Recruitment, retention, presence and adherence of a randomized controlled trial to evaluate the effects of task-specific training with individuals after stroke
DOI:
https://doi.org/10.1590/1809-2950/20008529012022PTKeywords:
Patient Selection, Treatment Adherence and Compliance, Randomized Controlled Trial, StrokeAbstract
Individuals with stroke benefit from different therapeutic strategies, which have proven their efficacy by conducting well-designed randomized controlled trials (RCTs). Understanding the study steps may assist researchers in conducting future RCTs. Thus, the objective of this study was to describe the process of recruitment, retention, presence and adherence in conducting an RCT performed with individuals in the chronic phase of stroke in the city of Belo Horizonte/MG/Brazil, with the purpose of investigating the efficacy of specific task training for both lower and upper limbs in improving the level of physical activity and mobility. Results showed that of the 674 potential participants, it was not possible to contact 240 individuals and 384 were not evaluated for not meeting the eligibility criteria. Fifty individuals participated in the clinical evaluation and 14 were not included in the study for the same reason. Thirty-six individuals started the interventions: recruitment rate of 5.3%. A retention rate of 80.6% was observed. Seven individuals left the study, mainly due to lack of interest in the activities. The attendance rate was 80.9%, being the main reason for missing medical appointments. The adherence rate was 82.7%, with 180 interruptions during sessions, being early leaving of the session the main reason. These results indicate some difficulties found in the process of conducting a RCT with individuals in the chronic phase of stroke involving the specific training of the task. Despite these difficulties, the proposed intervention can be considered
Downloads
References
Johnson W, Onuma O, Owolabi M, Sachdev S. Stroke: a global response is needed. Bull World Health Organ. 2016;94(9):634-4A. doi: 10.2471/BLT.16.181636
Pollock A, Baer G, Campbell P, Choo PL, Forster A, Morris J. et al. Physical rehabilitation approaches for the recovery of function and mobility following stroke. Cochrane Database Syst Rev. 2014;(4):CD001920. doi: 10.1002/14651858.CD001920.pub3
Jeon BJ, Kim WH, Park EY. Effect of task-oriented training for people with stroke: a meta-analysis focused on repetitive or circuit training. Top Stroke Rehabil. 2015;22(1):34-43. doi: 10.1179/1074935714Z.0000000035
Rensink M, Schuurmans M, Lindeman E, Hafsteinsdóttir T. Task-oriented training in rehabilitation after stroke: systematic review. J Adv Nurs. 2009;65(4):737-54. doi: 10.1111/j.1365-2648.2008.04925.x
Bayona NA, Bitensky J, Salter K, Teasell R. The Role of Task-Specific Training in Rehabilitation Therapies. Top Stroke Rehabil. 2005;12(3):58-65. doi: 10.1310/BQM5-6YGB-MVJ5-WVCR
French B, Thomas L, Leathley M, Sutton C, McAdam J, Forster A. et al. Does repetitive task training improve functional activity after stroke? A Cochrane systematic review and meta-analysis. J Rehabil Med. 2010;42(1):9-14. doi: 10.2340/16501977-0473
Farias NC, Michaelsen SM, Rodrigues LC. Treinamento da função bilateral de membros superiores em indivíduo com hemiparesia – estudo de caso. Conscientiae saúde. 2012;11(3):506-12. doi: 10.5585/ConsSaude.v11n3.3263
Barreca S, Sigouin C, Lambert C, Ansley B. Effects of Extra Training on the Ability of Stroke Survivors to Perform an Independent Sit-to-Stand: A Randomized Controlled Trial. J Geriatr Phys Ther. 2004;27(2):59-64. doi: 10.1519/00139143-200408000-00004
Salbach NM, Mayo NE, Wood-Dauphinee S, Hanley JA, Richards CL, Côté R. A task-orientated intervention enhances walking distance and speed in the first year post stroke: a randomized controlled trial. Clin Rehabil. 2004;18(5):509-19. doi: 10.1191/0269215504cr763oa
Lima LO, Rodrigues-de-Paula F. Recruitment rate, feasibility and safety of power training in individuals with Parkinson’s disease: a proof-of-concept study. Braz J Phys Ther. 2013;17(1):49-56. doi: 10.1590/s1413-35552012005000069
