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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05703776
Other study ID # JBPMM-1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 19, 2022
Est. completion date May 1, 2022

Study information

Verified date January 2023
Source Je Bouge Pour Mon Moral
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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)


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date May 1, 2022
Est. primary completion date April 15, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Nordic Walking
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.

Locations

Country Name City State
France association JBPMM Nancy

Sponsors (2)

Lead Sponsor Collaborator
Je Bouge Pour Mon Moral University Grenoble Alps

Country where clinical trial is conducted

France, 

References & Publications (2)

Beck AT, Steer RA, Brown GK. Beck Depression Inventory (2nd edition). San Antonio, TX: Hartcourt Brace, 1996.

Kroenke K, Spitzer RL. The PHQ-9: a new depression diagnostic and severity measure. Psychiatric Annals. 2002; 32: 509-521.

Outcome

Type Measure Description Time frame Safety issue
Primary 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) 10 weeks
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