respiratory muscle strength
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.
Measured: First Day
Peripheral muscle strength
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.
Measured: Second Day
Respiratory muscle endurance
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.
Measured: Second Day
Life quality
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.
Measured: Second Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study start16 Mar 2021
- Primary completion28 Feb 2022
- Study completion15 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meral Boşnak Güçlü, Gazi University
- Investigators
- Betül YOLERİ, Pt, Study chair, Gazi UniversityMeral BOŞNAK GÜÇLÜ, Prof.Dr., Study director, Gazi UniversityAyşe TANA ARSLAN, Prof.Dr., Principal investigator, Gazi UniversityTuğba ŞİŞMANLAR EYÜBOĞLU, Asc. Prof.Dr, Principal investigator, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04803643
- Sponsor's protocol ID
- Gazi University 22
- Status last verified
- Apr 2023
- First submitted
- 3 Mar 2021
- Last updated
- 6 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sharma R, Florea VG, Bolger AP, Doehner W, Florea ND, Coats AJ, Hodson ME, Anker SD, Henein MY. Wasting as an independent predictor of mortality in patients with cystic fibrosis. Thorax. 2001 Oct;56(10):746-50. doi: 10.1136/thorax.56.10.746.
PubMed 11562511Arikan H, Yatar I, Calik-Kutukcu E, Aribas Z, Saglam M, Vardar-Yagli N, Savci S, Inal-Ince D, Ozcelik U, Kiper N. A comparison of respiratory and peripheral muscle strength, functional exercise capacity, activities of daily living and physical fitness in patients with cystic fibrosis and healthy subjects. Res Dev Disabil. 2015 Oct-Nov;45-46:147-56. doi: 10.1016/j.ridd.2015.07.020. Epub 2015 Aug 1.
PubMed 26241869Erickson ML, Seigler N, McKie KT, McCully KK, Harris RA. Skeletal muscle oxidative capacity in patients with cystic fibrosis. Exp Physiol. 2015 Apr 20;100(5):545-52. doi: 10.1113/EP085037.
PubMed 25758606Schneiderman JE, Wilkes DL, Atenafu EG, Nguyen T, Wells GD, Alarie N, Tullis E, Lands LC, Coates AL, Corey M, Ratjen F. Longitudinal relationship between physical activity and lung health in patients with cystic fibrosis. Eur Respir J. 2014 Mar;43(3):817-23. doi: 10.1183/09031936.00055513. Epub 2013 Oct 31.
PubMed 24176992Santana NN, Chaves CRMM, Goncalves CP, Gomes Junior SCDS. FACTORS ASSOCIATED TO QUALITY OF LIFE IN CHILDREN AND ADOLESCENTS WITH CYSTIC FIBROSIS. Rev Paul Pediatr. 2020 Jun 19;38:e2018397. doi: 10.1590/1984-0462/2020/38/2018397. eCollection 2020.
PubMed 32578674
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Upper Extremity Exercise Capacity, Muscle Oxygenation, Balance and Physical Activity Level in Patients With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT04803643
- Acronym / sponsor ID
- Gazi University 22
- Conditions
- Cystic Fibrosis
- Keywords
- cystic fibrosis, upper extremity exercise capacity, muscle oxygenation, balance, physical activity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 16 Mar 2021 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 15 Mar 2022 (actual)
- First posted
- 18 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
19 secondary outcomes
Functional exercise capacity
Time frame: First Day
Muscle Oxygenation
Time frame: First Day
Balance
Time frame: Second Day
Physical activity (Total energy expenditure)
Time frame: Second Day
Physical activity (Active energy expenditure (joule / day))
Time frame: Second Day
Physical activity (Physical activity time (min / day))
Time frame: Second Day
Physical activity (Average metabolic equivalent (MET / day))
Time frame: Second Day
Physical activity (Number of steps (steps / day))
Time frame: Second Day
Physical activity (Time spent lying down (min / day) days))
Time frame: Second Day
Physical activity (Sleep time (min / day))
Time frame: Second Day
Pulmonary function (Forced vital capacity (FVC))
Time frame: First Day
Pulmonary function (Forced expiratory volume in the first second (FEV1))
Time frame: First Day
Pulmonary function (FEV1 / FVC)
Time frame: First Day
Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%))
Time frame: First Day
Pulmonary function (Peak flow rate (PEF))
Time frame: First Day
Respiratory muscle strength
Time frame: First Day
Peripheral muscle strength
Time frame: Second Day
Respiratory muscle endurance
Time frame: Second Day
Life quality
Time frame: Second Day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
- Background: PubMed 11562511Sharma R, Florea VG, Bolger AP, Doehner W, Florea ND, Coats AJ, Hodson ME, Anker SD, Henein MY. Wasting as an independent predictor of mortality in patients with cystic fibrosis. Thorax. 2001 Oct;56(10):746-50. doi: 10.1136/thorax.56.10.746.
- Background: PubMed 26241869Arikan H, Yatar I, Calik-Kutukcu E, Aribas Z, Saglam M, Vardar-Yagli N, Savci S, Inal-Ince D, Ozcelik U, Kiper N. A comparison of respiratory and peripheral muscle strength, functional exercise capacity, activities of daily living and physical fitness in patients with cystic fibrosis and healthy subjects. Res Dev Disabil. 2015 Oct-Nov;45-46:147-56. doi: 10.1016/j.ridd.2015.07.020. Epub 2015 Aug 1.
- Background: PubMed 25758606Erickson ML, Seigler N, McKie KT, McCully KK, Harris RA. Skeletal muscle oxidative capacity in patients with cystic fibrosis. Exp Physiol. 2015 Apr 20;100(5):545-52. doi: 10.1113/EP085037.
- Background: PubMed 24176992Schneiderman JE, Wilkes DL, Atenafu EG, Nguyen T, Wells GD, Alarie N, Tullis E, Lands LC, Coates AL, Corey M, Ratjen F. Longitudinal relationship between physical activity and lung health in patients with cystic fibrosis. Eur Respir J. 2014 Mar;43(3):817-23. doi: 10.1183/09031936.00055513. Epub 2013 Oct 31.
- Background: PubMed 32578674Santana NN, Chaves CRMM, Goncalves CP, Gomes Junior SCDS. FACTORS ASSOCIATED TO QUALITY OF LIFE IN CHILDREN AND ADOLESCENTS WITH CYSTIC FIBROSIS. Rev Paul Pediatr. 2020 Jun 19;38:e2018397. doi: 10.1590/1984-0462/2020/38/2018397. eCollection 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Betül YOLERİ, Pt study chair
Gazi University
Meral BOŞNAK GÜÇLÜ, Prof.Dr. study director
Gazi University
Ayşe TANA ARSLAN, Prof.Dr. principal investigator
Gazi University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis, run by Gazi University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Upper extremity exercise capacity (time frame: First Day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04803643, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2023.