Physical Exercise and Depressive Symptoms in Moderately or Severely Depressed Adults (EXIMOS)
Primary Purpose
Depressive Symptoms
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Nordic Walking
Sponsored by
About this trial
This is an interventional supportive care trial for Depressive Symptoms focused on measuring add-on treatment
Eligibility Criteria
Inclusion Criteria: PHQ-9 (Kroenke et al., 2001) score of 10 or above Exclusion Criteria: medical contraindication to moderate-intensity aerobic exercise inability to read French language
Sites / Locations
- association JBPMM
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Nordic Walking
control
Arm Description
2 weekly sessions of supervised Nordic Walking in a city park with trees, grass, and ponds. Exercise intensity was set at 65%-75% of age-predicted maximal heart rate. The length of training was consecutive 10 weeks
no intervention
Outcomes
Primary Outcome Measures
change in the intensity of depressive symptoms
self-evaluated intensity of depressive symptoms. Was obtained using the standard Beck Depression Inventory (BDI-II; Beck et al., 1996)
Secondary Outcome Measures
Full Information
NCT ID
NCT05703776
First Posted
October 20, 2022
Last Updated
January 26, 2023
Sponsor
Je Bouge Pour Mon Moral
Collaborators
University Grenoble Alps
1. Study Identification
Unique Protocol Identification Number
NCT05703776
Brief Title
Physical Exercise and Depressive Symptoms in Moderately or Severely Depressed Adults
Acronym
EXIMOS
Official Title
Do Moderately and Severely Depressed Individuals Derive the Same Psychological Benefits From a 10-weeks Long Aerobic Exercise Program ?
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
January 19, 2022 (Actual)
Primary Completion Date
April 15, 2022 (Actual)
Study Completion Date
May 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Je Bouge Pour Mon Moral
Collaborators
University Grenoble Alps
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is a comparative trial comparing the time course of depressive symptoms between moderately and severely depressed participants over a 10-week long exercise program
Detailed Description
Sixty depressed French adults (34 with symptoms of moderate intensity and 26 with symptoms of severe intensity as defined by the PHQ-9 cutting scores) voluntarily participated in our comparative trial.
A control group (waiting list) of n = 16 including 8 severely depressed and 8 moderately depressed participants received no physical exercise.
For the remaining 44 participants (26 with moderate-intensity depressive symptoms and 18 with high-intensity depressive symptoms), two weekly Nordic Walking sessions of 1h were performed for 10 consecutive weeks.
Depressive symptoms were assessed using standard self-report questionnaires at various time points: 1/ enrollment (using the PHQ-9), and then (2) just before the beginning of the exercise intervention (pre-intervention; using the BDI-II), 2/ at the end of Week 5 (mid-intervention; using the BDI-II), and 3/ the day following the end of the exercise program (post-intervention)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Symptoms
Keywords
add-on treatment
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
open randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nordic Walking
Arm Type
Experimental
Arm Description
2 weekly sessions of supervised Nordic Walking in a city park with trees, grass, and ponds. Exercise intensity was set at 65%-75% of age-predicted maximal heart rate. The length of training was consecutive 10 weeks
Arm Title
control
Arm Type
No Intervention
Arm Description
no intervention
Intervention Type
Behavioral
Intervention Name(s)
Nordic Walking
Intervention Description
Nordic Walking (NW) is an aerobic physical activity where regular walking is enhanced by the addition of the active use of specifically designed NW poles. The physical strain is distributed in a balanced way to various muscle groups of the whole body.
Primary Outcome Measure Information:
Title
change in the intensity of depressive symptoms
Description
self-evaluated intensity of depressive symptoms. Was obtained using the standard Beck Depression Inventory (BDI-II; Beck et al., 1996)
Time Frame
10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
PHQ-9 (Kroenke et al., 2001) score of 10 or above
Exclusion Criteria:
medical contraindication to moderate-intensity aerobic exercise
inability to read French language
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabien D Legrand, PhD
Organizational Affiliation
JBPMM
Official's Role
Study Director
Facility Information:
Facility Name
association JBPMM
City
Nancy
ZIP/Postal Code
54000
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Data will be made available upon reasonable request. Requests for access to data from the study should be addressed to Fabien D. Legrand at fabien.legrand@univ-reims.fr. All proposals requesting data access will need to specify how it is planned to use the data, and all proposals will need approval of the study co- investigator team before data release.
Citations:
Citation
Beck AT, Steer RA, Brown GK. Beck Depression Inventory (2nd edition). San Antonio, TX: Hartcourt Brace, 1996.
Results Reference
background
Citation
Kroenke K, Spitzer RL. The PHQ-9: a new depression diagnostic and severity measure. Psychiatric Annals. 2002; 32: 509-521.
Results Reference
background
Learn more about this trial
Physical Exercise and Depressive Symptoms in Moderately or Severely Depressed Adults
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