NCT05703776

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

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

January 19, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2022

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 20, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 30, 2023

Completed
Last Updated

January 30, 2023

Status Verified

January 1, 2023

Enrollment Period

3 months

First QC Date

October 20, 2022

Last Update Submit

January 26, 2023

Conditions

Keywords

add-on treatment

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Nordic Walking

EXPERIMENTAL

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

Behavioral: Nordic Walking

control

NO INTERVENTION

no intervention

Interventions

Nordic WalkingBEHAVIORAL

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.

Nordic Walking

Eligibility Criteria

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

You may qualify if:

  • PHQ-9 (Kroenke et al., 2001) score of 10 or above

You may not qualify if:

  • medical contraindication to moderate-intensity aerobic exercise
  • inability to read French language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

association JBPMM

Nancy, 54000, France

Location

Related Publications (2)

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

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

    BACKGROUND

MeSH Terms

Conditions

Depression

Interventions

Nordic Walking

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

WalkingLocomotionMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExerciseMotor Activity

Study Officials

  • Fabien D Legrand, PhD

    JBPMM

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: open randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

October 20, 2022

First Posted

January 30, 2023

Study Start

January 19, 2022

Primary Completion

April 15, 2022

Study Completion

May 1, 2022

Last Updated

January 30, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

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.

Locations