Physical Activity to Patients With Dementia and Their Caregivers. (AFISDEMyF)
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|ClinicalTrials.gov Identifier: NCT02044887|
Recruitment Status : Unknown
Verified September 2014 by Fundacion para la Investigacion y Formacion en Ciencias de la Salud.
Recruitment status was: Recruiting
First Posted : January 24, 2014
Last Update Posted : September 5, 2014
Objective: To assess the effectiveness of an intervention in Primary Health Care to increase the physical activity (PA) and improve cognitive state and cardiovascular risk in patients with dementia and their relative caregivers.
The results can be used to improve the technical characteristics of the devices that record the physical activity of patients with dementia make marketing easier
|Condition or disease||Intervention/treatment||Phase|
|Impaired Cognition||Other: physical activity||Not Applicable|
Methodology: 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 assigned to control or intervention group (1:1). Variables: The main measure will be the assessment of PA (pedometer and 7-Day PAR) in patients and caregivers. In patients: 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 PA with an adapted PA program. This program will be designed and applied by Primary Health Care professionals in patients with dementia and 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 pedometer and 7-day PAR will If the main hypothesis is confirmed , it could be useful to improve the cardiovascular risk of all of them , as well as the cognitive state of patients with dementia..
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||134 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Physical Activity Program for Patients With Dementia and Their Relative Caregivers. Randomized Clinical Trial in Primary Health Care. APISDEMyF|
|Study Start Date :||January 2014|
|Estimated Primary Completion Date :||January 2015|
|Estimated Study Completion Date :||January 2015|
Participants will receive instructions to do physical activity with an adapted physical activity program. This program will be designed and applied by Primary Health Care professionals in patients with dementia and caregivers.
Other: physical activity
The characteristics of the PCD and CF and motivation will be evaluated to increase the AF through the (Test Prochaska-Diclemente). For 3 months will receive instructions to perform AF autonomously (walking, preferably in the vicinity of the place of residence). The intervention will be conducted by a professional of the health center so only couples of the intervention group will have knowledge of the specific recommendations of the AFISDEMYF. It is an intervention that has demonstrated its effectiveness in the PEPAF study (large, Sanchez et al. 2009) adapted, designed and implemented by primary care professionals for patients with dementia and for family members who care for them.
No Intervention: Control
The control group will receive regular care.
- Physical activity (podometer and 7-Day PAR) in patients and caregivers [ Time Frame: 12 months ]The main measure will be the assessment of PA (podometer and 7-Day PAR) in patients and caregivers.
- ADAS-cog, functional degree and cardiovascular risk [ Time Frame: 12 months ]
In patients: ADAS-cog, functional degree and cardiovascular risk. In caregivers:
cardiovascular risk, general health and quality of lif
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02044887
|Contact: Emiliano Rodriguez-Sánchez, MD||+34923290900 ext email@example.com|
|Contact: Sara Mora-Simon, PhD||+34923290900 ext firstname.lastname@example.org|
|Unidad de Investigación, Centro de Salud La Alamedilla.||Recruiting|
|Salamanca, Spain, 37003|
|Contact: Emiliano Rodriguez-Sanchez, MD +34923290900 ext 53346 email@example.com|
|Contact: Sara Mora-Simon, PhD +34923290900 ext 53550 firstname.lastname@example.org|
|Principal Investigator: Emiliano Rodriguez-Sanchez, MD|
|Sub-Investigator: Jose M Criado-Gutierrez-, MD|
|Sub-Investigator: Sara Mora-Simon, PhD|
|Sub-Investigator: María P Muriel-Diaz, M|
|Sub-Investigator: Cristina Agudo-Conde, Nurse|
|Sub-Investigator: Luix F Valero-Juan, MD|
|Sub-Investigator: Barbara Buch-Vicente, PhD|
|Sub-Investigator: Concepcion M Becerro-Muñoz, MD|
|Sub-Investigator: Jose A Iglesias-Valiente, M|
|Principal Investigator:||Emiliano Rodriguez, MD||Fundacion Infosalud|