title: Physical activity program for patients with dementia and their relative caregivers: randomized clinical trial in Primary Health Care (AFISDEMyF study).
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
  
  
  
  METHODS
  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).
  
  
  METHODS
  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.
  
  
  METHODS
  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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  Clinical Trials.gov Identifier: NCT02044887.
authors.affiliation: Primary Health Care Research Unit The Alamedilla, The Alamedilla Primary Health Center, Castilla-Leon Health Service-SACYL, IBSAL, Salamanca, Spain. emiliano@usal.es.
authors.forename: Emiliano
authors.initials: E
authors.lastname: Rodriguez-Sánchez
authors.forename: José María
authors.initials: JM
authors.lastname: Criado-Gutiérrez
authors.forename: Sara
authors.initials: S
authors.lastname: Mora-Simón
authors.forename: M Paz
authors.initials: MP
authors.lastname: Muriel-Diaz
authors.forename: Manuel A
authors.initials: MA
authors.lastname: Gómez-Marcos
authors.forename: José I
authors.initials: JI
authors.lastname: Recio-Rodríguez
authors.forename: M Carmen
authors.initials: MC
authors.lastname: Patino-Alonso
authors.forename: Luis F
authors.initials: LF
authors.lastname: Valero-Juan
authors.forename: José A
authors.initials: JA
authors.lastname: Maderuelo-Fernandez
authors.forename: Luis
authors.initials: L
authors.lastname: García-Ortiz
mesh_terms: D017028:Caregivers; D003704:Dementia / Q000534:rehabilitation*; D006801:Humans; D026741:Physical Therapy Modalities; D012107:Research Design