Physical Activity to Patients With Dementia and Their Caregivers.

Not Applicable

Completed

• Conditions: Impaired Cognition
• Interventions: Other: physical activity

• Registration Number: NCT02044887
• Lead Sponsor: 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

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 Timeline

• Study Start: 2014-01-01
• Study First Submitted: 2014-01-21
• Study First Submitted QC: 2014-01-22
• Study First Posted: 2014-01-24
• Primary Completion: 2018-01-01
• Study Completion: 2018-01-01
• Status Verified: 2020-02
• Last Update Submitted: 2022-11-21
• Last Update Posted: 2022-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
INTERVENTION	physical activity	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.

Primary Outcome Measures

Name	Time	Method
Physical activity (podometer and 7-Day PAR) in patients and caregivers	12 months	The main measure will be the assessment of PA (podometer and 7-Day PAR) in patients and caregivers.

Secondary Outcome Measures

Name	Time	Method
ADAS-cog, functional degree and cardiovascular risk	12 months	In patients: ADAS-cog, functional degree and cardiovascular risk. In caregivers: cardiovascular risk, general health and quality of lif

Trial Locations

Locations (1)

Unidad de Investigación, Centro de Salud La Alamedilla.; 🇪🇸 Salamanca, Spain