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Completed

NCT Number: NCT01995422

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Nantes

Nantes, Pays de la Loire Region, 44000, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical activity program

Other

One hour sessions of active walking occurring three times a week during three months

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Laboratory Motricité, Interactions, Performance

Other

Collaborators

  • Nantes University Hospital

Registry information

Official study title

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

Acronym: 2DPAP

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Nov 26, 2013
Registry last updated
Apr 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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