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

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Physical activity program
Sponsored by
Laboratory Motricité, Interactions, Performance
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Major Depressive Disorder focused on measuring Major depressive disorder, Follow-up study, Ecological momentary assessment, Physical activity, Depression, Self-esteem, Anxiety, Rumination, Quality of life

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Nantes

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Physical activity program

Arm Description

A 5-month follow-up including a 3-month period of supervised physical activity

Outcomes

Primary Outcome Measures

Effect of physical activity on depression
Evaluate the evolution of depressive symptoms in middle to severe depressive patients during a physical activity program

Secondary Outcome Measures

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

Full Information

First Posted
November 12, 2013
Last Updated
March 30, 2015
Sponsor
Laboratory Motricité, Interactions, Performance
Collaborators
Nantes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01995422
Brief Title
Effect of Physical Activity on Depressive Symptoms With a 5 Month Follow-up
Acronym
2DPAP
Official Title
Effects of Physical Activity Program on the Emotional and Cognitive Dynamics in Major Depressive Disorder Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laboratory Motricité, Interactions, Performance
Collaborators
Nantes University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Major depressive disorder, Follow-up study, Ecological momentary assessment, Physical activity, Depression, Self-esteem, Anxiety, Rumination, Quality of life

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Physical activity program
Arm Type
Experimental
Arm Description
A 5-month follow-up including a 3-month period of supervised physical activity
Intervention Type
Other
Intervention Name(s)
Physical activity program
Intervention Description
One hour sessions of active walking occurring three times a week during three months
Primary Outcome Measure Information:
Title
Effect of physical activity on depression
Description
Evaluate the evolution of depressive symptoms in middle to severe depressive patients during a physical activity program
Time Frame
Five months
Secondary Outcome Measure Information:
Title
Distraction, self-efficacy and social support scores on 7-point Likert scales and balance on force platform
Description
Exploration of underlying mechanisms associated with an expected decrease of depressive symptoms after a physical activity program concerning functional and psychological processes
Time Frame
Five months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marina Bourbousson, PhD
Organizational Affiliation
Laboratory MIP
Official's Role
Study Director
Facility Information:
Facility Name
University of Nantes
City
Nantes
State/Province
Pays de la Loire
ZIP/Postal Code
44000
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
26260007
Citation
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.
Results Reference
derived

Learn more about this trial

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

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