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

NCT04072185 | Unknown

• 1 other identifier: CEI 19/031-P
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Depression; Anxiety; Social Isolation

Keywords

Physical activity; Primary Care; elderly people; anxiety; depression; social isolation

Outcome Measures

Primary Outcomes (4)

• Change from Baseline The Beck Depression Inventory score

  Clinical remission is considered: Beck scale score (BDI-II) \<12 points (Riedel 2010) and response to the intervention: reduction of the basal score.

  4, 8 and 12 months after starting the study.

• Change from Baseline General Anxiety Disorder-7 scale score

  Clinical remission is considered: scaling of the GAD-7 scale (General Anxiety Disorder) \<10 points and response to the intervention: reduction of the score compared to basal

  4, 8 and 12 months after starting the study.

• Change from Baseline DUKE-UNC-11 social support questionnaire score

  Social support improvement is considered a decrease in the score in the DUKE-UNC-11 social support questionnaire with respect to the basal, and good social support with a score \<32 points.

  4, 8 and 12 months after starting the study.

• Change from Baseline EuroQol quality of life questionnaire score

  Quality of life improvement is considered a decrease in the score in the EuroQol questionnaire with respect to basal.

  4, 8 and 12 months after starting the study.

Study Arms (2)

Physical activity group

EXPERIMENTAL

Other: Physical activity

Control group

NO INTERVENTION

Interventions

Physical activity OTHER

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.

Physical activity group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• score \> 12 on the Beck Depression Scale (BDI-II)
• and / or score \> 10 on the GAD-7 Scale (General Anxiety Disorder)
• and / or score \< 32 on the back of DUKE-UNC-11.

You may not qualify if:

• Diagnosis of dementia or moderate cognitive impairment.
• Greater depression (BECK scale score\> 28).
• Dependency disorders due to abuse of alcohol or other drugs.
• Participate in a therapy group of the hospital's psychiatry department.
• Physical illness at an advanced stage.
• Present any physical, mental or temporary limitations to be able to walk 1 hour a day two days a week.
• Not having signed the informed consent.

Sponsors & Collaborators

• Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina: lead
• Institut Català de la Salut: collaborator

Study Sites (1)

Sant Joan de Vilatorrada Primary Care Center

Sant Joan de Vilatorrada, Barcelona, 08250, Spain

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders; Social Isolation; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Social Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Jacobo Mendioroz, MD

  Institut Català de la Salut

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicentre, randomized, two-group clinical trial, of 1 year follow-up.

Study Record Dates

• First Submitted: July 19, 2019
• First Posted: August 28, 2019
• Study Start: September 15, 2018
• Primary Completion: March 14, 2020
• Study Completion: September 14, 2020
• Last Updated: August 28, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)