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Trial record 22 of 33 for:    "Depressive Disorder" [DISEASE] AND Behavioral AND BDI | ( Map: Spain )

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

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ClinicalTrials.gov Identifier: NCT04072185
Recruitment Status : Active, not recruiting
First Posted : August 28, 2019
Last Update Posted : August 28, 2019
Sponsor:
Collaborator:
Institut Català de la Salut
Information provided by (Responsible Party):
Jordi Gol i Gurina Foundation

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.


Condition or disease Intervention/treatment Phase
Depression Anxiety Social Isolation Other: Physical activity Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Multicentre, randomized, two-group clinical trial, of 1 year follow-up.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CHANGES IN THE EMOTIONAL STATE, QUALITY OF LIFE AND SOCIAL SUPPORT AFTER A PROGRAM OF PHYSICAL ACTIVITY IN THE ELDERLY PEOPLE: RANDOMIZED MULTI-CENTER CLINICAL TRIAL
Actual Study Start Date : September 15, 2018
Estimated Primary Completion Date : March 14, 2020
Estimated Study Completion Date : September 14, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Physical activity group 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.

No Intervention: Control group



Primary Outcome Measures :
  1. Change from Baseline The Beck Depression Inventory score [ Time Frame: 4, 8 and 12 months after starting the study. ]
    Clinical remission is considered: Beck scale score (BDI-II) <12 points (Riedel 2010) and response to the intervention: reduction of the basal score.

  2. Change from Baseline General Anxiety Disorder-7 scale score [ Time Frame: 4, 8 and 12 months after starting the study. ]
    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

  3. Change from Baseline DUKE-UNC-11 social support questionnaire score [ Time Frame: 4, 8 and 12 months after starting the study. ]
    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. Change from Baseline EuroQol quality of life questionnaire score [ Time Frame: 4, 8 and 12 months after starting the study. ]
    Quality of life improvement is considered a decrease in the score in the EuroQol questionnaire with respect to basal.



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04072185


Locations
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Spain
Sant Joan de Vilatorrada Primary Care Center
Sant Joan de Vilatorrada, Barcelona, Spain, 08250
Sponsors and Collaborators
Jordi Gol i Gurina Foundation
Institut Català de la Salut
Investigators
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Study Chair: Jacobo Mendioroz, MD Institut Català de la Salut

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Responsible Party: Jordi Gol i Gurina Foundation
ClinicalTrials.gov Identifier: NCT04072185     History of Changes
Other Study ID Numbers: CEI 19/031-P
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jordi Gol i Gurina Foundation:
Physical activity
Primary Care
elderly people
anxiety
depression
social isolation
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms