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

Study Overview
=================
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

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

Conditions
-----------------
Major Depressive Disorder

Intervention / Treatment
-----------------
* Other: Physical activity program


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physical activity program<br>A 5-month follow-up including a 3-month period of supervised physical activity | Other: Physical activity program<br>* One hour sessions of active walking occurring three times a week during three months<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Major depressive disorder, Follow-up study, Ecological momentary assessment, Physical activity, Depression, Self-esteem, Anxiety, Rumination, Quality of life