Cargando…
Physical activity program for patients with dementia and their relative caregivers: randomized clinical trial in Primary Health Care (AFISDEMyF study)
BACKGROUND: The aging of the population has led to the increase of chronic diseases, especially dementia and cardiovascular diseases, and it has become necessary for their relatives to dedicate more time in caregiving. The objective in the first phase of this study is to evaluate the effectiveness o...
Autores principales: | , , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2014
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3972512/ https://www.ncbi.nlm.nih.gov/pubmed/24684948 http://dx.doi.org/10.1186/1471-2377-14-63 |
_version_ | 1782309602196455424 |
---|---|
author | Rodriguez-Sánchez, Emiliano Criado-Gutiérrez, José María Mora-Simón, Sara Muriel-Diaz, M Paz Gómez-Marcos, Manuel A Recio-Rodríguez, José I Patino-Alonso, M Carmen Valero-Juan, Luis F Maderuelo-Fernandez, José A García-Ortiz, Luis |
author_facet | Rodriguez-Sánchez, Emiliano Criado-Gutiérrez, José María Mora-Simón, Sara Muriel-Diaz, M Paz Gómez-Marcos, Manuel A Recio-Rodríguez, José I Patino-Alonso, M Carmen Valero-Juan, Luis F Maderuelo-Fernandez, José A García-Ortiz, Luis |
author_sort | Rodriguez-Sánchez, Emiliano |
collection | PubMed |
description | BACKGROUND: The aging of the population has led to the increase of chronic diseases, especially dementia and cardiovascular diseases, and it has become necessary for their relatives to dedicate more time in caregiving. The objective in the first phase of this study is to evaluate the effectiveness of a Primary Health Care procedure to increase the physical activity of people with dementia and their relative caregivers. Also the effect on the cognitive state and cardiovascular risk will be assessed. METHODS/DESIGN: Design: Clinical, multicentric and randomized trial. A simple random sampling to select 134 patients diagnosed with dementia will be carried out. After contacting their relatives, his/her participation in the trial will be requested. A basal assessment will be made and the participants will be asigned to control or intervention group (1:1). Variables: The main measure will be the assessment of physical activity (podometer and 7-PAR) in patients and caregivers. In patients with dementia: ADAS-cog, functional degree and cardiovascular risk. In caregivers: cardiovascular risk, general health and quality of life. Intervention: For 3 months, participants will receive instructions to do physical activity with an adapted program. This program will be designed and applied by Primary Health Care professionals in patients with dementia and their caregivers. The control group will receive regular care. Analysis: An intention-to-treat analysis will be carried out by comparing the observed differences between basal, 6 and 12 months measures. Change in the mean of daily steps assessed with the podometer and 7-PAR will be the main result. DISCUSSION: If the main hypothesis is confirmed, it could be useful to improve the cognitive state of patients with dementia, as well as the cardiovascular risk of all of them. The results can be good to improve technical features of the devices that register the physical activity in the patients with dementia, and it could facilitate its commercialization. TRIAL REGISTRATION: Clinical Trials.gov Identifier: NCT02044887. |
format | Online Article Text |
id | pubmed-3972512 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2014 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-39725122014-04-03 Physical activity program for patients with dementia and their relative caregivers: randomized clinical trial in Primary Health Care (AFISDEMyF study) Rodriguez-Sánchez, Emiliano Criado-Gutiérrez, José María Mora-Simón, Sara Muriel-Diaz, M Paz Gómez-Marcos, Manuel A Recio-Rodríguez, José I Patino-Alonso, M Carmen Valero-Juan, Luis F Maderuelo-Fernandez, José A García-Ortiz, Luis BMC Neurol Study Protocol BACKGROUND: The aging of the population has led to the increase of chronic diseases, especially dementia and cardiovascular diseases, and it has become necessary for their relatives to dedicate more time in caregiving. The objective in the first phase of this study is to evaluate the effectiveness of a Primary Health Care procedure to increase the physical activity of people with dementia and their relative caregivers. Also the effect on the cognitive state and cardiovascular risk will be assessed. METHODS/DESIGN: Design: Clinical, multicentric and randomized trial. A simple random sampling to select 134 patients diagnosed with dementia will be carried out. After contacting their relatives, his/her participation in the trial will