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  • Randomised controlled trial examining the effect of an outpatient exercise training programme on haemodynamics and cardiac MR parameters of right ventricular function in patients with pulmonary arterial hypertension: the ExPAH study protocol

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Cardiovascular medicine
Protocol
Randomised controlled trial examining the effect of an outpatient exercise training programme on haemodynamics and cardiac MR parameters of right ventricular function in patients with pulmonary arterial hypertension: the ExPAH study protocol
  1. Karen S W Chia1,2,
  2. Steven G Faux3,4,5,
  3. Peter K K Wong1,2,6,
  4. Cameron Holloway4,5,
  5. Hassan Assareh1,7,
  6. Craig S McLachlan1,
  7. Eugene Kotlyar4,5
  1. 1University of New South Wales Rural Clinical School, Coffs Harbour, New South Wales, Australia
  2. 2Coffs Harbour Health Campus, Coffs Harbour, New South Wales, Australia
  3. 3Sacred Heart Rehabilitation, St Vincent's Health, Coffs Harbour, New South Wales, Australia
  4. 4University of New South Wales, Coffs Harbour, New South Wales, Australia
  5. 5St Vincent's Hospital Sydney, Coffs Harbour, New South Wales, Australia
  6. 6Mid-North Coast Arthritis Clinic, Coffs Harbour, New South Wales, Australia
  7. 7Epidemiology and Health Analytics Department, Western Sydney Local Health District, Coffs Harbour, New South Wales, Australia
  1. Correspondence to Dr Karen SW Chia; Karen.chia{at}me.com

Abstract

Introduction Pulmonary hypertension (PH) is a potentially life-threatening condition characterised by elevated pulmonary artery pressure. Early stage PH patients are often asymptomatic. Disease progression is associated with impairment of right ventricular function and progressive dyspnoea. Current guidelines recommend exercise training (grade IIa, level B). However, many questions remain regarding the mechanisms of improvement, intensity of supervision and optimal frequency, duration and intensity of exercise. This study will assess the effect of an outpatient rehabilitation programme on haemodynamics and cardiac right ventricular function in patients with pulmonary arterial hypertension (PAH), a subgroup of PH.

Methods and analysis This randomised controlled trial involves both a major urban tertiary and smaller regional hospital in New South Wales, Australia. The intervention will compare an outpatient rehabilitation programme with a control group (home exercise programme). Participants will be stable on oral PAH-specific therapy. The primary outcome measure will be right ventricular ejection fraction measured by cardiac MRI. Secondary outcomes will include haemodynamics measured by right heart catheterisation, endurance, functional capacity, health-related quality of life questionnaires and biomarkers of cardiac function and inflammation.

Ethics approval and dissemination Ethical approval has been granted by St Vincent's Hospital, Sydney (HREC/14/SVH/341). Results of this study will be disseminated through presentation at scientific conferences and in scientific journals.

Trial registration number ACTRN12615001041549; pre-results.

  • Pulmonary hypertension
  • outpatient exercise training
  • cardiac magnetic resonance imaging
  • haemodynamics

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/bmjopen-2016-014037

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    Footnotes

    • Contributors KSWC conceived the study, coordinated its design and drafted the manuscript. SGF and EK had significant input into the study protocol. PKKW, CSM, SGF and EK read and were involved in critical appraisal and revision of the manuscript. CH provided MRI expertise. HA provided statistical expertise. All authors approved the final manuscript prior to submission.

    • Funding KSWC has received grants from the Mid-North Coast Local Health District and the Royal Australasian College of Physicians for this study. KSWC and EK have received an unrestricted educational grant from Actelion. Actelion have reviewed the manuscript. However, final content and design is exclusively retained by the authors.

    • Competing interests None declared.

    • Ethics approval St Vincent's Hospital Research and Ethics Committee.

    • Provenance and peer review Not commissioned; externally peer reviewed.