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Completed

NCT Number: NCT05124015

Exercise Capacity Respiratory Muscle Strength Dyspnea and Physical Activity in Pediatric Pulmonary Arterial Hypertension

The primary aim of this study was to evaluate exercise capacity, respiratory muscle strength, pulmonary function, dyspnea and physical activity levels in pediatric PAH patients and compare them with healthy controls.

The secondary aim of the study was; To investigate the relationship of dyspnea with exercise capacity, respiratory muscle strength, respiratory functions, physical activity and blood count parameters in pediatric PAH patients.

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Key information

Conditions

Pulmonary Arterial Hypertension Behavior Hypertension, Pulmonary Lung Diseases Motor Activity Respiratory Tract Diseases

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Gazi University Faculty of Health Sciences Department of Physical Therapy and Rehabilitation

Ankara, Çankaya, 06580, Turkey (Türkiye)

About this study

Pulmonary arterial hypertension (PAH) is a mean pulmonary artery pressure of 25 mmHg or more at rest. Since the diagnosis of PAH can be made mostly in the late phase of the disease, severe functional and hemodynamic problems are prevalent in patients. In addition, patients commonly present with dyspnea, fatigue, weakness, general exercise intolerance, chest pain, syncope, and abdominal distension. These signs and symptoms are due to reduced oxygen consumption and decreased cardiac output. Activity dyspnea is evident in patients in the early stages of the disease. There is limited number of studies in pediatric PAH patients investigating exercise intolerance. While the cardiopulmonary exercise test can be safely performed in pediatric PAH patients, the six-minute walk test is both an independent predictor of prognosis and reflects the severity of the disease in these patients. However, there are no studies in the literature investigating and comparing exercise capacity, respiratory muscle strength, respiratory functions, dyspnea, and physical activity levels in pediatric PAH patients compared to age- and sex-matched healthy children. For this reason, in this study, the level of physical impairments of children with pediatric PAH was investigated for the first time compared to healthy children. In addition, there has been no study in the literature investigated the relationship between dyspnea, which can be seen significantly from the early stages of the disease in pediatric PAH patients, with exercise capacity, respiratory function, respiratory muscle strength, physical activity levels and blood count parameters.

It is a cross-sectional study. At least 15 PAH patients and 15 age-and sex-matched healthy controls were aimed to include in the study. Individuals' exercise capacity using six minute walk test, respiratory muscle strength using a mouth pressure device, pulmonary function using spirometry, dyspnea using Modified Borg scale, physical activity using multi-sensory activity monitor were evaluated. The assessments were completed in two days.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

The inclusion criteria for patients with PAH are as follows:

  • Between the ages of 6-18
  • Diagnosed with pulmonary arterial hypertension
  • Clinically stable and receiving standard medical treatment

The inclusion criteria for healthy children are as follows:

  • To be between the ages of 6-18

Exclusion criteria

The exclusion criteria for patients with PAH are as follows:

  • Having any acute infection, orthopedic, neurological, cooperation, vision or hearing problems that may interfere during the measurements

The exclusion criteria for healthy children are as follows:

  • Having any acute or chronic illness
  • Active or ex-smoker

Treatment and study plan

Primary outcomes

  1. Exercise capacity

    Time frame: First Day

    Functional exercise capacity was evaluated using the 6- Minute Walk Test. 6- Minute Walk Test will be applied according to the American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria.

Secondary outcomes

  1. Respiratory muscle strength

    Time frame: First Day

    Maximal inspiratory (MIP) and maximal expiratory (MEP) pressures expressing respiratory muscle strength were measured using a portable mouth pressure measuring device according to ATS and ERS criteria.

  2. Pulmonary function (Forced vital capacity (FVC))

    Time frame: First Day

    Pulmonary function was evaluated using the spirometry. Dynamic lung volume measurements were conducted according to ATS and ERS criteria. With the device, forced vital capacity (FVC)was evaluated.

  3. Pulmonary function (Forced expiratory volume in the first second (FEV1))

    Time frame: First day

    Pulmonary function was evaluated with the spirometry. Dynamic lung volume measurements were conducted according to ATS and ERS criteria. With the device, forced expiratory volume in the first second (FEV1) was evaluated.

  4. Pulmonary function (FEV1 / FVC)

    Time frame: First day

    Pulmonary function was evaluated with the spirometry. Dynamic lung volume measurements were conducted according to ATS and ERS criteria. With the device, FEV1 / FVC was evaluated.

  5. Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%))

    Time frame: First Day

    Pulmonary function was evaluated using the spirometry. Dynamic lung volume measurements were conducted according to ATS and ERS criteria. With the device, flow rate 25-75% of forced expiratory volume (FEF 25-75%)was evaluated.