be requested. A basal assessment will be made and the participants will be asigned to control or intervention group (1:1). Variables: The main measure will be the assessment of physical activity (podometer and 7-PAR) in patients and caregivers. In patients with dementia: ADAS-cog, functional degree and cardiovascular risk. In caregivers: cardiovascular risk, general health and quality of life. Intervention: For 3 months, participants will receive instructions to do physical activity with an adapted program. This program will be designed and applied by Primary Health Care professionals in patients with dementia and their caregivers. The control group will receive regular care. Analysis: An intention-to-treat analysis will be carried out by comparing the observed differences between basal, 6 and 12 months measures. Change in the mean of daily steps assessed with the podometer and 7-PAR will be the main result. DISCUSSION: If the main hypothesis is confirmed, it could be useful to improve the cognitive state of patients with dementia, as well as the cardiovascular risk of all of them. The results can be good to improve technical features of the devices that register the physical activity in the patients with dementia, and it could facilitate its commercialization. TRIAL REGISTRATION: Clinical Trials.gov Identifier: NCT02044887. BioMed Central 2014-04-01 /pmc/articles/PMC3972512/ /pubmed/24684948 http://dx.doi.org/10.1186/1471-2377-14-63 Text en Copyright © 2014 Rodriguez-Sánchez et al.; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/4.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. |
spellingShingle | Study Protocol Rodriguez-Sánchez, Emiliano Criado-Gutiérrez, José María Mora-Simón, Sara Muriel-Diaz, M Paz Gómez-Marcos, Manuel A Recio-Rodríguez, José I Patino-Alonso, M Carmen Valero-Juan, Luis F Maderuelo-Fernandez, José A García-Ortiz, Luis Physical activity program for patients with dementia and their relative caregivers: randomized clinical trial in Primary Health Care (AFISDEMyF study) |
title | Physical activity program for patients with dementia and their relative caregivers: randomized clinical trial in Primary Health Care (AFISDEMyF study) |
title_full | Physical activity program for patients with dementia and their relative caregivers: randomized clinical trial in Primary Health Care (AFISDEMyF study) |
title_fullStr | Physical activity program for patients with dementia and their relative caregivers: randomized clinical trial in Primary Health Care (AFISDEMyF study) |
title_full_unstemmed | Physical activity program for patients with dementia and their relative caregivers: randomized clinical trial in Primary Health Care (AFISDEMyF study) |
title_short | Physical activity program for patients with dementia and their relative caregivers: randomized clinical trial in Primary Health Care (AFISDEMyF study) |
title_sort | physical activity program for patients with dementia and their relative caregivers: randomized clinical trial in primary health care (afisdemyf study) |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3972512/ https://www.ncbi.nlm.nih.gov/pubmed/24684948 http://dx.doi.org/10.1186/1471-2377-14-63 |
work_keys_str_mv | AT rodriguezsanchezemiliano physicalactivityprogramforpatientswithdementiaandtheirrelativecaregiversrandomizedclinicaltrialinprimaryhealthcareafisdemyfstudy AT criadogutierrezjosemaria physicalactivityprogramforpatientswithdementiaandtheirrelativecaregiversrandomizedclinicaltrialinprimaryhealthcareafisdemyfstudy AT morasimonsara physicalactivityprogramforpatientswithdementiaandtheirrelativecaregiversrandomizedclinicaltrialinprimaryhealthcareafisdemyfstudy AT murieldiazmpaz physicalactivityprogramforpatientswithdementiaandtheirrelativecaregiversrandomizedclinicaltrialinprimaryhealthcareafisdemyfstudy AT gomezmarcosmanuela physicalactivityprogramforpatientswithdementiaandtheirrelativecaregiversrandomizedclinicaltrialinprimaryhealthcareafisdemyfstudy AT reciorodriguezjosei physicalactivityprogramforpatientswithdementiaandtheirrelativecaregiversrandomizedclinicaltrialinprimaryhealthcareafisdemyfstudy AT patinoalonsomcarmen physicalactivityprogramforpatientswithdementiaandtheirrelativecaregiversrandomizedclinicaltrialinprimaryhealthcareafisdemyfstudy AT valerojuanluisf physicalactivityprogramforpatientswithdementiaandtheirrelativecaregiversrandomizedclinicaltrialinprimaryhealthcareafisdemyfstudy AT maderuelofernandezjosea physicalactivityprogramforpatientswithdementiaandtheirrelativecaregiversrandomizedclinicaltrialinprimaryhealthcareafisdemyfstudy AT garciaortizluis physicalactivityprogramforpatientswithdementiaandtheirrelativecaregiversrandomizedclinicaltrialinprimaryhealthcareafisdemyfstudy |