Anxiety StateEXTRANCT04019171
EXercise Training for Reducing Anxiety in First-Time Inmates
A study testing exercise training in people with Anxiety State, run by Université de Reims Champagne-Ardenne.
Trial summary
Clinical trial with 2 arms ("interval exercise training" or "waiting list") aiming at evaluating the anxiolytic effects of a 6 weeks-long exercise training program in first-time prisoners with elevated anxiety symtpoms Read more about this study
- Who is it for?
- Ages 20 to 50 years, men only
- Conditions the study is for
- Anxiety State
- What is being tested?
- exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2016to 3 Sep 2018
- 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 20 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- First-time prisoners ; elevated state anxiety (> 40 on the state anxiety inventory)
Who cannot join
- Symptoms of and/or known cardiovascular, metabolic, psychiatric, neurological or neurodevelopmental disease
About this study
Official title: Interval Exercise Training for Reducing Anxiety in First-Time Inmates
Clinical trial with 2 arms ("interval exercise training" or "waiting list") aiming at evaluating the anxiolytic effects of a 6 weeks-long exercise training program in first-time prisoners with elevated anxiety symtpoms
- Conditions
- Anxiety State
- Being tested
- exercise training
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise trainingBehavioural
6 weeks of physical exercise training. 3 sessions per week. Session duration : 40 minutes. Self-regulated exercise intensity using Borg's ratings of perceived exertion (RPE)
| Study group | Role | What they receive |
|---|---|---|
| interval exercise training | Experimental | Not described Receives: Behavioral: exercise training |
| waiting list | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in state anxiety
pre- to post-intervention change in the State Anxiety Inventory score (STAI; Spielberger et al., 1993). The STAI has 20 items assessed on a 4-point Likert scale ranging from 1 (not at all) to 4 (most intensive). Consequently, the range of possible scores is 20-80.
Measured: before and after the 6 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2019
- Study start1 Mar 2016
- Primary completion2 Jul 2018
- Study completion3 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anxiety StateStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Reims Champagne-Ardenne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fabien Legrand, Université de Reims Champagne-Ardenne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04019171
- Sponsor's protocol ID
- Legrand_19_02
- Acronym
- EXTRA
- Status last verified
- Jul 2019
- First submitted
- 5 Jul 2019
- Last updated
- 15 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: statistical data (anxiety means and standard deviations before and after intervention) will be available in the form of a scientific paper in an academic journal for the participants in the active group (exercise) as well as for participants in the no intervention group (waiting list). No individual data will be published.
Publications
Legrand FD, Ory E, Herring MP. Evaluation of a brief interval exercise training (IET) intervention for first-time prisoners with elevated anxiety symptoms. Anxiety Stress Coping. 2020 Sep;33(5):581-589. doi: 10.1080/10615806.2020.1768244. Epub 2020 May 21.
PubMed 32436724
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interval Exercise Training for Reducing Anxiety in First-Time Inmates
- ClinicalTrials.gov ID
- NCT04019171
- Acronym / sponsor ID
- EXTRA / Legrand_19_02
- Conditions
- Anxiety State
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Université de Reims Champagne-ArdenneUniversity, hospital or other
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 2 Jul 2018 (actual)
- Study completion
- 3 Sep 2018 (actual)
- First posted
- 15 Jul 2019 (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.
Clinical trial with 2 arms ("interval exercise training" or "waiting list") aiming at evaluating the anxiolytic effects of a 6 weeks-long exercise training program in first-time prisoners with elevated anxiety symtpoms
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| interval exercise training | Experimental | Behavioral: exercise training |
| waiting list | No intervention | – |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- First-time prisoners ; elevated state anxiety (> 40 on the state anxiety inventory)
Key exclusion criteria (1 listed)
- Symptoms of and/or known cardiovascular, metabolic, psychiatric, neurological or neurodevelopmental disease
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 |
|---|---|---|
| exercise training6 weeks of physical exercise training. 3 sessions per week. Session duration : 40 minutes. Self-regulated exercise intensity using Borg's ratings of perceived exertion (RPE) | Behavioural | interval exercise training |
Primary outcome
change in state anxiety
Time frame: before and after the 6 weeks of intervention
pre- to post-intervention change in the State Anxiety Inventory score (STAI; Spielberger et al., 1993). The STAI has 20 items assessed on a 4-point Likert scale ranging from 1 (not at all) to 4 (most intensive). Consequently, the range of possible scores is 20-80.
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 15 Jul 2019.
- Derived from this study: PubMed 32436724Legrand FD, Ory E, Herring MP. Evaluation of a brief interval exercise training (IET) intervention for first-time prisoners with elevated anxiety symptoms. Anxiety Stress Coping. 2020 Sep;33(5):581-589. doi: 10.1080/10615806.2020.1768244. Epub 2020 May 21.
- Individual participant dataSharing planned: No. statistical data (anxiety means and standard deviations before and after intervention) will be available in the form of a scientific paper in an academic journal for the participants in the active group (exercise) as well as for participants in the no intervention group (waiting list). No individual data will be published.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing exercise training in people with Anxiety State, run by Université de Reims Champagne-Ardenne.
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 1 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 15 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
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 state anxiety (time frame: before and after the 6 weeks of intervention). 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 NCT04019171, which also lists 1 linked publication.
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 15 Jul 2019.