Pulmonary Arterial HypertensionNCT06454838
Exercise Capacity Muscle Oxygenation and Arterial Stiffness in Children With Pulmonary Arterial Hypertension
An observational study of Pulmonary Arterial Hypertension, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
The primary aim is to evaluate pulmonary function, respiratory muscle strength, upper and lower extremity exercise capacity, muscle oxygenation, dyspnea, peripheral muscle strength, arterial stiffness, physical activity level and balance in children with pulmonary arterial hypertension and compare with age- and… Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Arterial Hypertension
- How many people
- 26 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Apr 2024to 30 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 13 children with PAH and 13 age- and sex- matched healthy controls will be included in the study.
Who may be able to join
- Patients:
- Between the ages of 6-18
- Diagnosed with pulmonary arterial hypertension
- Stability of clinical condition and receiving standard medical treatment
- Healthy controls:
- Between the ages of 6-18
- Willing to participate in the study
Who cannot join
- Patients:
- Having any acute infection, orthopedic, neurological, cooperation, vision or hearing problems that may prevent during the measurements
- Participated in a planned exercise program in a last three months
- Healthy controls:
- Having any acute or chronic illness
- Active or ex-smoker
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ece BAYTOK, Pt. MSc. contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Gazi University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation, Cardiopulmonary Rehabilitation Unit
Ankara, Çankaya, 06490
Meral BOŞNAK GÜÇLÜ, Prof. Dr., +90312 216 2647, meralbosnak@gazi.edu.tr
Ece BAYTOK, MsC, 05554887758, ecebaytok@gmail.com
About this study
The primary aim is to evaluate pulmonary function, respiratory muscle strength, upper and lower extremity exercise capacity, muscle oxygenation, dyspnea, peripheral muscle strength, arterial stiffness, physical activity level and balance in children with pulmonary arterial hypertension and compare with age- and sex-matched healthy controls.
The second aim is to investigate the relationship between upper extremity exercise capacity, arterial stiffness, respiratory and peripheral muscle strength
Read the detailed description
Pulmonary arterial hypertension (PAH) is defined as higher than 25 mmHg in mean pulmonary arterial pressure at rest. Pulmonary arterial hypertension is chronic and progressive disease.
Symptoms such as dyspnea, fatigue, exercise intolerance, cyanosis and syncope are shown in children with PAH. Most common symptom is dyspnea during exertion. Dyspnea at rest could occur while the severity of disease is progressed. All these symptoms have been associated with decreased cardiac output and mismatch oxygen transport.
This study is planned as a cross-sectional study. At least 13 children with PAH and at least 13 age- and sex- matched healthy controls will be included in this study. Individuals' pulmonary function (spirometer), respiratory muscle strength (mouth pressure device), upper extremity exercise capacity (the six minute Peg Board Ring Test), lower extremity exercise capacity (six minute walk test), muscle oxygenation ('Moxy' monitor device), dyspnea (modified Borg Scale), peripheral muscle strength (hand-held dynamometer), arterial stiffness (arteriograph device), physical activity level (multi-sensor activity monitor) and static balance (balance system with computed) will evaluated in children with PAH and healthy controls. All assessments will be completed in two days.
- Conditions
- Pulmonary Arterial Hypertension
- Keywords
- Upper Extremity Exercise Capacity, Muscle Oxygenation, Arterial Stiffness, Respiratory Muscle Strength
- Medical subject headings
- Pulmonary Arterial Hypertension
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 |
|---|---|---|
| Children with pulmonary arterial hypertension | Pulmonary function (spirometer), respiratory muscle strength (mouth pressure device), upper extremity exercise capacity (Six minutes PegBoard Ring Test) and lower extremity exercise capacity (Six minutes walk test), muscle oxygenation ('Moxy' monitor device), dyspnea (modified Borg Scale), peripheral muscle strength (hand-held dynamometer), arterial stiffness (arteriograph), physical activity level (multi-sensor activity monitor) and static balance (balance system with computed) will be evaluated. | |
| Age- and sex- matched healthy controls | Pulmonary function (spirometer), respiratory muscle strength (mouth pressure device), upper extremity exercise capacity (Six minutes PegBoard Ring Test) and lower extremity exercise capacity (Six minutes walk test), muscle oxygenation ('Moxy' monitor device), dyspnea (modified Borg Scale), peripheral muscle strength (hand-held dynamometer), arterial stiffness (arteriograph), physical activity level (multi-sensor activity monitor) and static balance (balance system with computed) will be evaluated. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper extremity exercise capacity
Six minutes PegBoard and Ring Test (6-PBRT) will be applied to evaluate upper extremity exercise capacity. There are a total of 20 rings and 2 wooden bars at above and 2 wooden bars at below. Patients will be asked to move the each two rings from upper bars to lower bars and than from lower bars to upper bars with hands as fast as.
