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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03358433
Other study ID # PI15/01486
Secondary ID
Status Recruiting
Phase N/A
First received November 25, 2017
Last updated November 25, 2017
Start date June 1, 2016
Est. completion date December 31, 2018

Study information

Verified date November 2017
Source Gerencia de Atención Primaria, Albacete
Contact Jesús López-Torres Hidalgo, MD
Phone +34653137665
Email jesusl@sescam.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Recruiting
Enrollment 312
Est. completion date December 31, 2018
Est. primary completion date June 1, 2018
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria:

- People with depression

Exclusion Criteria:

- Contraindication to exercise

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Exercise


Locations

Country Name City State
Spain Jesús López-Torres Hidalgo Albacete

Sponsors (1)

Lead Sponsor Collaborator
Gerencia de Atención Primaria, Albacete

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Improvement in depressive symptoms 6 months
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