Physical Exercise and Depressive Symptoms in Moderately or Severely Depressed Adults

NCT ID: NCT05703776

Last Updated: 2023-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-19

Study Completion Date

2022-05-01

Brief Summary

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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

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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)

Conditions

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Depressive Symptoms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

open randomized controlled trial
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Nordic Walking

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

Group Type EXPERIMENTAL

Nordic Walking

Intervention Type BEHAVIORAL

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.

control

no intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Grenoble Alps

OTHER

Sponsor Role collaborator

Je Bouge Pour Mon Moral

OTHER

Sponsor Role lead

Responsible Party

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Fabien Legrand

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fabien D Legrand, PhD

Role: STUDY_DIRECTOR

JBPMM

Locations

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association JBPMM

Nancy, , France

Site Status

Countries

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France

References

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

Reference Type BACKGROUND

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

Reference Type BACKGROUND

Other Identifiers

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JBPMM-1

Identifier Type: -

Identifier Source: org_study_id

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