The total number of rings moved during the test will be recorded at the end of test.
Measured: First day
Muscle oxygenation
Muscle oxygenation will be evaluated with the Moxy monitor (Moxy, Fortiori Design LLC, Minnesota, USA) as a non-invasive. The device will be attached with soft tape on the participants' skin surface.
The device will be placed on the 1/3 lower motor point of the deltoid muscle group of the dominant arm during the the six minutes PegBoard and Ring Test and placed on the 1/3 lower motor point of the quadriceps muscle of dominant leg during the six minutes walk test. At rest and during the test, skeletal muscle oxygenation (StO2) and total hemoglobin (THb) values will be recorded.
Measured: First day
Secondary outcomes (18)
Respiratory muscle strength
Maximal inspiratory (MIP) and maximal expiratory (MEP) pressures expressing respiratory muscle strength will be evaluated using a portable mouth pressure device. Measurements will be applied according to American Thoracic Society and European Respiratory Society criteria.
Measured: First day
Peripheral muscle strength
Isometric peripheral muscle strength of quadriceps and deltoid muscles will be measured with a portable hand-held dynamometer (JTECH Commander, USA). Measurements will be repeated three times for both extremities.
Measured: Second day
Dyspnea
Perception of dyspnea at rest and during the activities of daily living will be assessed with modified Borg scale. The scale is graded between '0' and '10'. The lower score for dyspnea means 'no shortness of breath' and higher score for dyspnea means 'very very hard'.
Measured: Second day
Lower extremity exercise capacity
Six minute walk test (6-MWT) will be used to evaluate lower extremity exercise capacity. The test will be applied based on American Thoracic Society and European Respiratory Society criteria. The longest walking distance will be recorded to analyze.
Measured: Second day
Physical activity (Total energy expenditure)
Total energy expenditure, one of the parameters of physical activity, will be evaluated with multisensor activity monitor (SenseWear®, Inc Pittsburgh, ABD). The patient will wear the multisensor physical activity monitor over the triceps muscle of the right arm for 3 continuous days. Total energy expenditure will be expressed as joule/day. The parameter measured over two days will be averaged and analyzed with the "SenseWear® 7.0 Software" program.
Measured: Second day
Physical activity (Active energy expenditure)
Active energy expenditure, one of the parameters of physical activity, will be evaluated with multisensor activity monitor (SenseWear®, Inc Pittsburgh, ABD). The patient will wear the multisensor physical activity monitor over the triceps muscle of the right arm for 3 continuous days. Active energy expenditure will be expressed as joule/day. The parameter measured over two days will be averaged and analyzed with the "SenseWear® 7.0 Software" program.
Measured: Second day
Physical activity (Physical activity duration)
Physical activity duration, one of the parameters of physical activity, will be evaluated with multisensor activity monitor (SenseWear®, Inc Pittsburgh, ABD). The patient will wear the multisensor physical activity monitor over the triceps muscle of the right arm for 3 continuous days. Physical activity duration will be expressed as minute/day. The parameter measured over two days will be averaged and analyzed with the "SenseWear® 7.0 Software" program.
Measured: Second day
Physical activity (Average metabolic equivalent)
Average metabolic equivalent, one of the parameters of physical activity, will be evaluated with multisensor activity monitor (SenseWear®, Inc Pittsburgh, ABD). The patient will wear the multisensor physical activity monitor over the triceps muscle of the right arm for 3 continuous days. The parameter measured over two days will be averaged and analyzed with the "SenseWear® 7.0 Software" program.
