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Effectiveness of Exercise in the Treatment of Depression (DEP-EXERCISE)

Primary Purpose

Depression, Primary Care, Exercise

Status

Unknown status

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Exercise

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

People with depression

Exclusion Criteria:

Contraindication to exercise

Sites / Locations

Jesús López-Torres HidalgoRecruiting
Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Exercise

Antidepressants

Arm Description

Outcomes

Primary Outcome Measures

Improvement in depressive symptoms

Secondary Outcome Measures

Full Information

NCT ID

NCT03358433

First Posted

November 25, 2017

Last Updated

November 25, 2017

Sponsor

Gerencia de Atención Primaria, Albacete

1. Study Identification

Unique Protocol Identification Number

NCT03358433

Brief Title

Effectiveness of Exercise in the Treatment of Depression

Acronym

DEP-EXERCISE

Official Title

Effectiveness of Exercise in the Treatment of Depression in Older People as an Alternative to Drugs Antidepressants in Primary Care

Study Type

Interventional

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Unknown status

Study Start Date

June 1, 2016 (Actual)

Primary Completion Date

June 1, 2018 (Anticipated)

Study Completion Date

December 31, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Gerencia de Atención Primaria, Albacete

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depression, Primary Care, Exercise

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

312 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Exercise

Arm Type

Experimental

Arm Title

Antidepressants

Arm Type

Active Comparator

Intervention Type

Other

Intervention Name(s)

Exercise

Other Intervention Name(s)

Antidepressants

Primary Outcome Measure Information:

Title

Improvement in depressive symptoms

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: People with depression Exclusion Criteria: Contraindication to exercise

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jesús López-Torres Hidalgo, MD

Phone

+34653137665

jesusl@sescam.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jesús López-Torres Hidalgo, MD

Organizational Affiliation

Centro de Salud Zona VIII de Albacete (Spain)

Official's Role

Principal Investigator

Facility Information:

Facility Name

Jesús López-Torres Hidalgo

City

Albacete

ZIP/Postal Code

02006

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jesús López-Torres Hidalgo, MD

Phone

+34653137665

jesusl@sescam.org

City

Albacete

Country

Spain

Individual Site Status

Recruiting

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

34264835

Citation

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.

Results Reference

derived

PubMed Identifier

30642326

Citation

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.

Results Reference

derived

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Effectiveness of Exercise in the Treatment of Depression

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