NCT06454838|Recruiting
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Sponsor study identifier
observational
26
1 country
1
Study Start
April 30, 2024
Actual (reported)Primary Completion
August 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 30, 2024
Actual (reported)May 20, 2024
Actual (reported)June 12, 2024
Actual (reported)August 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
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.
First day
Respiratory muscle strength
First day
Peripheral muscle strength
Second day
Dyspnea
Second day
Lower extremity exercise capacity
Second day
Physical activity (Total energy expenditure)
Second day
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.
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.
At least 13 children with PAH and 13 age- and sex- matched healthy controls will be included in the study.
Gazi University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation, Cardiopulmonary Rehabilitation Unit
Ankara, Çankaya, 06490, Turkey (Türkiye)
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.
Li 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.
Meral BOŞNAK GÜÇLÜ, Prof. Dr.
Gazi University
Ece BAYTOK, Pt. MSc.
Gazi University
Betül YOLERİ, Pt. MSc.
Gazi University
Fatma HAYVACI CANBEYLİ, M.D.
Gazi University
First Submitted
May 20, 2024
First Posted
June 12, 2024
Study Start
April 30, 2024
Actual (reported)Primary Completion
August 30, 2025
Estimated (date passed)A Study of HS135 for the Treatment of Pulmonary Arterial Hypertension in Adults
Contact the study team to confirm eligibility.
Feldmann 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.
Crum 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.
Beenakker 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.
Rosenzweig 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.
Kula 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.
Zuk 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.
Atasayan 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.
Serdar KULA, Prof. Dr.
Gazi University
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
December 27, 2024
Record last verified: 2024-12
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