Measured: Second day
Physical activity (Number of steps)
Number of steps, one of the parameters of physical activity, will be evaluated with multisensor activity monitor (SenseWear®, Inc Pittsburgh, ABD). The patient will wear the multisensor physical activity monitor over the triceps muscle of the right arm for 3 continuous days. Number of steps will be expressed as steps/day. The parameter measured over two days will be averaged and analyzed with the "SenseWear® 7.0 Software" program.
Measured: Second day
Physical activity (Lying down duration)
Lying down duration, one of the parameters of physical activity, will be evaluated with multisensor activity monitor (SenseWear®, Inc Pittsburgh, ABD). The patient will wear the multisensor physical activity monitor over the triceps muscle of the right arm for 3 continuous days. Lying down duration will be expressed as minutes/day. The parameter measured over two days will be averaged and analyzed with the "SenseWear® 7.0 Software" program.
Measured: Second day
Physical activity (Sleep duration)
Sleep duration, one of the parameters of physical activity, will be evaluated with multisensor activity monitor (SenseWear®, Inc Pittsburgh, ABD). The patient will wear the multisensor physical activity monitor over the triceps muscle of the right arm for 3 continuous days. Sleep duration will be expressed as minutes/day. The parameter measured over two days will be averaged and analyzed with the "SenseWear® 7.0 Software" program.
Measured: Second day
Pulmonary function (Forced expiratory volume in the first second (FEV1))
Pulmonary function will be evaluated with the spirometry based on American Thoracic Society and European Respiratory Society criteria. Forced expiratory volume in the first second (FEV1) will be measured.
Measured: First day
Pulmonary function (Forced vital capacity (FVC))
Pulmonary function will be evaluated with the spirometry based on American Thoracic Society and European Respiratory Society criteria. Forced vital capacity (FVC) will be measured.
Measured: First day
Pulmonary function (FEV1 / FVC)
Pulmonary function will be evaluated with the spirometry based on American Thoracic Society and European Respiratory Society criteria. FEV1/FVC will be measured.
Measured: First day
Pulmonary function (Peak flow rate (PEF))
Pulmonary function will be evaluated with the spirometry based on American Thoracic Society and European Respiratory Society criteria. Peak flow rate (PEF) will be measured.
Measured: First day
Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%))
Pulmonary function will be evaluated with the spirometry based on American Thoracic Society and European Respiratory Society criteria. Flow rate 25-75% of forced expiratory volume (FEF 25-75%) will be measured.
Measured: First day
Balance
Static balance will be evaluated using a balance assessment device.
Measured: Second day
Arterial Stiffness
Arterial stiffness will be assessed non-invasively with arteriography device. Carotid-femoral artery pulse wave velocity, augmented index, systolic and diastolic pressures and mean arterial pressures of aort and brachial arteries will be measured. Carotid-femoral artery pulse wave velocity will be measured with tonometer on carotid artery and augmented index will be measured with sphygmomanometer on brachial artery.
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 posted12 Jun 2024
- Study start30 Apr 2024
- Primary completion30 Aug 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Arterial HypertensionStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meral Boşnak Güçlü, Gazi University
- Investigators
- Meral BOŞNAK GÜÇLÜ, Prof. Dr., Study director, Gazi UniversityEce BAYTOK, Pt. MSc., Study chair, Gazi UniversityBetül YOLERİ, Pt. MSc., Principal investigator, Gazi UniversityFatma HAYVACI CANBEYLİ, M.D., Principal investigator, Gazi UniversitySerdar KULA, Prof. Dr., Principal investigator, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06454838
- Sponsor's protocol ID
- Gazi University 2024
- Status last verified
- Dec 2024
- First submitted
- 20 May 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Holland AE, Spruit MA, Troosters T, Puhan MA, Pepin V, Saey D, McCormack MC, Carlin BW, Sciurba FC, Pitta F, Wanger J, MacIntyre N, Kaminsky DA, Culver BH, Revill SM, Hernandes NA, Andrianopoulos V, Camillo CA, Mitchell KE, Lee AL, Hill CJ, Singh SJ. An official European Respiratory Society/American Thoracic Society technical standard: field walking tests in chronic respiratory disease. Eur Respir J. 2014 Dec;44(6):1428-46. doi: 10.1183/09031936.00150314. Epub 2014 Oct 30.
