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Open Access Study protocol

Physical activity program for patients with dementia and their relative caregivers: randomized clinical trial in Primary Health Care (AFISDEMyF study)

Emiliano Rodriguez-Sánchez127*, José María Criado-Gutiérrez3, Sara Mora-Simón14, M Paz Muriel-Diaz1, Manuel A Gómez-Marcos12, José I Recio-Rodríguez1, M Carmen Patino-Alonso15, Luis F Valero-Juan16, José A Maderuelo-Fernandez1, Luis García-Ortiz12 and for the DERIVA Group

Author Affiliations

1 Primary Health Care Research Unit The Alamedilla. The Alamedilla Primary Health Center, Castilla-Leon Health Service–SACYL, IBSAL, Salamanca, Spain

2 Medicine Department, University of Salamanca, Salamanca, Spain

3 Department of Physiology and Pharmacology Department, University of Salamanca, Salamanca, Spain

4 Basic Psychology, Psychobiology and Behavioral Sciences Methodology Department, University of Salamanca, Salamanca, Spain

5 Statistics Department, University of Salamanca, Salamanca, Spain

6 Preventive Medicine, Public Health and Medical Microbiology Department, University of Salamanca, Salamanca, Spain

7 Unidad de Investigación, Centro de Salud La Alamedilla, 37003 Salamanca, Spain

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BMC Neurology 2014, 14:63  doi:10.1186/1471-2377-14-63

Published: 1 April 2014

Abstract

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.

Keywords:
Dementia; Caregivers; Physical activity; Pedometer; Cardiovascular risk