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

March 30, 2015 updated by: Laboratory Motricité, Interactions, Performance

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Pays de la Loire
      • Nantes, Pays de la Loire, France, 44000
        • University of Nantes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
Five months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laboratory Motricité, Interactions, Performance

Collaborators

Nantes University Hospital

Investigators

  • Study Director: Marina Bourbousson, PhD, Laboratory MIP

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

November 12, 2013

First Submitted That Met QC Criteria

November 21, 2013

First Posted (Estimate)

November 26, 2013

Study Record Updates

Last Update Posted (Estimate)

April 1, 2015

Last Update Submitted That Met QC Criteria

March 30, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-A00934-37

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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