Effectiveness of Exercise in the Treatment of Depression

Overview

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.

Full Title of Study: “Effectiveness of Exercise in the Treatment of Depression in Older People as an Alternative to Drugs Antidepressants in Primary Care”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 1, 2018

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).

Interventions

  • Other: Exercise

Arms, Groups and Cohorts

  • Experimental: Exercise
  • Active Comparator: Antidepressants

Clinical Trial Outcome Measures

Primary Measures

  • Improvement in depressive symptoms
    • Time Frame: 6 months

Participating in This Clinical Trial

Inclusion Criteria

  • People with depression Exclusion Criteria:

  • Contraindication to exercise

Gender Eligibility: All

Minimum Age: 65 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Gerencia de Atención Primaria, Albacete
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jesús López-Torres Hidalgo, MD – Gerencia de Atención Primaria, Albacete
  • Overall Official(s)
    • Jesús López-Torres Hidalgo, MD, Principal Investigator, Centro de Salud Zona VIII de Albacete (Spain)
  • Overall Contact(s)
    • Jesús López-Torres Hidalgo, MD, +34653137665, jesusl@sescam.org

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