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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

Tracking Information
First Submitted Date  ICMJE November 12, 2013
First Posted Date  ICMJE November 26, 2013
Last Update Posted Date April 1, 2015
Study Start Date  ICMJE December 2011
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 21, 2013)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 21, 2013)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Physical Activity on Depressive Symptoms With a 5 Month Follow-up
Official Title  ICMJE Effects of Physical Activity Program on the Emotional and Cognitive Dynamics in Major Depressive Disorder Patients
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE Other: Physical activity program
One hour sessions of active walking occurring three times a week during three months
Study Arms  ICMJE Experimental: Physical activity program
A 5-month follow-up including a 3-month period of supervised physical activity
Intervention: Other: Physical activity program
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 30, 2015)
16
Original Estimated Enrollment  ICMJE
 (submitted: November 21, 2013)
18
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01995422
Other Study ID Numbers  ICMJE 2011-A00934-37
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Laboratory Motricité, Interactions, Performance
Study Sponsor  ICMJE Laboratory Motricité, Interactions, Performance
Collaborators  ICMJE Nantes University Hospital
Investigators  ICMJE
Study Director: Marina Bourbousson, PhD Laboratory MIP
PRS Account Laboratory Motricité, Interactions, Performance
Verification Date March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP