Study protocol for a pilot randomised controlled trial evaluating the feasibility and effectiveness of non-pharmacological interventions to recover functionality after a transient ischaemic attack or a minor stroke: the 'Back to Normal' trial
Autor(a) principal: | |
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Data de Publicação: | 2023 |
Outros Autores: | , , , , |
Tipo de documento: | Artigo |
Idioma: | eng |
Título da fonte: | Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
Texto Completo: | https://hdl.handle.net/10216/154320 |
Resumo: | Introduction Transient ischaemic attack (TIA) and minor stroke are frequently assumed as temporary or non-disabling events. However, evidence suggests that these patients can experience relevant impairment and functional disability. Therefore, the present study aims to evaluate the feasibility and effectiveness of a 3-month multidomain intervention programme, composed of five non-pharmacological strategies, aimed at accelerating return to pre-event level of functionality in patients with TIA or minor stroke. Methods and analysis Patients diagnosed with a TIA or a minor stroke are being recruited at the emergency or neurology departments of the Hospital Pedro Hispano, located in Matosinhos, Portugal (n=70). Those who accept to participate will be randomly allocated to two groups (1:1): (a) Intervention-receives a 3 months combined approach, initiating early post-event, composed of cognitive training, physical exercise, nutrition, psychoeducation and assessment/correction of hearing loss; (b) Control-participants will not be subject to any intervention. Both groups will receive the usual standard of care provided to these diseases. Recruitment began in May 2022 and is expected to continue until March 2023. Socio-demographic characteristics, lifestyles, health status, cognitive function, symptoms of anxiety and depression and quality of life will be assessed; as well as anthropometry, blood pressure and physical condition. Time to complete or partial recovery of instrumental activities of daily living will be assessed using an adapted version of the Frenchay Activities Index. All participants will be evaluated before the intervention and after 3 months. Ethics and dissemination This study was approved by the Ethics Committee of the Local Health Unit of Matosinhos (Ref. 75/CES/JAS). Written informed consent will be required from all the participants; data protection and confidentiality will be also ensured. The findings of this project are expected to be submitted for publication in scientific articles, and the main results will be presented at relevant scientific meetings. Trial registration number NCT05369637. |
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Study protocol for a pilot randomised controlled trial evaluating the feasibility and effectiveness of non-pharmacological interventions to recover functionality after a transient ischaemic attack or a minor stroke: the 'Back to Normal' trialStrokePUBLIC HEALTHPREVENTIVE MEDICINEIntroduction Transient ischaemic attack (TIA) and minor stroke are frequently assumed as temporary or non-disabling events. However, evidence suggests that these patients can experience relevant impairment and functional disability. Therefore, the present study aims to evaluate the feasibility and effectiveness of a 3-month multidomain intervention programme, composed of five non-pharmacological strategies, aimed at accelerating return to pre-event level of functionality in patients with TIA or minor stroke. Methods and analysis Patients diagnosed with a TIA or a minor stroke are being recruited at the emergency or neurology departments of the Hospital Pedro Hispano, located in Matosinhos, Portugal (n=70). Those who accept to participate will be randomly allocated to two groups (1:1): (a) Intervention-receives a 3 months combined approach, initiating early post-event, composed of cognitive training, physical exercise, nutrition, psychoeducation and assessment/correction of hearing loss; (b) Control-participants will not be subject to any intervention. Both groups will receive the usual standard of care provided to these diseases. Recruitment began in May 2022 and is expected to continue until March 2023. Socio-demographic characteristics, lifestyles, health status, cognitive function, symptoms of anxiety and depression and quality of life will be assessed; as well as anthropometry, blood pressure and physical condition. Time to complete or partial recovery of instrumental activities of daily living will be assessed using an adapted version of the Frenchay Activities Index. All participants will be evaluated before the intervention and after 3 months. Ethics and dissemination This study was approved by the Ethics Committee of the Local Health Unit of Matosinhos (Ref. 75/CES/JAS). Written informed consent will be required from all the participants; data protection and confidentiality will be also ensured. The findings of this project are expected to be submitted for publication in scientific articles, and the main results will be presented at relevant scientific meetings. Trial registration number NCT05369637.BMJ Publishing Group20232023-01-01T00:00:00Zinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleapplication/pdfhttps://hdl.handle.net/10216/154320eng2044-605510.1136/bmjopen-2022-069593Gonçalves, MLima, MJFonseca, ADuque, CCosta, ARCruz, VTinfo:eu-repo/semantics/openAccessreponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãoinstacron:RCAAP2023-11-29T12:59:03Zoai:repositorio-aberto.up.pt:10216/154320Portal AgregadorONGhttps://www.rcaap.pt/oai/openaireopendoar:71602024-03-19T23:30:59.593576Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãofalse |
dc.title.none.fl_str_mv |
Study protocol for a pilot randomised controlled trial evaluating the feasibility and effectiveness of non-pharmacological interventions to recover functionality after a transient ischaemic attack or a minor stroke: the 'Back to Normal' trial |
