Skip to main content
Clinical Trials/NCT05124015
NCT05124015
Completed
N/A

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

Gazi University1 site in 1 country33 target enrollmentNovember 10, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Pulmonary Arterial Hypertension
Sponsor
Gazi University
Enrollment
33
Locations
1
Primary Endpoint
Exercise capacity
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 10, 2019
End Date
January 1, 2022
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Meral Boşnak Güçlü

Prof. Dr.

Gazi University

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

  • Pulmonary function (FEV1 / FVC)(First day)
  • Pulmonary function (Peak flow rate (PEF))(First Day)
  • Dyspnea(First day)
  • Physical activity (Time spent lying down (min / day) days))(Second day)
  • Pulmonary function (Forced expiratory volume in the first second (FEV1))(First day)
  • Physical activity (Average metabolic equivalent (MET / day))(Second day)
  • Respiratory muscle strength(First Day)
  • Pulmonary function (Forced vital capacity (FVC))(First Day)
  • Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%))(First Day)
  • Physical activity (Physical activity time (min / day))(Second day)
  • Physical activity (Number of steps (steps / day))(Second day)
  • Physical activity (Total energy expenditure)(Second Day)
  • Physical activity (Active energy expenditure (joule / day))(Second Day)
  • Physical activity (Sleep time (min / day))(Second day)

Study Sites (1)

Loading locations...

Similar Trials

Exercise Capacity Respiratory Muscle... | Clinical Trial