Physical Activity to Patients With Dementia and Their Caregivers. (AFISDEMyF)
Primary Purpose
Impaired Cognition
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
physical activity
Sponsored by
About this trial
This is an interventional treatment trial for Impaired Cognition focused on measuring Physical activity, dementia, relative caregivers, podometer, cardiovascular risk
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.
Sites / Locations
- Unidad de Investigación, Centro de Salud La Alamedilla.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
INTERVENTION
Control
Arm Description
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.
The control group will receive regular care.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Full Information
NCT ID
NCT02044887
First Posted
January 21, 2014
Last Updated
November 21, 2022
Sponsor
Fundacion para la Investigacion y Formacion en Ciencias de la Salud
1. Study Identification
Unique Protocol Identification Number
NCT02044887
Brief Title
Physical Activity to Patients With Dementia and Their Caregivers.
Acronym
AFISDEMyF
Official Title
Physical Activity Program for Patients With Dementia and Their Relative Caregivers. Randomized Clinical Trial in Primary Health Care. APISDEMyF
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2014 (Actual)
Primary Completion Date
January 1, 2018 (Actual)
Study Completion Date
January 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundacion para la Investigacion y Formacion en Ciencias de la Salud
4. Oversight
Data Monitoring Committee
No
5. Study Description
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..
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impaired Cognition
Keywords
Physical activity, dementia, relative caregivers, podometer, cardiovascular risk
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
140 (Actual)
8. Arms, Groups, and Interventions
Arm Title
INTERVENTION
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
The control group will receive regular care.
Intervention Type
Other
Intervention Name(s)
physical activity
Other Intervention Name(s)
physical activity with an adapted physical activity program, PEPAF
Intervention Description
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.
Primary Outcome Measure Information:
Title
Physical activity (podometer and 7-Day PAR) in patients and caregivers
Description
The main measure will be the assessment of PA (podometer and 7-Day PAR) in patients and caregivers.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
ADAS-cog, functional degree and cardiovascular risk
Description
In patients: ADAS-cog, functional degree and cardiovascular risk. In caregivers:
cardiovascular risk, general health and quality of lif
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emiliano Rodriguez, MD
Organizational Affiliation
Fundacion Infosalud
Official's Role
Principal Investigator
Facility Information:
Facility Name
Unidad de Investigación, Centro de Salud La Alamedilla.
City
Salamanca
ZIP/Postal Code
37003
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
22899425
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.
Results Reference
background
PubMed Identifier
22439900
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.
Results Reference
background
PubMed Identifier
22093337
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.
Results Reference
background
PubMed Identifier
24684948
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.
Results Reference
derived
Links:
URL
http://www.laalamedilla.org/Investigacion.htm
Description
Physical activity program for patients with dementia and their relative caregivers. AFISDEMYF
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Physical Activity to Patients With Dementia and Their Caregivers.
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