PubMed 25359355Li AM, Yin J, Au JT, So HK, Tsang T, Wong E, Fok TF, Ng PC. Standard reference for the six-minute-walk test in healthy children aged 7 to 16 years. Am J Respir Crit Care Med. 2007 Jul 15;176(2):174-80. doi: 10.1164/rccm.200607-883OC. Epub 2007 Apr 26.
PubMed 17463419Feldmann A, Schmitz R, Erlacher D. Near-infrared spectroscopy-derived muscle oxygen saturation on a 0% to 100% scale: reliability and validity of the Moxy Monitor. J Biomed Opt. 2019 Nov;24(11):1-11. doi: 10.1117/1.JBO.24.11.115001.
PubMed 31741352Crum EM, O'Connor WJ, Van Loo L, Valckx M, Stannard SR. Validity and reliability of the Moxy oxygen monitor during incremental cycling exercise. Eur J Sport Sci. 2017 Sep;17(8):1037-1043. doi: 10.1080/17461391.2017.1330899. Epub 2017 May 30.
PubMed 28557670Beenakker EA, van der Hoeven JH, Fock JM, Maurits NM. Reference values of maximum isometric muscle force obtained in 270 children aged 4-16 years by hand-held dynamometry. Neuromuscul Disord. 2001 Jul;11(5):441-6. doi: 10.1016/s0960-8966(01)00193-6.
PubMed 11404114Rosenzweig EB, Abman SH, Adatia I, Beghetti M, Bonnet D, Haworth S, Ivy DD, Berger RMF. Paediatric pulmonary arterial hypertension: updates on definition, classification, diagnostics and management. Eur Respir J. 2019 Jan 24;53(1):1801916. doi: 10.1183/13993003.01916-2018. Print 2019 Jan.
PubMed 30545978Kula S, Canbeyli F, Atasayan V, Tunaoglu FS, Oguz AD. A retrospective study on children with pulmonary arterial hypertension: A single-center experience. Anatol J Cardiol. 2018 Jul;20(1):41-47. doi: 10.14744/AnatolJCardiol.2018.78370.
PubMed 29952362Zuk M, Migdal A, Jagiellowicz-Kowalska D, Mazurkiewicz K, Sadel-Wieczorek A, Brzezinska-Rajszys G. Six-Minute Walk Test in Evaluation of Children with Pulmonary Arterial Hypertension. Pediatr Cardiol. 2017 Apr;38(4):754-761. doi: 10.1007/s00246-017-1575-z. Epub 2017 Feb 27.
PubMed 28239753Atasayan V, Canbeyli F, Tunaoglu FS, Oguz AD, Celik B, Kula S. Prognostic value of oxygen saturation and heart rate during a six-minute walk test in pediatric pulmonary hypertension. Turk J Med Sci. 2021 Aug 30;51(4):1833-1840. doi: 10.3906/sag-2004-220.
PubMed 33754651
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Capacity Muscle Oxygenation and Arterial Stiffness in Children With Pulmonary Arterial Hypertension
- ClinicalTrials.gov ID
- NCT06454838
- Acronym / sponsor ID
- Gazi University 2024
- Conditions
- Pulmonary Arterial Hypertension
- Keywords
- Upper Extremity Exercise Capacity, Muscle Oxygenation, Arterial Stiffness, Respiratory Muscle Strength
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 30 Apr 2024 (actual)
- Primary completion
- 30 Aug 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 12 Jun 2024 (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 is to evaluate pulmonary function, respiratory muscle strength, upper and lower extremity exercise capacity, muscle oxygenation, dyspnea, peripheral muscle strength, arterial stiffness, physical activity level and balance in children with pulmonary arterial hypertension and compare with age- and sex-matched healthy controls.
The second aim is to investigate the relationship between upper extremity exercise capacity, arterial stiffness, respiratory and peripheral muscle strength
Detailed description
Pulmonary arterial hypertension (PAH) is defined as higher than 25 mmHg in mean pulmonary arterial pressure at rest. Pulmonary arterial hypertension is chronic and progressive disease.
Symptoms such as dyspnea, fatigue, exercise intolerance, cyanosis and syncope are shown in children with PAH. Most common symptom is dyspnea during exertion. Dyspnea at rest could occur while the severity of disease is progressed. All these symptoms have been associated with decreased cardiac output and mismatch oxygen transport.
This study is planned as a cross-sectional study. At least 13 children with PAH and at least 13 age- and sex- matched healthy controls will be included in this study. Individuals' pulmonary function (spirometer), respiratory muscle strength (mouth pressure device), upper extremity exercise capacity (the six minute Peg Board Ring Test), lower extremity exercise capacity (six minute walk test), muscle oxygenation ('Moxy' monitor device), dyspnea (modified Borg Scale), peripheral muscle strength (hand-held dynamometer), arterial stiffness (arteriograph device), physical activity level (multi-sensor activity monitor) and static balance (balance system with computed) will evaluated in children with PAH and healthy controls. All assessments will be completed in two days.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children with pulmonary arterial hypertension | – | –Pulmonary function (spirometer), respiratory muscle strength (mouth pressure device), upper extremity exercise capacity (Six minutes PegBoard Ring Test) and lower extremity exercise capacity (Six minutes walk test), muscle oxygenation ('Moxy' monitor device), dyspnea (modified Borg Scale), peripheral muscle strength (hand-held dynamometer), arterial stiffness (arteriograph), physical activity level (multi-sensor activity monitor) and static balance (balance system with computed) will be evaluated. |
| Age- and sex- matched healthy controls | – | –Pulmonary function (spirometer), respiratory muscle strength (mouth pressure device), upper extremity exercise capacity (Six minutes PegBoard Ring Test) and lower extremity exercise capacity (Six minutes walk test), muscle oxygenation ('Moxy' monitor device), dyspnea (modified Borg Scale), peripheral muscle strength (hand-held dynamometer), arterial stiffness (arteriograph), physical activity level (multi-sensor activity monitor) and static balance (balance system with computed) will be evaluated. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- At least 13 children with PAH and 13 age- and sex- matched healthy controls will be included in the study.
Key inclusion criteria (7 listed)
- Between the ages of 6-18
- Diagnosed with pulmonary arterial hypertension
- Stability of clinical condition and receiving standard medical treatment
- Between the ages of 6-18
- Willing to participate in the study
Key exclusion criteria (6 listed)
- Having any acute infection, orthopedic, neurological, cooperation, vision or hearing problems that may prevent during the measurements
- Participated in a planned exercise program in a last three months
- Having any acute or chronic illness
- Active or ex-smoker
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
Six minutes PegBoard and Ring Test (6-PBRT) will be applied to evaluate upper extremity exercise capacity. There are a total of 20 rings and 2 wooden bars at above and 2 wooden bars at below. Patients will be asked to move the each two rings from upper bars to lower bars and than from lower bars to upper bars with hands as fast as. The total number of rings moved during the test will be recorded at the end of test.
Muscle oxygenation
Time frame: First day
Muscle oxygenation will be evaluated with the Moxy monitor (Moxy, Fortiori Design LLC, Minnesota, USA) as a non-invasive. The device will be attached with soft tape on the participants' skin surface. The device will be placed on the 1/3 lower motor point of the deltoid muscle group of the dominant arm during the the six minutes PegBoard and Ring Test and placed on the 1/3 lower motor point of the quadriceps muscle of dominant leg during the six minutes walk test. At rest and during the test, skeletal muscle oxygenation (StO2) and total hemoglobin (THb) values will be recorded.
18 secondary outcomes
Respiratory muscle strength
Time frame: First day
Peripheral muscle strength
Time frame: Second day
Dyspnea
Time frame: Second day
Lower extremity exercise capacity
Time frame: Second day
Physical activity (Total energy expenditure)
Time frame: Second day
Physical activity (Active energy expenditure)
Time frame: Second day
Physical activity (Physical activity duration)
Time frame: Second day
Physical activity (Average metabolic equivalent)
Time frame: Second day
Physical activity (Number of steps)
Time frame: Second day
Physical activity (Lying down duration)
Time frame: Second day
Physical activity (Sleep duration)
Time frame: Second day
Pulmonary function (Forced expiratory volume in the first second (FEV1))
Time frame: First day
Pulmonary function (Forced vital capacity (FVC))
Time frame: First day
Pulmonary function (FEV1 / FVC)
Time frame: First day
Pulmonary function (Peak flow rate (PEF))
Time frame: First day
Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%))
Time frame: First day
Balance
Time frame: Second day
Arterial Stiffness
Time frame: Second day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Background: PubMed 25359355Holland AE, Spruit MA, Troosters T, Puhan MA, Pepin V, Saey D, McCormack MC, Carlin BW, Sciurba FC, Pitta F, Wanger J, MacIntyre N, Kaminsky DA, Culver BH, Revill SM, Hernandes NA, Andrianopoulos V, Camillo CA, Mitchell KE, Lee AL, Hill CJ, Singh SJ. An official European Respiratory Society/American Thoracic Society technical standard: field walking tests in chronic respiratory disease. Eur Respir J. 2014 Dec;44(6):1428-46. doi: 10.1183/09031936.00150314. Epub 2014 Oct 30.
