NCT01995422

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable major-depressive-disorder

Timeline
Completed

Started Dec 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

November 12, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 26, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

April 1, 2015

Status Verified

March 1, 2015

Enrollment Period

2.4 years

First QC Date

November 12, 2013

Last Update Submit

March 30, 2015

Conditions

Keywords

Major depressive disorderFollow-up studyEcological momentary assessmentPhysical activityDepressionSelf-esteemAnxietyRuminationQuality of life

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Distraction, self-efficacy and social support scores on 7-point Likert scales and balance on force platform

    Five months

Study Arms (1)

Physical activity program

EXPERIMENTAL

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

Other: Physical activity program

Interventions

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

Physical activity program

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Speaking French
  • Aged between 18 and 65 years
  • Diagnosed with current major depressive disorder
  • BDI II score ≥ 12
  • IPAQ score \<600

You may not qualify if:

  • Alcohol or substance(s) dependence(s)
  • Psychotic disorders
  • Anti-social personality
  • Pregnant or nursing women
  • Physical inability to perform active walking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nantes

Nantes, Pays de la Loire Region, 44000, France

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Depressive Disorder, MajorMotor ActivityDepressionAnxiety DisordersRumination Syndrome

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBehaviorBehavioral SymptomsGastrointestinal DiseasesDigestive System DiseasesFeeding and Eating Disorders

Study Officials

  • Marina Bourbousson, PhD

    Laboratory MIP

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2013

First Posted

November 26, 2013

Study Start

December 1, 2011

Primary Completion

May 1, 2014

Study Completion

June 1, 2014

Last Updated

April 1, 2015

Record last verified: 2015-03

Locations