Article Text

Protocol
Effects of a power strength training using elastic resistance exercises on the motor and non-motor symptoms in patients with Parkinson’s disease H&Y 1–3: study protocol for a randomised controlled trial (PARK-BAND Study)
  1. Danielle Pessoa Lima1,2,
  2. Samuel Brito de Almeida3,
  3. Janine de Carvalho Bonfadini3,
  4. Emmanuelle Silva Tavares Sobreira3,
  5. Patrícia Gomes Damasceno4,
  6. Antonio Brazil Viana Júnior3,
  7. Madeleine Sales de Alencar1,
  8. João Rafael Gomes de Luna1,
  9. Pedro Gustavo Barros Rodrigues5,
  10. Isabelle de Sousa Pereira5,
  11. André Luis de Castro Gadelha6,
  12. Liliane Maria de Oliveira7,
  13. Érica Carneiro Barbosa Chaves7,
  14. Vlademir Carneiro Gomes8,
  15. Rayane Rodrigues Monteiro7,
  16. Thatyara Almeida de Macedo Costa9,
  17. Lucas Helal10,
  18. Joseph Signorile11,
  19. Lidiane Andréa Oliveira Lima12,
  20. Manoel Alves Sobreira-Neto4,
  21. Pedro Braga-Neto4,13
  1. 1Geriatric Division, Universidade Federal do Ceará, Hospital Universitário Walter Cantídio, Fortaleza, Brazil
  2. 2Medical School, Universidade de Fortaleza, Fortaleza, Brazil
  3. 3Clinical Research Unit, Universidade Federal do Ceará, Hospital Universitário Walter Cantídio, Fortaleza, Brazil
  4. 4Division of Neurology, Universidade Federal do Ceará, Hospital Universitário Walter Cantídio, Fortaleza, Brazil
  5. 5Medical School, Universidade Federal do Ceará, Hospital Universitário Walter Cantídio, Fortaleza, Brazil
  6. 6Psychology School, Universidade de Fortaleza, Centro de Ciências da Saúde, Fortaleza, Brazil
  7. 7School of Kinesiology, Universidade Estácio de Sá Sistema Integrado de Bibliotecas do Centro Universitário Estácio do Ceará, Fortaleza, Ceará, Brazil
  8. 8School of Kinesiology, Universidade Federal da Paraíba, Joao Pessoa, Brazil
  9. 9School of Nutrition, Universidade Estácio de Sá Sistema Integrado de Bibliotecas do Centro Universitário Estácio do Ceará, Fortaleza, Ceará, Brazil
  10. 10School of Kinesiology, Universidade do Extremo Sul Catarinense, Criciuma, Brazil
  11. 11Kinesiology and Sport Sciences, University of Miami, Coral Gables, Florida, USA
  12. 12Federal University of Ceará, Master Program in Physiotherapy and Functioning, Fortaleza, Brazil
  13. 13Medical School, Universidade Estadual do Ceará, Curso de Medicina, Fortaleza, Brazil
  1. Correspondence to Dr Danielle Pessoa Lima; dra.daniellelima{at}gmail.com

Abstract

Introduction Parkinson’s disease (PD) is the second most common neurodegenerative disorder in Brazil. Physical activity is a complementary intervention in managing inherent declines associated with the disease like strength, balance, gait, and functionality and benefit health-related outcomes. Here, we report the PARK-BAND Study protocol, which aims to investigate potential benefits of power training using elastic devices in participants with PD. Our intervention will be provided in patients with PD using elastic devices like elastic bands and tubes. Therefore, we used the term Park from Parkinson’s disease and band from elastic bands.

Methods and analysis This randomised single-blind single-centre two-arm parallel, superiority trial will include 50 participants with PD attending the clinical setting. Those who meet the eligibility criteria and provide consent to participate will be randomised in a 1:1 ratio to either the exercise group, which will receive power training programme or the health education group, which will receive the education programme. Randomisation will be performed by permuted block randomisation with a block size of eight. Both groups will receive a 12-week intervention. The exercise group will have two sessions per week and the health education group will have one session per week. Changes from baseline in bradykinesia, as assessed by the Unified Parkinson's Disease Rating Scale motor examination subscore and physical functional performance, will be the primary outcomes. Secondary outcomes include other neurological, neurophysiological and physical variables, as well as the quality of life, depression, cognition, sleep quality and disturbances, assessed before and after interventions. We hypothesise that the exercise group will have greater improvement in primary and secondary outcomes than the health education group.

Ethics and dissemination The study is approved by the Research Ethics Committee of Hospital Universitário Walter Cantidio and all participants will provide their written informed consent (register number 91075318.1.0000.5045).

Trial results will be disseminated via peer reviewed journal articles and conference presentations, reports for organisations involved with PD and for participants.

Trial registration number Registro Brasileiro de Ensaios Clínicos Registry (RBR-5w2sqt); Pre-results.

  • geriatric medicine
  • Parkinson's disease
  • rehabilitation medicine
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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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Footnotes

  • Twitter @helal_lucas

  • Correction notice This article has been corrected since it was published. Author name has been changed from Vlademir Gomes Carneiro to Vlademir Carneiro Gomes.

  • Contributors PB-N conceptualised the project and received funding. DPL, SBdA and JdCB were involved in designing the project. DPL and JdCB will be involved in the project implementation. ESTS will supervise the collection of outcomes. SBdA, along with VGC, will be involved in exercise intervention. LAOL supervised SBdA in developing an exercise protocol using elastic devices. PGD will apply neurological scales and interpret polysomnography. MASN will be involved in analysis and interpretation of data. ABVJ will perform statistical analysis of the data and randomisation. MSdA and JRGdL will coordinate the recruitment of participants meeting the eligibility criteria. JS helped with designing the project, statistics and exercise intervention. LH helped with designing and reviewing the project. ALdCG will be responsible for monitoring the intervention on recording of frequency, side effects and vital signs. PGBR and IdSP will record the results of the outcomes in the Redcap. ECBC and LMdO will collect data on physical performance, body composition and responses to other questionnaires. TAdMC and RRM will organise health education meetings. All authors helped draft the manuscript, read and approved the final version of the manuscript.

  • Funding Material support and scholarship grant for ESTS, SBdA, PGBR and IdSP: CNPq (Conselho Nacional de Desenvolvimento Científico e Tecnológico), CAPES (Fundação Cearense de Apoio Coordenação de Aperfeiçoamento de Pessoal de Nível Superior), FUNCAP–PDCTR (Fundação Cearense de Apoio–Programa de Desenvolvimento Científico e Tecnológico Regional (CNPq/Funcap)—EDITAL 07/2018 files’ numbers DC8-0145-00070.01.00/18 and 9917237/2018.

  • Competing interests None declared.

  • Patient consent for publication Obtained.

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

  • 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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