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Completed

NCT Number: NCT02044887

Physical Activity to Patients With Dementia and Their Caregivers.

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Unidad de Investigación, Centro de Salud La Alamedilla.

Salamanca, 37003, Spain

About this study

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..

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: physical activity with an adapted physical activity program, PEPAF

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Fundacion para la Investigacion y Formacion en Ciencias de la Salud

Other

Registry information

Official study title

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

Acronym: AFISDEMyF

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Jan 24, 2014
Registry last updated
Nov 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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