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Effectiveness of Exercise in the Treatment of Depression (DEP-EXERCISE)

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ClinicalTrials.gov Identifier: NCT03358433
Recruitment Status : Unknown
Verified November 2017 by Jesús López-Torres Hidalgo, Gerencia de Atención Primaria, Albacete.
Recruitment status was:  Recruiting
First Posted : November 30, 2017
Last Update Posted : November 30, 2017
Sponsor:
Information provided by (Responsible Party):
Jesús López-Torres Hidalgo, Gerencia de Atención Primaria, Albacete

Study Description
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Brief Summary:
The main objective is to test the non-inferiority of supervised exercise versus antidepressant treatment in reducing depressive symptoms in patients with clinical criteria for depression (according to ICD 10) over a period of 6 months follow-up.

Condition or disease Intervention/treatment Phase
Depression Primary Care Exercise Other: Exercise Not Applicable

Detailed Description:
This is a randomized clinical trial in primary care in which a total of 312 patients over 65 years with clinically significant depression will be randomly assigned to an exercise program supervised or receive treatment with antidepressant drugs commonly used in clinical practice. At baseline physical fitness of the participants will be checked, and assessments will be made after 15 days and 1, 3 and 6 months. The supervised exercise program will consist of 2 sessions per week in groups of 10-12 patients over a 6 month period in which a sports instructor will train patients to perform at least 30 minutes of regular, moderate-intensity activity with a frequency almost daily, including aerobic exercise and strength training, flexibility and balance. In both groups will be evaluated periodically, among other variables, the state of depressive symptoms, level of physical activity, self-rated health, occurrence of adverse effects and adherence to exercise program or antidepressant treatment. The main outcome measure is the reduction of the baseline score on the scales of depressive symptoms (Montgomery-Asberg Depression Rating Scale and Geriatric Depression Scale).
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 312 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of Exercise in the Treatment of Depression in Older People as an Alternative to Drugs Antidepressants in Primary Care
Actual Study Start Date : June 1, 2016
Estimated Primary Completion Date : June 1, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Exercise Other: Exercise
Other Name: Antidepressants
Active Comparator: Antidepressants Other: Exercise
Other Name: Antidepressants


Outcome Measures
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Primary Outcome Measures :
  1. Improvement in depressive symptoms [ Time Frame: 6 months ]

Eligibility Criteria
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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:

  • People with depression

Exclusion Criteria:

  • Contraindication to exercise
Contacts and Locations
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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): NCT03358433


Contacts
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Contact: Jesús López-Torres Hidalgo, MD +34653137665 jesusl@sescam.org

Locations
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Spain
Jesús López-Torres Hidalgo Recruiting
Albacete, Spain, 02006
Contact: Jesús López-Torres Hidalgo, MD    +34653137665    jesusl@sescam.org   
Recruiting
Albacete, Spain
Sponsors and Collaborators
Gerencia de Atención Primaria, Albacete
Investigators
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Principal Investigator: Jesús López-Torres Hidalgo, MD Centro de Salud Zona VIII de Albacete (Spain)
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Jesús López-Torres Hidalgo, MD, Gerencia de Atención Primaria, Albacete
ClinicalTrials.gov Identifier: NCT03358433    
Other Study ID Numbers: PI15/01486
First Posted: November 30, 2017    Key Record Dates
Last Update Posted: November 30, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
 Mental Disorders
Antidepressive Agents
Psychotropic Drugs