DepressionNCT01899716
Exercise and Severe Depression: Clinical and Biological Analysis
A study testing Exercise in people with Depression, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Depression
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2008to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clincas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903
About this study
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.
- Conditions
- Depression
- Being tested
- Exercise
- Keywords
- Severe Depression, Quality of life, Exercise, BDNF, TBARS
- Medical subject headings
- Depression, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Also called Aerobic Exercise
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Aerobic Exercise, 3 times peer week, A dose of 16.5 kcal/kg weight peer week. Receives: Other: Exercise |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive symptoms
Hamilton 17 for depression
Measured: 2 weeks of hospitalization (14 days)
Secondary outcomes (4)
Quality of Life
WHOQOL-BREF
Measured: 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)
Measured: 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)
Measured: 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)
Hamilton Scores at discharge
Measured: Discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2013 (estimated)
- Study startJan 2008
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Felipe B Schuch, MSc, Principal investigator, HCPAMarcelo PA Fleck, PhD, Study director, HCPA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01899716
- Sponsor's protocol ID
- 07-438
- Status last verified
- May 2013
- First submitted
- 13 Jun 2013
- Last updated
- 30 Dec 2013
- Results posted
- No
Publications
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.
PubMed 21616540Schuch 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.
PubMed 23565097
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise and Severe Depression: Clinical and Biological Analysis
- ClinicalTrials.gov ID
- NCT01899716
- Acronym / sponsor ID
- 07-438
- Conditions
- Depression
- Keywords
- Severe Depression, Quality of life, Exercise, BDNF, TBARS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 15 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Other: ExerciseAerobic Exercise, 3 times peer week, A dose of 16.5 kcal/kg weight peer week. |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseAlso: Aerobic Exercise | Other | Exercise |
Primary outcome
Depressive symptoms
Time frame: 2 weeks of hospitalization (14 days)
Hamilton 17 for depression
4 secondary outcomes
Quality of Life
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2013.
- Results publication: PubMed 21616540Schuch 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.
- Results publication: PubMed 23565097Schuch 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.
Related trials for Depression
RecruitingPhase 1
Mechanism of Action Underlying Ketamine's Antidepressant Effects: The AMPA Throughput Theory in Patients With Treatment-Resistant Major Depression
Depression, Major Depressive Disorder
Recruiting
To Improve Depressive Symptoms Using a Web-App
Depression
Active, not recruiting
Supporting Health in Veterans With Heart Failure
Heart Failure
Recruiting
Cancer Pain Management Using a Web-based Intervention
Cancer of Breast, Depressive Symptoms
Recruiting
Risk and Resilience to Suicide Following Late-Life Spousal Bereavement
Suicide, Bereavement
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Felipe B Schuch, MSc principal investigator
HCPA
Marcelo PA Fleck, PhD study director
HCPA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Depression, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depressive symptoms (time frame: 2 weeks of hospitalization (14 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01899716, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2013.