Depressive SymptomsEXIMOSNCT05703776
Physical Exercise and Depressive Symptoms in Moderately or Severely Depressed Adults
A study testing Nordic Walking in people with Depressive Symptoms, run by Je Bouge Pour Mon Moral at 1 site in France.
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 Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Depressive Symptoms
- What is being tested?
- Nordic Walking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 19 Jan 2022to 1 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- PHQ-9 (Kroenke et al., 2001) score of 10 or above
Who cannot join
- medical contraindication to moderate-intensity aerobic exercise
- inability to read French language
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Do Moderately and Severely Depressed Individuals Derive the Same Psychological Benefits From a 10-weeks Long Aerobic Exercise Program ?
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
Read the 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)
- Conditions
- Depressive Symptoms
- Being tested
- Nordic Walking
- Keywords
- add-on treatment
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nordic WalkingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Nordic Walking |
| control | No intervention | no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2023
- Study start19 Jan 2022
- Primary completion15 Apr 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Depressive SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- open randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Je Bouge Pour Mon Moral
- Sponsor type
- University, hospital or other
- Collaborators
- University Grenoble Alps
- Responsible party
- Principal investigator, Fabien Legrand, Je Bouge Pour Mon Moral
- Investigators
- Fabien D Legrand, PhD, Study director, JBPMM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05703776
- Sponsor's protocol ID
- JBPMM-1
- Acronym
- EXIMOS
- Status last verified
- Jan 2023
- First submitted
- 20 Oct 2022
- Last updated
- 30 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Moderately and Severely Depressed Individuals Derive the Same Psychological Benefits From a 10-weeks Long Aerobic Exercise Program ?
- ClinicalTrials.gov ID
- NCT05703776
- Acronym / sponsor ID
- EXIMOS / JBPMM-1
- Conditions
- Depressive Symptoms
- Keywords
- add-on treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Je Bouge Pour Mon MoralUniversity, hospital or other
- Collaborators
- University Grenoble Alps
- Study start
- 19 Jan 2022 (actual)
- Primary completion
- 15 Apr 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 30 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- open randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Nordic Walking | Experimental | Behavioral: Nordic Walking2 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 |
| control | No intervention | –no intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- PHQ-9 (Kroenke et al., 2001) score of 10 or above
Key exclusion criteria (2 listed)
- medical contraindication to moderate-intensity aerobic exercise
- inability to read French language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nordic WalkingNordic 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. | Behavioural | Nordic Walking |
Primary outcome
change in the intensity of depressive symptoms
Time frame: 10 weeks
self-evaluated intensity of depressive symptoms. Was obtained using the standard Beck Depression Inventory (BDI-II; Beck et al., 1996)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2023.
- BackgroundBeck AT, Steer RA, Brown GK. Beck Depression Inventory (2nd edition). San Antonio, TX: Hartcourt Brace, 1996.
- BackgroundKroenke K, Spitzer RL. The PHQ-9: a new depression diagnostic and severity measure. Psychiatric Annals. 2002; 32: 509-521.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabien D Legrand, PhD study director
JBPMM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nordic Walking in people with Depressive Symptoms, run by Je Bouge Pour Mon Moral at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in the intensity of depressive symptoms (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05703776, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2023.