- Background: PubMed 17463419Li AM, Yin J, Au JT, So HK, Tsang T, Wong E, Fok TF, Ng PC. Standard reference for the six-minute-walk test in healthy children aged 7 to 16 years. Am J Respir Crit Care Med. 2007 Jul 15;176(2):174-80. doi: 10.1164/rccm.200607-883OC. Epub 2007 Apr 26.
- Background: PubMed 31741352Feldmann A, Schmitz R, Erlacher D. Near-infrared spectroscopy-derived muscle oxygen saturation on a 0% to 100% scale: reliability and validity of the Moxy Monitor. J Biomed Opt. 2019 Nov;24(11):1-11. doi: 10.1117/1.JBO.24.11.115001.
- Background: PubMed 28557670Crum EM, O'Connor WJ, Van Loo L, Valckx M, Stannard SR. Validity and reliability of the Moxy oxygen monitor during incremental cycling exercise. Eur J Sport Sci. 2017 Sep;17(8):1037-1043. doi: 10.1080/17461391.2017.1330899. Epub 2017 May 30.
- Background: PubMed 11404114Beenakker EA, van der Hoeven JH, Fock JM, Maurits NM. Reference values of maximum isometric muscle force obtained in 270 children aged 4-16 years by hand-held dynamometry. Neuromuscul Disord. 2001 Jul;11(5):441-6. doi: 10.1016/s0960-8966(01)00193-6.
- Background: PubMed 30545978Rosenzweig EB, Abman SH, Adatia I, Beghetti M, Bonnet D, Haworth S, Ivy DD, Berger RMF. Paediatric pulmonary arterial hypertension: updates on definition, classification, diagnostics and management. Eur Respir J. 2019 Jan 24;53(1):1801916. doi: 10.1183/13993003.01916-2018. Print 2019 Jan.
- Background: PubMed 29952362Kula S, Canbeyli F, Atasayan V, Tunaoglu FS, Oguz AD. A retrospective study on children with pulmonary arterial hypertension: A single-center experience. Anatol J Cardiol. 2018 Jul;20(1):41-47. doi: 10.14744/AnatolJCardiol.2018.78370.
- Background: PubMed 28239753Zuk M, Migdal A, Jagiellowicz-Kowalska D, Mazurkiewicz K, Sadel-Wieczorek A, Brzezinska-Rajszys G. Six-Minute Walk Test in Evaluation of Children with Pulmonary Arterial Hypertension. Pediatr Cardiol. 2017 Apr;38(4):754-761. doi: 10.1007/s00246-017-1575-z. Epub 2017 Feb 27.
- Background: PubMed 33754651Atasayan V, Canbeyli F, Tunaoglu FS, Oguz AD, Celik B, Kula S. Prognostic value of oxygen saturation and heart rate during a six-minute walk test in pediatric pulmonary hypertension. Turk J Med Sci. 2021 Aug 30;51(4):1833-1840. doi: 10.3906/sag-2004-220.
- 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.
Ece BAYTOK, Pt. MSc. contact
Meral BOŞNAK GÜÇLÜ, Prof. Dr. study director
Gazi University
Ece BAYTOK, Pt. MSc. study chair
Gazi University
Betül YOLERİ, Pt. MSc. principal investigator
Gazi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Arterial Hypertension, run by Gazi University at 1 site 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 7 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Meral BOŞNAK GÜÇLÜ, Prof. Dr. (+903122162647, meralbosnak@gazi.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Upper extremity exercise capacity (time frame: First day). The study lists 2 primary outcomes in all. 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 NCT06454838, which also lists 9 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 27 Dec 2024.