Clinical trial NCT05124015: Exercise Capacity Respiratory Muscle Strength Dyspnea and Physical Activity in Pediatric Pulmonary Arterial Hypertension
Official title: Exercise Capacity Respiratory Muscle Strength Pulmonary Function Dyspnea and Physical Activity in Pediatric Pulmonary Arterial Hypertension
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Arterial Hypertension
Keywords: muscle strength
exercise
exercise test
physical activity
pulmonary arterial hypertension
Respiratory Function Tests
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2021-11-17
Enrollment: 33
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: 13 patients with PAH and 15 healthy individuals were included in the study.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

The inclusion criteria for patients with PAH are as follows:

1. Between the ages of 6-18
2. Diagnosed with pulmonary arterial hypertension
3. Clinically stable and receiving standard medical treatment

The inclusion criteria for healthy children are as follows:

1) To be between the ages of 6-18

Exclusion Criteria:

The exclusion criteria for patients with PAH are as follows:

1) 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:

1. Having any acute or chronic illness
2. Active or ex-smoker

Primary outcomes:
measure: Exercise capacity
timeFrame: First Day
Secondary outcomes:
measure: Respiratory muscle strength
timeFrame: First Day
measure: Pulmonary function (Forced vital capacity (FVC))
timeFrame: First Day
measure: Pulmonary function (Forced expiratory volume in the first second (FEV1))
timeFrame: First day
measure: Pulmonary function (FEV1 / FVC)
timeFrame: First day
measure: Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%))
timeFrame: First Day
measure: Pulmonary function (Peak flow rate (PEF))
timeFrame: First Day
measure: Dyspnea
timeFrame: First day
measure: Physical activity (Total energy expenditure)
timeFrame: Second Day
measure: Physical activity (Active energy expenditure (joule / day))
timeFrame: Second Day
measure: Physical activity (Physical activity time (min / day))
timeFrame: Second day
measure: Physical activity (Average metabolic equivalent (MET / day))
timeFrame: Second day
measure: Physical activity (Number of steps (steps / day))
timeFrame: Second day
measure: Physical activity (Time spent lying down (min / day) days))
timeFrame: Second day
measure: Physical activity (Sleep time (min / day))
timeFrame: Second day
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University Faculty of Health Sciences Department of Physical Therapy and Rehabilitation
state: Çankaya
Study officials:
affiliation: Gazi University, Faculty of Health Sciences, Department of Cardiopulmonary Physical Therapy and Rehabilitation
name: Ece Baytok, Pt. MSc
role: STUDY_CHAIR
affiliation: Izmir Democracy University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
name: Gülşah Barğı, PhD. Pt.
role: PRINCIPAL_INVESTIGATOR
affiliation: Gazi University, Faculty of Health Sciences, Department of Cardiopulmonary Physical Therapy and Rehabilitation
name: Betül Yoleri, Pt. MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Gazi University
name: Fatma İncedere, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Gazi University
name: Serdar Kula, Prof.Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Gazi University
name: Fatma Sedef Tunaoğlu, Prof.Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Gazi University, Faculty of Health Sciences, Department of Cardiopulmonary Physical Therapy and Rehabilitation
name: Meral Boşnak Güçlü, Prof. Dr.
role: STUDY_DIRECTOR
References:
citation: Galie N, Humbert M, Vachiery JL, Gibbs S, Lang I, Torbicki A, Simonneau G, Peacock A, Vonk Noordegraaf A, Beghetti M, Ghofrani A, Gomez Sanchez MA, Hansmann G, Klepetko W, Lancellotti P, Matucci M, McDonagh T, Pierard LA, Trindade PT, Zompatori M, Hoeper M; ESC Scientific Document Group. 2015 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension: The Joint Task Force for the Diagnosis and Treatment of Pulmonary Hypertension of the European Society of Cardiology (ESC) and the European Respiratory Society (ERS): Endorsed by: Association for European Paediatric and Congenital Cardiology (AEPC), International Society for Heart and Lung Transplantation (ISHLT). Eur Heart J. 2016 Jan 1;37(1):67-119. doi: 10.1093/eurheartj/ehv317. Epub 2015 Aug 29. No abstract available.
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citation: Smith G, Reyes JT, Russell JL, Humpl T. Safety of maximal cardiopulmonary exercise testing in pediatric patients with pulmonary hypertension. Chest. 2009 May;135(5):1209-1214. doi: 10.1378/chest.08-1658. Epub 2008 Dec 31.