Exercise Capacity Muscle Oxygenation and Arterial Stiffness in Children With Pulmonary Arterial Hypertension

Pulmonary Arterial Hypertension Clinical Trial

Official title:

Exercise Capacity Muscle Oxygenation and Arterial Stiffness in Children With Pulmonary Arterial Hypertension

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06454838
• Other study ID #: Gazi University 2024
• Status: Recruiting
• Start date: April 30, 2024
• Est. completion date: December 30, 2024

Study information

• Verified date: June 2024
• Source: Gazi University
• Contact: Meral BOSNAK GÜÇLÜ, Prof. Dr.
• Phone: +903122162647
• Email: meralbosnak[@]gazi.edu.tr
• Is FDA regulated: No
• Study type: Observational

Clinical 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 sex-matched healthy controls.

The second aim is to investigate the relationship between upper extremity exercise capacity, arterial stiffness, respiratory and peripheral muscle strength

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 26
• Est. completion date: December 30, 2024
• Est. primary completion date: October 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Familial Primary Pulmonary Hypertension
• Hypertension
• Pulmonary Arterial Hypertension

Locations

Country	Name	City	State
Turkey	Gazi University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation, Cardiopulmonary Rehabilitation Unit	Ankara	Çankaya

Sponsors (1)

Lead Sponsor	Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	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.	First day
Secondary	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.	Second day
Secondary	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'.	Second day
Secondary	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.	Second day
Secondary	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.	Second day
Secondary	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.	Second day
Secondary	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.	Second day
Secondary	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.	Second day
Secondary	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.	Second day
Secondary	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.	Second day
Secondary	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.	Second day
Secondary	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.	First day
Secondary	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.	First day
Secondary	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.	First day
Secondary	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.	First day
Secondary	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.	First day
Secondary	Balance	Static balance will be evaluated using a balance assessment device.	Second day
Secondary	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.	Second day