NCT01899716

Brief Summary

The study aimed to evaluate the use of exercise as a complementary strategy to treat severe major depression in inpatients. Hypothesis: Exercise can be used as a safe and efficacious complimentary strategy in severe depressed inpatients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable depression

Timeline
Completed

Started Jan 2008

Longer than P75 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 13, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 15, 2013

Completed
Last Updated

December 30, 2013

Status Verified

May 1, 2013

Enrollment Period

4.9 years

First QC Date

June 13, 2013

Last Update Submit

December 27, 2013

Conditions

Depression

Keywords

Severe DepressionQuality of lifeExerciseBDNFTBARS

Outcome Measures

Primary Outcomes (1)

  • Depressive symptoms

    Hamilton 17 for depression

    2 weeks of hospitalization (14 days)

Secondary Outcomes (4)

  • Quality of Life

    Baseline, after 2 weeks of hospitalization and at discharge (participants will be followed for the duration of hospital stay, an expected average of 3 weeks)

  • Brain-Derived Neurotrophic Factor(BDNF)

    Baseline, after 2 weeks of hospitalization and at discharge (participants will be followed for the duration of hospital stay, an expected average of 3 weeks)

  • Thiobarbituric acid reactive substances(TBARS)

    Baseline, after 2 weeks of hospitalization and at discharge (participants will be followed for the duration of hospital stay, an expected average of 3 weeks)

  • Depressive symptoms at discharge (participants will be followed for the duration of hospital stay, an expected average of 3 weeks)

    Discharge

Study Arms (2)

Exercise

EXPERIMENTAL

Aerobic Exercise, 3 times peer week, A dose of 16.5 kcal/kg weight peer week.

Other: Exercise

Control

NO INTERVENTION

Interventions

ExerciseOTHER
Also known as: Aerobic Exercise
Exercise

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnosis of Major Depressive Disorder according to M.I.N.I (DSM-IV) criteria American Psychiatry Association(1994)
  • score of 25 or more on Hamilton-17
  • not being involved in other physical activity programs during the hospitalization
  • aged between 18 and 60 years
  • being able to read, understand, and provide written informed consent

You may not qualify if:

  • have three or more cardiovascular risk factors according to Physical Activity Readiness Questionnaire (PAR-Q)
  • are unable to exercise due other clinical condition
  • have diagnosis of Schizophrenia, Bipolar disorder or current use of alcohol or other drugs according to M.I.N.I DSM-IV criteria American Psychiatry Association(1994)
  • if they are taking beta-blocking medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Clincas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

Related Publications (2)

  • Schuch FB, Vasconcelos-Moreno MP, Borowsky C, Fleck MP. Exercise and severe depression: preliminary results of an add-on study. J Affect Disord. 2011 Oct;133(3):615-8. doi: 10.1016/j.jad.2011.04.030. Epub 2011 May 25.

    PMID: 21616540RESULT

  • Schuch FB, de Almeida Fleck MP. Is Exercise an Efficacious Treatment for Depression? A Comment upon Recent Negative Findings. Front Psychiatry. 2013 Apr 2;4:20. doi: 10.3389/fpsyt.2013.00020. eCollection 2013. No abstract available.

    PMID: 23565097RESULT

MeSH Terms

Conditions

DepressionMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Felipe B Schuch, MSc

    HCPA

    PRINCIPAL INVESTIGATOR

  • Marcelo PA Fleck, PhD

    HCPA

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2013

First Posted

July 15, 2013

Study Start

January 1, 2008

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

December 30, 2013

Record last verified: 2013-05

Locations

BR(1)