Effect of Physical Activity on Depressive Symptoms With a 5 Month Follow-up

Major Depressive Disorder Clinical Trial

— 2DPAP  

Official title:

Effects of Physical Activity Program on the Emotional and Cognitive Dynamics in Major Depressive Disorder Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01995422
• Other study ID #: 2011-A00934-37
• Status: Completed
• Phase: N/A
• First received: November 12, 2013
• Last updated: March 30, 2015
• Start date: December 2011
• Est. completion date: June 2014

Study information

• Verified date: March 2015
• Source: Laboratory Motricité, Interactions, Performance
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: June 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Other:
• Physical activity program
One hour sessions of active walking occurring three times a week during three months

Locations

Country	Name	City	State
France	University of Nantes	Nantes	Pays de la Loire

Sponsors (2)

Lead Sponsor	Collaborator
Laboratory Motricité, Interactions, Performance	Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of physical activity on depression	Evaluate the evolution of depressive symptoms in middle to severe depressive patients during a physical activity program	Five months	Yes
Secondary	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	Five months	Yes