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Effectiveness of Exercise in the Treatment of Depression

NCT ID: NCT03358433

Last Updated: 2017-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

312 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-01

Study Completion Date

2018-12-31

Brief Summary

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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

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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).

Conditions

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Depression Primary Care Exercise

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Exercise

Group Type EXPERIMENTAL

Exercise

Intervention Type OTHER

Antidepressants

Group Type ACTIVE_COMPARATOR

Exercise

Intervention Type OTHER

Interventions

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Exercise

Intervention Type OTHER

Other Intervention Names

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Antidepressants

Eligibility Criteria

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Inclusion Criteria

* People with depression

Exclusion Criteria

* Contraindication to exercise
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gerencia de Atención Primaria, Albacete

OTHER

Sponsor Role lead

Responsible Party

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Jesús López-Torres Hidalgo

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jesús López-Torres Hidalgo, MD

Role: PRINCIPAL_INVESTIGATOR

Centro de Salud Zona VIII de Albacete (Spain)

Locations

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Jesús López-Torres Hidalgo

Albacete, , Spain

Site Status RECRUITING

Albacete, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Jesús López-Torres Hidalgo, MD

Role: CONTACT

Phone: +34653137665

Email: [email protected]

Facility Contacts

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Jesús López-Torres Hidalgo, MD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 34264835 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30642326 (View on PubMed)

Other Identifiers

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PI15/01486

Identifier Type: -

Identifier Source: org_study_id