Effectiveness of Exercise in the Treatment of Depression

Not Applicable

• Conditions: Primary Care; Exercise; Depression
• Interventions: Other: Exercise

• Registration Number: NCT03358433
• Lead Sponsor: Gerencia de Atención Primaria, Albacete

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.

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 Timeline

• Study Start: 2016-06-01
• Status Verified: 2017-11
• Study First Submitted: 2017-11-25
• Study First Submitted QC: 2017-11-25
• Last Update Submitted: 2017-11-25
• Study First Posted: 2017-11-30
• Last Update Posted: 2017-11-30
• Primary Completion: 2018-06-01
• Study Completion: 2018-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 312

Inclusion Criteria

• People with depression

Exclusion Criteria

• Contraindication to exercise

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Antidepressants	Exercise	-
Exercise	Exercise	-

Primary Outcome Measures

Name	Time	Method
Improvement in depressive symptoms	6 months

Trial Locations

Locations (1)

Jesús López-Torres Hidalgo; 🇪🇸 Albacete, Spain