Article Text

Protocol
Exercise training modalities for heart transplant recipients: a systematic review and network meta-analysis protocol
  1. Juliana Beust de Lima1,2,3,
  2. Douglas dos Santos Soares1,3,
  3. Filipe Ferrari1,2,3,
  4. Nelson Carvas Junior4,
  5. Gabriel Carvalho2,
  6. Santiago Alonso Tobar Leitão1,3,
  7. Lívia Adams Goldraich3,5,
  8. Nadine Clausell1,3,5,6,
  9. Ricardo Stein1,2,3,6
  1. 1 Graduate Program in Cardiology and Cardiovascular Sciences, Universidade Federal do Rio Grande do Sul, Hospital das Clínicas de Porto Alegre, Porto Alegre, RS, Brazil
  2. 2 Exercise Cardiology Research Group, Universidade Federal do Rio Grande do Sul, Hospital de Clínicas de Porto Alegre, Porto Alegre, RS, Brazil
  3. 3 Interdisciplinary Research Group in Translational Cardiology, Clinical Research Center, Hospital das Clínicas de Porto Alegre, Porto Alegre, RS, Brazil
  4. 4 Department of Evidence-Based Health, Brazilian Cochrane Center, Universidade Federal de São Paulo, São Paulo, SP, Brazil
  5. 5 Heart Failure and Cardiac Transplant Unit, Cardiology Division, Hospital das Clínicas de Porto Alegre, Porto Alegre, Rio Grande do Sul, Brazil
  6. 6 Associate Professor, School of Medicine, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil
  1. Correspondence to MSc Juliana Beust de Lima; julianabeustdelima{at}gmail.com

Abstract

Introduction Heart transplantation is the gold standard treatment for selected patients with end-stage heart failure. Although this procedure can improve quality and prolong life expectancy, several of these patients persist with decreased exercise tolerance. Evidence suggests that exercise training can bring multifactorial benefits to heart transplant (HTx) recipients. However, it is unclear that exercise modality should be preferred. Therefore, the aim of this systematic review and network meta-analysis is to compare the efficacy and safety of different training modalities in HTx recipients.

Methods and analysis We will perform a comprehensive literature search in PubMed/MEDLINE, Embase, The Cochrane Library, CINAHL, Scopus, SportDISCUS, Web of Science Core Collection and PEDro from inception until November 2020. Two registries (ClinicalTrials.gov and REBEC) will also be searched for potential results in unpublished studies. There will be no restriction on language, date of publication, publication status or sample size. We will include randomised controlled trials enrolling adult HTx recipients with the presence of at least one exercise training group, which might be compared with another training modality and/or a non-exercise control group for a minimum of 4 weeks of intervention. The primary outcomes will be peak oxygen consumption and occurrence of adverse events. As secondary outcomes, the interaction between pulmonary ventilation, pulmonary perfusion and cardiac output, oxygen uptake efficiency slope, heart rate response, oxygen pulse, peak blood pressure and peak subjective perception of effort. In addition, we will evaluate the 6 min walking distance, health-related quality of life, endothelial function, muscle strength, body fat percentage and lean mass. Risk of bias will be assessed using the Cochrane RoB V.2.0 tool, and we plan to use the Confidence in Network Meta-Analysis tool to assess confidence in the results. All materials (raw data, processed data, statistical code and outputs) will be shared in a public repository.

Ethics and dissemination Given the nature of this study, no ethical approval will be required. We believe that the findings of this study may show which is the most efficacious and safe physical training modality for HTx recipients. The completed systematic review and network meta-analysis will be submitted to a peer-reviewed journal.

PROSPERO registration number CRD42020191192.

  • heart transplantation
  • exercise training
  • cardiorespiratory fitness
  • heart rate
  • health-related quality of life
  • safety
http://creativecommons.org/licenses/by-nc/4.0/

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, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

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Supplementary materials

Footnotes

  • Twitter @beust_lima

  • Contributors Conception of the study: JBdL, DdSS, FF, SATL, RS. Major drafters of the protocol: JBdL, DdSS, FF, NCJ, RS. Minor drafters of the protocol: SATL, GC provided feedback to the protocol: LAG, NC, RS. Data extraction and synthesis: FF, NCJ, JBdL.

  • Funding This protocol was partially supported by the Hospital de Clínicas de Porto Alegre Research Incentive Fund (FIPE-HCPA), Porto Alegre, Brazil—project number 2018-0292. JBdL and GC are granted by the Conselho Nacional de Pesquisa e Desenvolvimento (CNPq). DdSS and FF are granted by the Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES). This study is conducted by an academic institution and a research group that has no relationship with the pharmaceutical industry.

  • Competing interests None declared.

  • Patient consent for publication Not required.

  • Author note Statement: The protocol of this network meta-analysis was guided by the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) 2015 statement and the PRISMA-P 2015 Explanation and Elaboration Document. Amendments: This is the first version of the protocol. Any amendments to the protocol will be updated and published on the PROSPERO database (CRD42020191192).

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

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