NCT02044887

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

January 21, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 24, 2014

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

November 23, 2022

Status Verified

February 1, 2020

Enrollment Period

4 years

First QC Date

January 21, 2014

Last Update Submit

November 21, 2022

Conditions

Impaired Cognition

Keywords

Physical activitydementiarelative caregiverspodometercardiovascular risk

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • ADAS-cog, functional degree and cardiovascular risk

    12 months

Study Arms (2)

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.

Other: physical activity

Control

NO INTERVENTION

The control group will receive regular care.

Interventions

physical activityOTHER

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.

Also known as: physical activity with an adapted physical activity program, PEPAF
INTERVENTION

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unidad de Investigación, Centro de Salud La Alamedilla.

Salamanca, 37003, Spain

Location

Related Publications (4)

  • 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.

    PMID: 22899425BACKGROUND

  • 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.

    PMID: 22439900BACKGROUND

  • 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.

    PMID: 22093337BACKGROUND

  • 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.

    PMID: 24684948DERIVED

MeSH Terms

Conditions

Cognition DisordersMotor ActivityDementia

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neurocognitive DisordersMental DisordersBehaviorBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Emiliano Rodriguez, MD

    Fundacion Infosalud

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2014

First Posted

January 24, 2014

Study Start

January 1, 2014

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

November 23, 2022

Record last verified: 2020-02

Locations

ES(1)