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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 web only file has been produced by the BMJ Publishing Group from an electronic file supplied by the author(s) and has not been edited for content.
Supplementary Data
This web only file has been produced by the BMJ Publishing Group from an electronic file supplied by the author(s) and has not been edited for content.
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.
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