title |
Study protocol for a pilot randomised controlled trial evaluating the feasibility and effectiveness of non-pharmacological interventions to recover functionality after a transient ischaemic attack or a minor stroke: the 'Back to Normal' trial |
spellingShingle |
Study protocol for a pilot randomised controlled trial evaluating the feasibility and effectiveness of non-pharmacological interventions to recover functionality after a transient ischaemic attack or a minor stroke: the 'Back to Normal' trial Gonçalves, M Stroke PUBLIC HEALTH PREVENTIVE MEDICINE |
title_short |
Study protocol for a pilot randomised controlled trial evaluating the feasibility and effectiveness of non-pharmacological interventions to recover functionality after a transient ischaemic attack or a minor stroke: the 'Back to Normal' trial |
title_full |
Study protocol for a pilot randomised controlled trial evaluating the feasibility and effectiveness of non-pharmacological interventions to recover functionality after a transient ischaemic attack or a minor stroke: the 'Back to Normal' trial |
title_fullStr |
Study protocol for a pilot randomised controlled trial evaluating the feasibility and effectiveness of non-pharmacological interventions to recover functionality after a transient ischaemic attack or a minor stroke: the 'Back to Normal' trial |
title_full_unstemmed |
Study protocol for a pilot randomised controlled trial evaluating the feasibility and effectiveness of non-pharmacological interventions to recover functionality after a transient ischaemic attack or a minor stroke: the 'Back to Normal' trial |
title_sort |
Study protocol for a pilot randomised controlled trial evaluating the feasibility and effectiveness of non-pharmacological interventions to recover functionality after a transient ischaemic attack or a minor stroke: the 'Back to Normal' trial |
author |
Gonçalves, M |
author_facet |
Gonçalves, M Lima, MJ Fonseca, A Duque, C Costa, AR Cruz, VT |
author_role |
author |
author2 |
Lima, MJ Fonseca, A Duque, C Costa, AR Cruz, VT |
author2_role |
author author author author author |
dc.contributor.author.fl_str_mv |
Gonçalves, M Lima, MJ Fonseca, A Duque, C Costa, AR Cruz, VT |
dc.subject.por.fl_str_mv |
Stroke PUBLIC HEALTH PREVENTIVE MEDICINE |
topic |
Stroke PUBLIC HEALTH PREVENTIVE MEDICINE |
description |
Introduction Transient ischaemic attack (TIA) and minor stroke are frequently assumed as temporary or non-disabling events. However, evidence suggests that these patients can experience relevant impairment and functional disability. Therefore, the present study aims to evaluate the feasibility and effectiveness of a 3-month multidomain intervention programme, composed of five non-pharmacological strategies, aimed at accelerating return to pre-event level of functionality in patients with TIA or minor stroke. Methods and analysis Patients diagnosed with a TIA or a minor stroke are being recruited at the emergency or neurology departments of the Hospital Pedro Hispano, located in Matosinhos, Portugal (n=70). Those who accept to participate will be randomly allocated to two groups (1:1): (a) Intervention-receives a 3 months combined approach, initiating early post-event, composed of cognitive training, physical exercise, nutrition, psychoeducation and assessment/correction of hearing loss; (b) Control-participants will not be subject to any intervention. Both groups will receive the usual standard of care provided to these diseases. Recruitment began in May 2022 and is expected to continue until March 2023. Socio-demographic characteristics, lifestyles, health status, cognitive function, symptoms of anxiety and depression and quality of life will be assessed; as well as anthropometry, blood pressure and physical condition. Time to complete or partial recovery of instrumental activities of daily living will be assessed using an adapted version of the Frenchay Activities Index. All participants will be evaluated before the intervention and after 3 months. Ethics and dissemination This study was approved by the Ethics Committee of the Local Health Unit of Matosinhos (Ref. 75/CES/JAS). Written informed consent will be required from all the participants; data protection and confidentiality will be also ensured. The findings of this project are expected to be submitted for publication in scientific articles, and the main results will be presented at relevant scientific meetings. Trial registration number NCT05369637. |
publishDate |
2023 |
dc.date.none.fl_str_mv |
2023 2023-01-01T00:00:00Z |
dc.type.status.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article |
format |
article |
status_str |
publishedVersion |
dc.identifier.uri.fl_str_mv |
https://hdl.handle.net/10216/154320 |
url |
https://hdl.handle.net/10216/154320 |
dc.language.iso.fl_str_mv |
eng |
language |
eng |
dc.relation.none.fl_str_mv |
2044-6055 10.1136/bmjopen-2022-069593 |
dc.rights.driver.fl_str_mv |
info:eu-repo/semantics/openAccess |
eu_rights_str_mv |
openAccess |
dc.format.none.fl_str_mv |
application/pdf |
dc.publisher.none.fl_str_mv |
BMJ Publishing Group |
publisher.none.fl_str_mv |
BMJ Publishing Group |
dc.source.none.fl_str_mv |
reponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação instacron:RCAAP |
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Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação |
instacron_str |
RCAAP |
institution |
RCAAP |
reponame_str |
Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
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Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
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Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação |
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1799135619178299392 |