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EXercise Training for Reducing Anxiety in First-Time Inmates (EXTRA)

Primary Purpose

Anxiety State

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
exercise training
Sponsored by
Université de Reims Champagne-Ardenne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety State

Eligibility Criteria

20 Years - 50 Years (Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • First-time prisoners ; elevated state anxiety (> 40 on the state anxiety inventory)

Exclusion Criteria:

  • Symptoms of and/or known cardiovascular, metabolic, psychiatric, neurological or neurodevelopmental disease

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    interval exercise training

    waiting list

    Arm Description

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    July 5, 2019
    Last Updated
    July 12, 2019
    Sponsor
    Université de Reims Champagne-Ardenne
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04019171
    Brief Title
    EXercise Training for Reducing Anxiety in First-Time Inmates
    Acronym
    EXTRA
    Official Title
    Interval Exercise Training for Reducing Anxiety in First-Time Inmates
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    March 1, 2016 (Actual)
    Primary Completion Date
    July 2, 2018 (Actual)
    Study Completion Date
    September 3, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Université de Reims Champagne-Ardenne

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anxiety State

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    43 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    interval exercise training
    Arm Type
    Experimental
    Arm Title
    waiting list
    Arm Type
    No Intervention
    Intervention Type
    Behavioral
    Intervention Name(s)
    exercise training
    Intervention Description
    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)
    Primary Outcome Measure Information:
    Title
    change in state anxiety
    Description
    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.
    Time Frame
    before and after the 6 weeks of intervention

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: First-time prisoners ; elevated state anxiety (> 40 on the state anxiety inventory) Exclusion Criteria: Symptoms of and/or known cardiovascular, metabolic, psychiatric, neurological or neurodevelopmental disease

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    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.
    Citations:
    PubMed Identifier
    32436724
    Citation
    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.
    Results Reference
    derived

    Learn more about this trial

    EXercise Training for Reducing Anxiety in First-Time Inmates

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