Major Depressive Disorder2DPAPNCT01995422
Effect of Physical Activity on Depressive Symptoms With a 5 Month Follow-up
A study testing Physical activity program in people with Major Depressive Disorder, run by Laboratory Motricité, Interactions, Performance at 1 site in France.
Trial summary
The main objective of this study is to evaluate the effect of a 12 weeks adapted physical activity program (active walking) on depression by analyzing the dynamics of emotional and cognitive functioning. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Physical activity program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2011to Jun 2014
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Speaking French
- Aged between 18 and 65 years
- Diagnosed with current major depressive disorder
- BDI II score ≥ 12
- IPAQ score <600
Who cannot join
- Alcohol or substance(s) dependence(s)
- Psychotic disorders
- Anti-social personality
- Pregnant or nursing women
- Physical inability to perform active walking
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Physical Activity Program on the Emotional and Cognitive Dynamics in Major Depressive Disorder Patients
The main objective of this study is to evaluate the effect of a 12 weeks adapted physical activity program (active walking) on depression by analyzing the dynamics of emotional and cognitive functioning. The secondary objectives are to test the effects of a physical activity on functional performance and to highlight psychological mechanisms.
Read the detailed description
Primary outcomes:
Self evaluations concerning global self-esteem, a perception of competence and satisfaction in the physical self and four sub-domains that are perceived physical endurance, perceived competence in sports, perceived physical force and perceived physical appearance, are performed.
Assessment of depressive symptomatology is also realised including momentary levels of depression, anxiety, rumination, efficacy of coping strategies and quality of life.
Secondary outcomes:
Assessment of postural control
- Conditions
- Major Depressive Disorder
- Being tested
- Physical activity program
- Keywords
- Major depressive disorder, Follow-up study, Ecological momentary assessment, Physical activity, Depression, Self-esteem, Anxiety, Rumination, Quality of life
- Medical subject headings
- Depressive Disorder, Major, Motor Activity, Depression, Anxiety Disorders, Rumination Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity programOther
One hour sessions of active walking occurring three times a week during three months
| Study group | Role | What they receive |
|---|---|---|
| Physical activity program | Experimental | A 5-month follow-up including a 3-month period of supervised physical activity Receives: Other: Physical activity program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of physical activity on depression
Evaluate the evolution of depressive symptoms in middle to severe depressive patients during a physical activity program
Measured: Five months
Secondary outcomes (1)
Distraction, self-efficacy and social support scores on 7-point Likert scales and balance on force platform
Exploration of underlying mechanisms associated with an expected decrease of depressive symptoms after a physical activity program concerning functional and psychological processes
Measured: Five months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2013 (estimated)
- Study startDec 2011
- Primary completionMay 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratory Motricité, Interactions, Performance
- Sponsor type
- University, hospital or other
- Collaborators
- Nantes University Hospital
- Responsible party
- Sponsor
- Investigators
- Marina Bourbousson, PhD, Study director, Laboratory MIP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01995422
- Sponsor's protocol ID
- 2011-A00934-37
- Acronym
- 2DPAP
- Status last verified
- Mar 2015
- First submitted
- 12 Nov 2013
- Last updated
- 1 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Deschamps T, Thomas-Ollivier V, Sauvaget A, Bulteau S, Fortes-Bourbousson M, Vachon H. Balance characteristics in patients with major depression after a two-month walking exercise program: A pilot study. Gait Posture. 2015 Oct;42(4):590-3. doi: 10.1016/j.gaitpost.2015.07.057. Epub 2015 Jul 31.
PubMed 26260007
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Physical Activity Program on the Emotional and Cognitive Dynamics in Major Depressive Disorder Patients
- ClinicalTrials.gov ID
- NCT01995422
- Acronym / sponsor ID
- 2DPAP / 2011-A00934-37
- Conditions
- Major Depressive Disorder
- Keywords
- Major depressive disorder, Follow-up study, Ecological momentary assessment, Physical activity, Depression, Self-esteem, Anxiety, Rumination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Laboratory Motricité, Interactions, PerformanceUniversity, hospital or other
- Collaborators
- Nantes University Hospital
- Study start
- Dec 2011
- Primary completion
- May 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 26 Nov 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 main objective of this study is to evaluate the effect of a 12 weeks adapted physical activity program (active walking) on depression by analyzing the dynamics of emotional and cognitive functioning. The secondary objectives are to test the effects of a physical activity on functional performance and to highlight psychological mechanisms.
Detailed description
Primary outcomes:
Self evaluations concerning global self-esteem, a perception of competence and satisfaction in the physical self and four sub-domains that are perceived physical endurance, perceived competence in sports, perceived physical force and perceived physical appearance, are performed.
Assessment of depressive symptomatology is also realised including momentary levels of depression, anxiety, rumination, efficacy of coping strategies and quality of life.
Secondary outcomes:
Assessment of postural control
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Physical activity program | Experimental | Other: Physical activity programA 5-month follow-up including a 3-month period of supervised physical activity |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Speaking French
- Aged between 18 and 65 years
- Diagnosed with current major depressive disorder
- BDI II score ≥ 12
- IPAQ score <600
Key exclusion criteria (5 listed)
- Alcohol or substance(s) dependence(s)
- Psychotic disorders
- Anti-social personality
- Pregnant or nursing women
- Physical inability to perform active walking
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 |
|---|---|---|
| Physical activity programOne hour sessions of active walking occurring three times a week during three months | Other | Physical activity program |
Primary outcome
Effect of physical activity on depression
Time frame: Five months
Evaluate the evolution of depressive symptoms in middle to severe depressive patients during a physical activity program
1 secondary outcome
Distraction, self-efficacy and social support scores on 7-point Likert scales and balance on force platform
Time frame: Five months
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 1 Apr 2015.
- Derived from this study: PubMed 26260007Deschamps T, Thomas-Ollivier V, Sauvaget A, Bulteau S, Fortes-Bourbousson M, Vachon H. Balance characteristics in patients with major depression after a two-month walking exercise program: A pilot study. Gait Posture. 2015 Oct;42(4):590-3. doi: 10.1016/j.gaitpost.2015.07.057. Epub 2015 Jul 31.
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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.
Marina Bourbousson, PhD study director
Laboratory MIP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity program in people with Major Depressive Disorder, run by Laboratory Motricité, Interactions, Performance at 1 site in France.
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 5 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 1 Apr 2015. 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 France. 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?
Effect of physical activity on depression (time frame: Five months). 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 NCT01995422, which also lists 1 linked publication.
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 1 Apr 2015.