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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06454838
Enrollment
26
Registered
2024-06-12
Start date
2024-04-30
Completion date
2025-12-30
Last updated
2024-12-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Arterial Hypertension

Keywords

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

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

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.

Interventions

None listed

Sponsors

Gazi University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Upper extremity exercise capacityFirst daySix 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 oxygenationFirst dayMuscle 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.

Secondary

MeasureTime frameDescription
DyspneaSecond dayPerception 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'.
Lower extremity exercise capacitySecond daySix 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.
Physical activity (Total energy expenditure)Second dayTotal 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.
Physical activity (Active energy expenditure)Second dayActive 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.
Physical activity (Physical activity duration)Second dayPhysical 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.
Physical activity (Average metabolic equivalent)Second dayAverage 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.
Physical activity (Number of steps)Second dayNumber 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.
Physical activity (Lying down duration)Second dayLying 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.
Respiratory muscle strengthFirst dayMaximal 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.
Pulmonary function (Forced expiratory volume in the first second (FEV1))First dayPulmonary 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.
Pulmonary function (Forced vital capacity (FVC))First dayPulmonary function will be evaluated with the spirometry based on American Thoracic Society and European Respiratory Society criteria. Forced vital capacity (FVC) will be measured.
Pulmonary function (FEV1 / FVC)First dayPulmonary function will be evaluated with the spirometry based on American Thoracic Society and European Respiratory Society criteria. FEV1/FVC will be measured.
Pulmonary function (Peak flow rate (PEF))First dayPulmonary function will be evaluated with the spirometry based on American Thoracic Society and European Respiratory Society criteria. Peak flow rate (PEF) will be measured.
Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%))First dayPulmonary 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.
BalanceSecond dayStatic balance will be evaluated using a balance assessment device.
Arterial StiffnessSecond dayArterial 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.
Physical activity (Sleep duration)Second daySleep 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.
Peripheral muscle strengthSecond dayIsometric 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.

Countries

Turkey (Türkiye)

Contacts

Primary ContactMeral BOŞNAK GÜÇLÜ, Prof. Dr.
meralbosnak@gazi.edu.tr+903122162647
Backup ContactEce BAYTOK, Pt. MSc.
ecebaytok@gmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026