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

NCT ID: NCT05124015

Last Updated: 2025-03-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 33 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-11-10
• Study Completion Date: 2022-01-01

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.

Conditions

Pulmonary Arterial Hypertension

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Patients with pulmonary arterial hypertension

Exercise capacity using six minute walk test, respiratory muscle strength using mouth pressure device, pulmonary function using spirometry, dyspnea using Modified Borg scale physical activity using multi-sensor activity monitor.

No interventions assigned to this group

Healthy controls

Exercise capacity using six minute walk test, respiratory muscle strength using mouth pressure device, pulmonary function using spirometry, dyspnea using Modified Borg scale physical activity using multi-sensor activity monitor.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Between the ages of 6-18

2. Diagnosed with pulmonary arterial hypertension

3. Clinically stable and receiving standard medical treatment

1) To be between the ages of 6-18

Exclusion Criteria

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

1. Having any acute or chronic illness

2. Active or ex-smoker

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Gazi University

OTHER

Sponsor Role: lead

Responsible Party

Meral Boşnak Güçlü

Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ece Baytok, Pt. MSc

Role: STUDY_CHAIR

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

Gülşah Barğı, PhD. Pt.

Role: PRINCIPAL_INVESTIGATOR

Izmir Democracy University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation

Betül Yoleri, Pt. MSc

Role: PRINCIPAL_INVESTIGATOR

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

Fatma İncedere, Dr

Role: PRINCIPAL_INVESTIGATOR

Gazi University

Serdar Kula, Prof.Dr.

Role: PRINCIPAL_INVESTIGATOR

Gazi University

Fatma Sedef Tunaoğlu, Prof.Dr.

Role: PRINCIPAL_INVESTIGATOR

Gazi University

Meral Boşnak Güçlü, Prof. Dr.

Role: STUDY_DIRECTOR

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

Locations

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

Ankara, Çankaya, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 26320113 (View on PubMed)

McGoon M, Gutterman D, Steen V, Barst R, McCrory DC, Fortin TA, Loyd JE; American College of Chest Physicians. Screening, early detection, and diagnosis of pulmonary arterial hypertension: ACCP evidence-based clinical practice guidelines. Chest. 2004 Jul;126(1 Suppl):14S-34S. doi: 10.1378/chest.126.1_suppl.14S.

Reference Type: BACKGROUND

PMID: 15249493 (View on PubMed)

Douwes JM, Hegeman AK, van der Krieke MB, Roofthooft MT, Hillege HL, Berger RM. Six-minute walking distance and decrease in oxygen saturation during the six-minute walk test in pediatric pulmonary arterial hypertension. Int J Cardiol. 2016 Jan 1;202:34-9. doi: 10.1016/j.ijcard.2015.08.155. Epub 2015 Aug 28.

Reference Type: BACKGROUND

PMID: 26386916 (View on PubMed)

Cappelleri JC, Hwang LJ, Mardekian J, Mychaskiw MA. Assessment of measurement properties of peak VO(2) in children with pulmonary arterial hypertension. BMC Pulm Med. 2012 Sep 10;12:54. doi: 10.1186/1471-2466-12-54.

Reference Type: BACKGROUND

PMID: 22963001 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19118264 (View on PubMed)

Other Identifiers

Gazi University 128

Identifier Type: -

Identifier Source: org_study_id