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

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 st...

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Autores principales: Morris, Norman R., Louis, Menaka, Strugnell, Wendy, Harris, Julie, Lin, Aaron, Feenstra, John, Seale, Helen
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5831614/
https://www.ncbi.nlm.nih.gov/pubmed/29490637
http://dx.doi.org/10.1186/s12890-018-0586-8
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author Morris, Norman R.
Louis, Menaka
Strugnell, Wendy
Harris, Julie
Lin, Aaron
Feenstra, John
Seale, Helen
author_facet Morris, Norman R.
Louis, Menaka
Strugnell, Wendy
Harris, Julie
Lin, Aaron
Feenstra, John
Seale, Helen
author_sort Morris, Norman R.
collection PubMed
description 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.
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spelling pubmed-58316142018-03-05 Study protocol for a randomised controlled trial of exercise training in pulmonary hypertension (ExTra_PH) Morris, Norman R. Louis, Menaka Strugnell, Wendy Harris, Julie Lin, Aaron Feenstra, John Seale, Helen BMC Pulm Med Study Protocol 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. BioMed Central 2018-03-01 /pmc/articles/PMC5831614/ /pubmed/29490637 http://dx.doi.org/10.1186/s12890-018-0586-8 Text en © The Author(s). 2018 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Study Protocol
Morris, Norman R.
Louis, Menaka
Strugnell, Wendy
Harris, Julie
Lin, Aaron
Feenstra, John
Seale, Helen
Study protocol for a randomised controlled trial of exercise training in pulmonary hypertension (ExTra_PH)
title Study protocol for a randomised controlled trial of exercise training in pulmonary hypertension (ExTra_PH)
title_full Study protocol for a randomised controlled trial of exercise training in pulmonary hypertension (ExTra_PH)
title_fullStr Study protocol for a randomised controlled trial of exercise training in pulmonary hypertension (ExTra_PH)
title_full_unstemmed Study protocol for a randomised controlled trial of exercise training in pulmonary hypertension (ExTra_PH)
title_short Study protocol for a randomised controlled trial of exercise training in pulmonary hypertension (ExTra_PH)
title_sort study protocol for a randomised controlled trial of exercise training in pulmonary hypertension (extra_ph)
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5831614/
https://www.ncbi.nlm.nih.gov/pubmed/29490637
http://dx.doi.org/10.1186/s12890-018-0586-8
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