Clinical trial NCT06454838: Exercise Capacity Muscle Oxygenation and Arterial Stiffness in Children With Pulmonary Arterial Hypertension
Official title: Exercise Capacity Muscle Oxygenation and Arterial Stiffness in Children With Pulmonary Arterial Hypertension
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pulmonary Arterial Hypertension
Keywords: Upper Extremity Exercise Capacity
Muscle Oxygenation
Arterial Stiffness
Respiratory Muscle Strength
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2024-06-12
Enrollment: 26
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Upper extremity exercise capacity
timeFrame: First day
measure: Muscle oxygenation
timeFrame: First day
Secondary outcomes:
measure: Respiratory muscle strength
timeFrame: First day
measure: Peripheral muscle strength
timeFrame: Second day
measure: Dyspnea
timeFrame: Second day
measure: Lower extremity exercise capacity
timeFrame: Second day
measure: Physical activity (Total energy expenditure)
timeFrame: Second day
measure: Physical activity (Active energy expenditure)
timeFrame: Second day
measure: Physical activity (Physical activity duration)
timeFrame: Second day
measure: Physical activity (Average metabolic equivalent)
timeFrame: Second day
measure: Physical activity (Number of steps)
timeFrame: Second day
measure: Physical activity (Lying down duration)
timeFrame: Second day
measure: Physical activity (Sleep duration)
timeFrame: Second day
measure: Pulmonary function (Forced expiratory volume in the first second (FEV1))
timeFrame: First day
measure: Pulmonary function (Forced vital capacity (FVC))
timeFrame: First day
measure: Pulmonary function (FEV1 / FVC)
timeFrame: First day
measure: Pulmonary function (Peak flow rate (PEF))
timeFrame: First day
measure: Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%))
timeFrame: First day
measure: Balance
timeFrame: Second day
measure: Arterial Stiffness
timeFrame: Second day
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation, Cardiopulmonary Rehabilitation Unit
state: Çankaya
Study officials:
affiliation: Gazi University
name: Meral BOŞNAK GÜÇLÜ, Prof. Dr.
role: STUDY_DIRECTOR
affiliation: Gazi University
name: Ece BAYTOK, Pt. MSc.
role: STUDY_CHAIR
affiliation: Gazi University
name: Betül YOLERİ, Pt. MSc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Gazi University
name: Fatma HAYVACI CANBEYLİ, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Gazi University
name: Serdar KULA, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
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