Clinical trial NCT02044887: Physical Activity to Patients With Dementia and Their Caregivers.
Official title: Physical Activity Program for Patients With Dementia and Their Relative Caregivers. Randomized Clinical Trial in Primary Health Care. APISDEMyF
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Impaired Cognition
Keywords: Physical activity
dementia
relative caregivers
podometer
cardiovascular risk
Lead sponsor: Fundacion para la Investigacion y Formacion en Ciencias de la Salud
Sponsor class: OTHER
First posted: 2014-01-24
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: 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..

Eligibility criteria: Inclusion Criteria:

* patient with dementia residing in a home in the area of the health center.
* identification of family members, or friends (not professional caregiver), who provide most of the care to the PCD.
* completion of informed consent on the part of the caregiver (and PCD) where appropriate.
* the PCD does not take drugs that may negatively affect cognitive function during the period of intervention.

Exclusion Criteria:

* mental disorders due to diseases, medical or related substances (DSM-IV-TR).
* stages of dementia (6 or 7 GDS),
* Delirum.
* comorbidity that prevents performing the exercise program intervention: unstable heart disease, bedridden, need walkers or wheelchair, diseases significant stroke, bone and muscle disorders, major psychiatric, neurological or metabolic alterations.
* severe clinical events within the 6 months prior.
* on waiting list of surgical interventions or treatments that require a hospital stay, or forecast stays out of the capital more than 4 weeks during the intervention.
* the caregiver dissent to participate in the trial.
* participants who submit any psychological or general medical condition which in the opinion of the investigator may impede the fulfilment of the questionnaires in the Protocol
* participants who are participating at the time of the start of the study in a clinical trial or study with medications.

Primary outcomes:
measure: Physical activity (podometer and 7-Day PAR) in patients and caregivers
timeFrame: 12 months
Secondary outcomes:
measure: ADAS-cog, functional degree and cardiovascular risk
timeFrame: 12 months
Other outcomes:
Locations:
city: Salamanca
country: Spain
facility: Unidad de Investigación, Centro de Salud La Alamedilla.
Study officials:
affiliation: Fundacion Infosalud
name: Emiliano Rodriguez, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rodriguez-Sanchez E, Patino-Alonso MC, Mora-Simon S, Gomez-Marcos MA, Perez-Penaranda A, Losada-Baltar A, Garcia-Ortiz L. Effects of a psychological intervention in a primary health care center for caregivers of dependent relatives: a randomized trial. Gerontologist. 2013 Jun;53(3):397-406. doi: 10.1093/geront/gns086. Epub 2012 Aug 16.
citation: Garcia-Garcia A, Gomez-Marcos MA, Recio-Rodriguez JI, Patino-Alonso MC, Rodriguez-Sanchez E, Agudo-Conde C, Garcia-Ortiz L; Vaso-risk group. Office and 24-hour heart rate and target organ damage in hypertensive patients. BMC Cardiovasc Disord. 2012 Mar 22;12:19. doi: 10.1186/1471-2261-12-19.
citation: Rodriguez-Sanchez E, Mora-Simon S, Patino-Alonso MC, Garcia-Garcia R, Escribano-Hernandez A, Garcia-Ortiz L, Perea-Bartolome MV, Gomez-Marcos MA. Prevalence of cognitive impairment in individuals aged over 65 in an urban area: DERIVA study. BMC Neurol. 2011 Nov 17;11:147. doi: 10.1186/1471-2377-11-147.
citation: Rodriguez-Sanchez E, Criado-Gutierrez JM, Mora-Simon S, Muriel-Diaz MP, Gomez-Marcos MA, Recio-Rodriguez JI, Patino-Alonso MC, Valero-Juan LF, Maderuelo-Fernandez JA, Garcia-Ortiz L; DERIVA Group. Physical activity program for patients with dementia and their relative caregivers: randomized clinical trial in Primary Health Care (AFISDEMyF study). BMC Neurol. 2014 Apr 1;14:63. doi: 10.1186/1471-2377-14-63.