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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
Sponsor:
Information provided by (Responsible Party):
Fundacion para la Investigacion y Formacion en Ciencias de la Salud

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


Condition or disease Intervention/treatment Phase
Impaired Cognition Other: physical activity Not Applicable

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..


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 134 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: INTERVENTION
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.
Other Names:
  • physical activity with an adapted physical activity program
  • PEPAF
No Intervention: Control
The control group will receive regular care.



Primary Outcome Measures :
  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 Outcome Measures :
  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




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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Contacts
Contact: Emiliano Rodriguez-Sánchez, MD +34923290900 ext 53346 emiliano@usal.es
Contact: Sara Mora-Simon, PhD +34923290900 ext 53550 saramorasimon@gmail.com

Locations
Spain
Unidad de Investigación, Centro de Salud La Alamedilla. Recruiting
Salamanca, Spain, 37003
Contact: Emiliano Rodriguez-Sanchez, MD    +34923290900 ext 53346    emiliano@usal.es   
Contact: Sara Mora-Simon, PhD    +34923290900 ext 53550    saramorasimon@gmail.com   
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         
Sponsors and Collaborators
Fundacion para la Investigacion y Formacion en Ciencias de la Salud
Investigators
Principal Investigator: Emiliano Rodriguez, MD Fundacion Infosalud

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Fundacion para la Investigacion y Formacion en Ciencias de la Salud
ClinicalTrials.gov Identifier: NCT02044887     History of Changes
Other Study ID Numbers: GRS772/B/13
First Posted: January 24, 2014    Key Record Dates
Last Update Posted: September 5, 2014
Last Verified: September 2014

Keywords provided by Fundacion para la Investigacion y Formacion en Ciencias de la Salud:
Physical activity
dementia
relative caregivers
podometer
cardiovascular risk

Additional relevant MeSH terms:
Dementia
Cognitive Dysfunction
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders