NCT04019171

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2016

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 2, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 3, 2018

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 5, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 15, 2019

Completed
Last Updated

July 15, 2019

Status Verified

July 1, 2019

Enrollment Period

2.3 years

First QC Date

July 5, 2019

Last Update Submit

July 12, 2019

Conditions

Anxiety State

Outcome Measures

Primary Outcomes (1)

  • 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.

    before and after the 6 weeks of intervention

Study Arms (2)

interval exercise training

EXPERIMENTAL
Behavioral: exercise training

waiting list

NO INTERVENTION

Interventions

exercise trainingBEHAVIORAL

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)

interval exercise training

Eligibility Criteria

Age20 Years - 50 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 32436724DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Exercise

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 5, 2019

First Posted

July 15, 2019

Study Start

March 1, 2016

Primary Completion

July 2, 2018

Study Completion

September 3, 2018

Last Updated

July 15, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

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.