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Status unknownNCT03358433DEP-EXERCISEUpdated Nov 30, 2017

Effectiveness of Exercise in the Treatment of Depression

An interventional study of Exercise in Depression, Primary Care and Exercise, sponsored by Gerencia de Atención Primaria, Albacete. Status unknown at 2 sites in Spain. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2017-11-30.

Sponsored by Gerencia de Atención Primaria, Albacete · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2017), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 1 year 5 months after the study started (first participant enrolled Jun 2016, registered Nov 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
312
Allocation
Randomized
Ages
65 Years and older
Sex
All
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Study 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.

Read the 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).

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Conditions studied

  • Depression
  • Primary Care
  • Exercise
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In context

Depression

8,245 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's planned enrollment of 312 is above the median of 84 across 6,869 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

Gerencia de Atención Primaria, Albacete is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • People with depression

Exclusion criteria

Exclusion Criteria:

  • Contraindication to exercise
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
312 participants (estimated)

Study arms

  • Experimental
    Exercise

    Other: Exercise

  • Active comparator
    Antidepressants

    Other: Exercise

Interventions

  • OtherExercise

    Also known as: Antidepressants

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What researchers measure

Primary outcomes

  1. Improvement in depressive symptoms

    Time frame: 6 months

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Study locations

2 of 2 sites recruiting
  • Jesús López-Torres Hidalgo
    Albacete, 02006, Spain
    Recruiting
  • Albacete, Spain
    Recruiting
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References and documents

Publications

  • Hidalgo JL, Sotos JR; DEP-EXERCISE Group. Effectiveness of Physical Exercise in Older Adults With Mild to Moderate Depression. Ann Fam Med. 2021 Jul-Aug;19(4):302-309. doi: 10.1370/afm.2670. PubMed 34264835 ↗
  • Lopez-Torres Hidalgo J; DEP-EXERCISE Group. Effectiveness of physical exercise in the treatment of depression in older adults as an alternative to antidepressant drugs in primary care. BMC Psychiatry. 2019 Jan 14;19(1):21. doi: 10.1186/s12888-018-1982-6. PubMed 30642326 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 30, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03358433
Lead sponsor
Gerencia de Atención Primaria, Albacete
Responsible party
Jesús López-Torres Hidalgo (MD, Gerencia de Atención Primaria, Albacete) — Principal investigator
First posted
Nov 30, 2017
Start date
Jun 1, 2016
Primary completion
Jun 1, 2018 (estimated)
Completion
Dec 31, 2018 (estimated)
Last update
Nov 30, 2017

Study contacts

Jesús López-Torres Hidalgo, MD
Contact
jesusl@sescam.org
+34653137665
Jesús López-Torres Hidalgo, MD
principal investigator · Centro de Salud Zona VIII de Albacete (Spain)
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

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