PHYSICAL ACTIVITY AS A MEASURE OF IMPROVING THE EMOTIONAL STATE AND SOCIALIZATION IN THE ELDERLY

NCT04072185 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2019-08-28

No results posted yet for this study

Summary

Background: Social isolation, loneliness and anxiety-depressive states are emerging health conditions in the elderly of our society. This situation is related to higher morbidity and mortality. There is a growing need to determine effective interventions that address these situations, since sometimes pharmacological options are limited in these patients. Physical activity (AF) and social relationships in the elderly are linked to physical and mental health. Being able to do some physical or recreational activity will help them face this stage of life with more optimism and relate to others in a healthy and independent way, however, few studies have evaluated their effectiveness in our territory.

* Objectives: To evaluate whether a 4 month AF group program and the visit to know socio-cultural entities improve the emotional, social and quality of life situation in a sample of people over 64 years of age with anxiety, depression, social isolation or solitude And measure whether adherence to AF and the linkage to sociocultural entities is maintained after the intervention has taken place.
* Methodology:

Design: Multicentre, randomized, two-group clinical trial, of 1 year follow-up. Study population: Patients over 64 years of age assigned to primary care teams (EAP) from different locations: Sant Joan de Vilatorrada, Súria and Manresa 2.

Inclusion criteria: To meet criteria of depression or anxiety at the time of the study, score\> 12 on the Beck Depression Scale and / or score\> 10 on the GAD-7 Scale (General Anxiety Disorder) and that Present a score \<32 on the steps of DUKE-UNC-11.

A randomization of between 44 and 56 patients will be performed at each participant EAP. Half will be allocated to the control group (GC) and half to the intervention group (GI).

The intervention group will participate in a group AF program for 4 months. It will consist of 60 minutes of walking sessions 2 days a week. Also once a month, coinciding with the walk, you will visit some sociocultural municipal equipment to promote a community connection.

. Main measures: Response to the intervention or clinical remission of depression (Escalera de Beck), and / or anxiety (Escala GAD-7), improvement of social support (DUKE-UNC) and quality of life (EuroQol) . Secondary measures: Adherence to the AF (VREM questionnaire (Spanish Reduced Version of the Minnesota Free Time Questionnaire in Minnesota)), and linkage to sociocultural entities once the intervention has been completed. The assessments will be made at 0, 4, 8 and 12 months.

Conditions

Interventions

OTHER

Physical activity

TThe intervention group will participate in a group physical activity program for 4 months. It will consist of 60 minutes of walking sessions 2 days a week. The sessions will be directed by two referents of each primary care center. Also once a month, coinciding with the walk, you will visit some sociocultural municipal equipment to promote a community connection.

Sponsors & Collaborators

  • Institut Català de la Salut

    collaborator OTHER
  • Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

    lead OTHER

Principal Investigators

  • Jacobo Mendioroz, MD · Institut Català de la Salut

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-15
Primary Completion
2020-03-14
Completion
2020-09-14

Countries

  • Spain

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04072185 on ClinicalTrials.gov