Gomes RP, Michaelsen SM, Rodrigues LC, Farias NC, Silva R. Pesquisas científicas com indivíduos pós Acidente Vascular Encefálico: dificuldades no recrutamento, alocação e aderência em dois diferentes protocolos de intervenção fisioterapêutica. Fisioter Pesqui. 2015;22(1):34-40. doi: 10.590/1809-2950/13111022012015
Scianni A, Teixeira-Salmela LF, Ada L. Challenges in recruitment, attendance and adherence of acute stroke survivors to a randomized trial in Brazil: a feasibility study. Braz J Phys Ther. 2012;16(1):40-5. doi: 10.1590/S1413-35552012000100008
Martins JC, Aguiar LT, Nadeau S, Scianni AA, Teixeira-Salmela LF, Faria CDCM. Efficacy of Task-Specific Training on Physical Activity Levels of People With Stroke: Protocol for a Randomized Controlled Trial. Phys Ther. 2017;97(6):640-8. doi: 10.1093/physth/pzx032
Pang M, Harris JE, Eng JJ. A Community-Based Upper-Extremity Group Exercise Program Improves Motor Function and Performance of Functional Activities in Chronic Stroke: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2006;87(1):01-09. doi: 10.1016/j.apmr.2005.08.113
Brashear A, Zafonte R, Corcoran M, Galvez-Jimenez N, Gracies JM, Gordon MF. et al. Inter-and intrarater reliability of the Ashworth Scale and the Disability Assessment Scale in patients with upper-limb poststroke spasticity. Arch Phys Med Rehabil. 2002;83(10):1349-54. doi: 10.1053/apmr.2002.35474
Centers for Disease Control and Prevention. Physical activity trends – United States, 1990–1998. MMWR Morb Mortal Wkly Rep. 2001;50:166-9. Disponível em: https://www.cdc.gov/mmwr/preview/mmwrhtml/mm5009a3.htm.
Bertolucci PHF, Brucki SMD, Campacci SR, Juliano Y. O Mini-Exame do Estado Mental em uma população geral: impacto da escolaridade. Arq Neuropsiquiatr. 1994;52(1):01-07. doi: 10.1590/S0004-282X1994000100001
Teixeira-Salmela LF, Devaraj R, Olney SJ. Validation of the human activity profile in stroke: A comparison of observed, proxy and self-reported scores. Disabil Rehabil. 2007;29(19):1518-24. doi: 10.1080/09638280601055733
American College Of Sports Medicine. ACSM’s: guidelines for exercise testing and prescription. 9th ed. Philadelphia: Lippincott Williams & Wilkins; 2014. Disponível em: http://antoinedl.com/fichiers/public/ACSM-guidelines-2014.pdf
Brkic L, Shaw L, Wijck FV, Francis R, Price C, Forster A. et al. Repetitive arm functional tasks after stroke (RAFTAS): a pilot randomised controlled trial. Pilot Feasibility Stud. 2016;2(1):1-12. doi: 10.1186/s40814-016-0088-5
Lima RCM. Efeitos da adição da restrição de tronco à terapia por contensão induzida modificada em ambiente domiciliar: um ensaio clínico aleatorizado. Belo Horizonte (MG): Universidade Federal de Minas Gerais; 2013. Disponível em: https://repositorio.ufmg.br/handle/1843/BUOS-97SJA5
Dean CM, Rissel C, Sherrington C, Sharkey M, Cumming RG, Lord SR. et al. Exercise to Enhance Mobility and Prevent Falls After Stroke. Neurorehabil Neural Repair. 2012;26(9):1046-57. doi: 10.1177/1545968312441711
Dean, CM, Richards CL, Malouin F. Task-related circuit training improves performance of locomotor tasks in chronic stroke: A randomized, controlled pilot trial. Arch Phys Med Rehabil. 2000;81(4):409-17. doi: 10.1053/mr.2000.3839
English CK, Hillier SL, Stiller KR, Warden-Flood A. Circuit Class Therapy Versus Individual Physiotherapy Sessions During Inpatient Stroke Rehabilitation: A Controlled Trial. Arch Phys Med Rehabil. 2007;88(8):955-63. doi: 10.1016/j.apmr.2007.04.010
Assumpção AM. Fatores associados à adesão de idosas em diferentes programas de exercícios terapêuticos. Belo Horizonte (MG): Universidade Federal de Minas Gerais; 2012. Disponível em: https://repositorio.ufmg.br/handle/1843/BUOS-8VWMV9
Downloads
Published
Issue
Section
License
Copyright (c) 2022 Paula da Cruz Peniche, Ana Paula da Silva Pinto, Raquel Lima Molinari Nassur Ribeiro, Júlia Caetano Martins, Christina Danielli Coelho de Morais Faria
This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License.
