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
About this trial
This is an interventional treatment trial for Anxiety State
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
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
NCT ID
NCT04019171
First Posted
July 5, 2019
Last Updated
July 12, 2019
Sponsor
Université de Reims Champagne-Ardenne
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
We'll reach out to this number within 24 hrs