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Effect of Physical Activity on Depressive Symptoms With a 5 Month Follow-up (2DPAP)

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ClinicalTrials.gov Identifier: NCT01995422
Recruitment Status : Completed
First Posted : November 26, 2013
Last Update Posted : April 1, 2015
Sponsor:
Collaborator:
Nantes University Hospital
Information provided by (Responsible Party):
Laboratory Motricité, Interactions, Performance

Study Description
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Brief 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. The secondary objectives are to test the effects of a physical activity on functional performance and to highlight psychological mechanisms.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Other: Physical activity program Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Effects of Physical Activity Program on the Emotional and Cognitive Dynamics in Major Depressive Disorder Patients
Study Start Date : December 2011
Actual Primary Completion Date : May 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Physical activity program
A 5-month follow-up including a 3-month period of supervised physical activity
 Other: Physical activity program
One hour sessions of active walking occurring three times a week during three months


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Distraction, self-efficacy and social support scores on 7-point Likert scales and balance on force platform [ Time Frame: Five months ]
    Exploration of underlying mechanisms associated with an expected decrease of depressive symptoms after a physical activity program concerning functional and psychological processes


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Speaking French
  • Aged between 18 and 65 years
  • Diagnosed with current major depressive disorder
  • BDI II score ≥ 12
  • IPAQ score <600

Exclusion Criteria:

  • Alcohol or substance(s) dependence(s)
  • Psychotic disorders
  • Anti-social personality
  • Pregnant or nursing women
  • Physical inability to perform active walking
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01995422


Locations
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France
University of Nantes
Nantes, Pays de la Loire, France, 44000
Sponsors and Collaborators
Laboratory Motricité, Interactions, Performance
Nantes University Hospital
Investigators
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Study Director: Marina Bourbousson, PhD Laboratory MIP
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Laboratory Motricité, Interactions, Performance
ClinicalTrials.gov Identifier: NCT01995422    
Other Study ID Numbers: 2011-A00934-37
First Posted: November 26, 2013    Key Record Dates
Last Update Posted: April 1, 2015
Last Verified: March 2015
Keywords provided by Laboratory Motricité, Interactions, Performance:
Major depressive disorder
Follow-up study
Ecological momentary assessment
Physical activity
Depression
 Self-esteem
Anxiety
Rumination
Quality of life
Additional relevant MeSH terms:
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Depressive Disorder
Depression
Depressive Disorder, Major
 Mood Disorders
Mental Disorders
Behavioral Symptoms