Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2018 Mar 1;18(1):40.
doi: 10.1186/s12890-018-0586-8.

Study protocol for a randomised controlled trial of exercise training in pulmonary hypertension (ExTra_PH)

Norman R Morris  1   2   3   4 , Menaka Louis  5   6 , Wendy Strugnell  7 , Julie Harris  5   8 , Aaron Lin  5   6   7 , John Feenstra  8 , Helen Seale  8
Affiliations

Study protocol for a randomised controlled trial of exercise training in pulmonary hypertension (ExTra_PH)

Norman R Morris et al. BMC Pulm Med. .

Abstract

Background: Exercise training is an integral component of evidence-based management programs for many chronic cardiac and respiratory conditions. Despite this, there are limited high-quality studies available on the significance of exercise training in pulmonary hypertension (PH). The aim of this study is to evaluate the short and long-term effectiveness of exercise training in PH patients in terms of exercise capacity, quality of life, cardiac function and disease progression.

Methods: This randomized control trial will aim to recruit 50 medically stable PH patients categorised as New York Heart Association functional classification II-III. Participants will be randomly allocated to either the supervised exercise training group or usual care group for the 8-week study period. Exercise training will be conducted in an outpatient setting. Measurements at baseline and following the 8-week study period include exercise capacity (6 min walk distance and cardiopulmonary exercise test), cardiac function (exercise cardiac magnetic resonance imaging [CMRI] and echocardiography), health-related quality of life (Cambridge Pulmonary Hypertension Outcome Review), adverse responses to exercise training and time to clinical worsening. In addition, participants will be followed up for a minimum of 2 year period from commencement of the study so as to monitor long-term clinical outcomes i.e. time to clinical worsening.

Discussion: This study will determine whether an 8-week outpatient based supervised exercise training program is safe and beneficial for medically stable PH patients in the short and long term. This will be the first study to examine the impact of exercise training on right heart function using exercise CMRI. Results from the study will contribute new knowledge in relation to the impact of exercise training on cardiac function, long-term prognosis and inform clinical practice guidelines for this patient population. Moreover, the study will add to our understanding regarding the efficacy of exercise training in individuals with PH in an outpatient setting.

Trial registration: Australia and New Zealand Clinical Trials Registry: ACTRN12616001467426 . Registered 21st October, 2016.

Keywords: Exercise cardiac magnetic resonance imaging; Exercise training; Pulmonary hypertension; Randomised controlled trial; Right heart function.

PubMed Disclaimer

Conflict of interest statement

Ethics approval and consent to participate

The study has been approved by the Metro North Hospital and Health Service - The Prince Charles Hospital Human Research Ethics Committee (HREC/15/QPCH/238). All participants will provide informed, written consent prior to participation in the study.

Consent for publication

All data will be presented as a mean or median. No individual data will be included in the manuscript.

Competing interests

This study is supported by is supported by a Physiotherapy Research Fellowship from the Health Innovation, Investment and Research Office, Queensland Health.

Professor Norman Morris is supported by the Allied Health Research Collaborative Grant.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Study flow chart
See this image and copyright information in PMC

References

    1. Hoeper MM, Bogaard HJ, Condliffe R, Frantz R, Khanna D, Kurzyna M, Langleben D, Manes A, Satoh T, Torres F, et al. Definitions and diagnosis of pulmonary hypertension. J Am Coll Cardiol. 2013;62(25 Suppl):D42–D50. doi: 10.1016/j.jacc.2013.10.032. - DOI - PubMed
    1. Swiston JR, Johnson SR, Granton JT. Factors that prognosticate mortality in idiopathic pulmonary arterial hypertension: a systematic review of the literature. Respir Med. 2010;104(11):1588–1607. doi: 10.1016/j.rmed.2010.08.003. - DOI - PubMed
    1. Tonelli AR, Arelli V, Minai OA, Newman J, Bair N, Heresi GA, Dweik RA. Causes and circumstances of death in pulmonary arterial hypertension. Am J Respir Crit Care Med. 2013;188(3):365–369. doi: 10.1164/rccm.201209-1640OC. - DOI - PMC - PubMed
    1. Spruit MA, Singh SJ, Garvey C, ZuWallack R, Nici L, Rochester C, Hill K, Holland AE, Lareau SC, Man WD, et al. An official American Thoracic Society/European Respiratory Society statement: key concepts and advances in pulmonary rehabilitation. Am J Respir Crit Care Med. 2013;188(8):e13–e64. doi: 10.1164/rccm.201309-1634ST. - DOI - PubMed
    1. Galie N, Corris PA, Frost A, Girgis RE, Granton J, Jing ZC, Klepetko W, MD MG, VV ML, Preston IR, et al. Updated treatment algorithm of pulmonary arterial hypertension. J Am Coll Cardiol. 2013;62(25 Suppl):D60–D72. doi: 10.1016/j.jacc.2013.10.031. - DOI - PubMed

Publication types