  6. Pulmonary function (Peak flow rate (PEF))

    Time frame: First Day

    Pulmonary function was evaluated using the spirometry. Dynamic lung volume measurements were conducted according to ATS and ERS criteria. With the device, peak flow rate (PEF) was evaluated.

  7. Dyspnea

    Time frame: First day

    Subjectively, dyspnea at rest and during activity, orthopnea, paroxysmal nocturnal dyspnea, activities that increase dyspnea, and severity of dyspnea (using the Modified Borg scale) was evaluated.

  8. Physical activity (Total energy expenditure)

    Time frame: Second Day

    Physical activity was evaluated with the Multi sensor activity monitor (SenseWear®, Inc Pittsburgh, ABD). The patient wore the multisensor physical activity monitor over the triceps muscle of the non-dominant arm for 3 continuous days. The patient was informed about removing the device while taking a bath. Total energy expenditure (joule / day) will be measured with the multi-sensor physical activity monitor. The parameters measured over two days were averaged and analyzed with the "SenseWear® 7.0 Software" program.

  9. Physical activity (Active energy expenditure (joule / day))

    Time frame: Second Day

    Physical activity was evaluated with the Multi sensor activity monitor (SenseWear®, Inc Pittsburgh, ABD). The patient wore the multisensor physical activity monitor over the triceps muscle of the non-dominant arm for 3 continuous days. The patient was informed about removing the device while taking a bath. Total energy expenditure (joule / day) will be measured with the multi-sensor physical activity monitor. The parameters measured over two days were averaged and analyzed with the "SenseWear® 7.0 Software" program.

  10. Physical activity (Physical activity time (min / day))

    Time frame: Second day

    Physical activity was evaluated with the Multi sensor activity monitor (SenseWear®, Inc Pittsburgh, ABD). The patient wore the multisensor physical activity monitor over the triceps muscle of the non-dominant arm for 3 continuous days. The patient was informed about removing the device while taking a bath. Total energy expenditure (joule / day) will be measured with the multi-sensor physical activity monitor. The parameters measured over two days were averaged and analyzed with the "SenseWear® 7.0 Software" program.

  11. Physical activity (Average metabolic equivalent (MET / day))

    Time frame: Second day

    Physical activity was evaluated with the Multi sensor activity monitor (SenseWear®, Inc Pittsburgh, ABD). The patient wore the multisensor physical activity monitor over the triceps muscle of the non-dominant arm for 3 continuous days. The patient was informed about removing the device while taking a bath. Total energy expenditure (joule / day) will be measured with the multi-sensor physical activity monitor. The parameters measured over two days were averaged and analyzed with the "SenseWear® 7.0 Software" program.

  12. Physical activity (Number of steps (steps / day))

    Time frame: Second day

    Physical activity was evaluated with the Multi sensor activity monitor (SenseWear®, Inc Pittsburgh, ABD). The patient wore the multisensor physical activity monitor over the triceps muscle of the non-dominant arm for 3 continuous days. The patient was informed about removing the device while taking a bath. Total energy expenditure (joule / day) will be measured with the multi-sensor physical activity monitor. The parameters measured over two days were averaged and analyzed with the "SenseWear® 7.0 Software" program.

  13. Physical activity (Time spent lying down (min / day) days))

    Time frame: Second day

    Physical activity was evaluated with the Multi sensor activity monitor (SenseWear®, Inc Pittsburgh, ABD). The patient wore the multisensor physical activity monitor over the triceps muscle of the non-dominant arm for 3 continuous days. The patient was informed about removing the device while taking a bath. Total energy expenditure (joule / day) will be measured with the multi-sensor physical activity monitor. The parameters measured over two days were averaged and analyzed with the "SenseWear® 7.0 Software" program.

  14. Physical activity (Sleep time (min / day))

    Time frame: Second day

    Physical activity was evaluated with the Multi sensor activity monitor (SenseWear®, Inc Pittsburgh, ABD). The patient wore the multisensor physical activity monitor over the triceps muscle of the non-dominant arm for 3 continuous days. The patient was informed about removing the device while taking a bath. Total energy expenditure (joule / day) will be measured with the multi-sensor physical activity monitor. The parameters measured over two days were averaged and analyzed with the "SenseWear® 7.0 Software" program.

Sponsors and collaborators

Lead sponsor

Gazi University

Other

Registry information

Official study title

Exercise Capacity Respiratory Muscle Strength Pulmonary Function Dyspnea and Physical Activity in Pediatric Pulmonary Arterial Hypertension

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Nov 17, 2021
Registry last updated
Mar 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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