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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
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..
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| INTERVENTION | Experimental | 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. |
|
| Control | No Intervention | The control group will receive regular care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| physical activity | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Physical activity (podometer and 7-Day PAR) in patients and caregivers | The main measure will be the assessment of PA (podometer and 7-Day PAR) in patients and caregivers. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| ADAS-cog, functional degree and cardiovascular risk | In patients: ADAS-cog, functional degree and cardiovascular risk. In caregivers: cardiovascular risk, general health and quality of lif | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emiliano Rodriguez, MD | Fundacion Infosalud | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unidad de Investigación, Centro de Salud La Alamedilla. | Salamanca | 37003 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22899425 | Background | 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. | |
| 22439900 |
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| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D009043 | Motor Activity |
| D003704 | Dementia |
| ID | Term |
|---|---|
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
| D001927 | Brain Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| 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. |
| 22093337 | Background | 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. |
| 24684948 | Derived | 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. |
| D002493 |
| Central Nervous System Diseases |
| D009422 | Nervous System Diseases |