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

NCT06454838 | Recruiting

• 1 other identifier: Gazi University 2024
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Pulmonary Arterial Hypertension

Keywords

Upper Extremity Exercise Capacity; Muscle Oxygenation; Arterial Stiffness; Respiratory Muscle Strength

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (18)

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

At least 13 children with PAH and 13 age- and sex- matched healthy controls will be included in the study.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Gazi University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation, Cardiopulmonary Rehabilitation Unit

Ankara, Çankaya, 06490, Turkey (Türkiye)

RECRUITING

Related Publications (9)

• 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.

  PMID: 25359355 BACKGROUND

• 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.

  PMID: 17463419 BACKGROUND

• 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.

  PMID: 31741352 BACKGROUND

• 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.

  PMID: 28557670 BACKGROUND

• 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.

  PMID: 11404114 BACKGROUND

• 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.

  PMID: 30545978 BACKGROUND

• 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.

  PMID: 29952362 BACKGROUND

• 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.

  PMID: 28239753 BACKGROUND

• 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.

  PMID: 33754651 BACKGROUND

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Meral BOŞNAK GÜÇLÜ, Prof. Dr.

  Gazi University

  STUDY DIRECTOR

• Ece BAYTOK, Pt. MSc.

  Gazi University

  STUDY CHAIR

• Betül YOLERİ, Pt. MSc.

  Gazi University

  PRINCIPAL INVESTIGATOR

• Fatma HAYVACI CANBEYLİ, M.D.

  Gazi University

  PRINCIPAL INVESTIGATOR

• Serdar KULA, Prof. Dr.

  Gazi University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Meral BOŞNAK GÜÇLÜ, Prof. Dr.

CONTACT

+903122162647; meralbosnak@gazi.edu.tr

Ece BAYTOK, Pt. MSc.

CONTACT

ecebaytok@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: May 20, 2024
• First Posted: June 12, 2024
• Study Start: April 30, 2024
• Primary Completion: August 30, 2025
• Study Completion: December 30, 2025
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)