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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04019171
Recruitment Status : Completed
First Posted : July 15, 2019
Last Update Posted : July 15, 2019
Information provided by (Responsible Party):
Fabien Legrand, Université de Reims Champagne-Ardenne

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

Condition or disease Intervention/treatment Phase
Anxiety State Behavioral: exercise training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Interval Exercise Training for Reducing Anxiety in First-Time Inmates
Actual Study Start Date : March 1, 2016
Actual Primary Completion Date : July 2, 2018
Actual Study Completion Date : September 3, 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: interval exercise training Behavioral: exercise training
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)

No Intervention: waiting list

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

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Responsible Party: Fabien Legrand, Professor, Université de Reims Champagne-Ardenne Identifier: NCT04019171     History of Changes
Other Study ID Numbers: Legrand_19_02
First Posted: July 15, 2019    Key Record Dates
Last Update Posted: July 15, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders