NCT02044887

Physical Activity to Patients With Dementia and Their Caregivers.

Physical Activity Program for Patients With Dementia and Their Relative Caregivers. Randomized Clinical Trial in Primary Health Care. APISDEMyF

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: Fundacion para la Investigacion y Formacion en Ciencias de la Salud · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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..

Conditions

• Impaired Cognition

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2014-01-01
• Primary completion: 2018-01-01
• Completion: 2018-01-01
• First posted: 2014-01-24
• Last updated: 2022-11-23

Locations

1 site across 1 country: Spain