Clinical trial NCT05453110: Does Self-efficacy Predict Outcomes Among U.S. Military Academy Cadets During Initial Entry Training?
Official title: Does Self-efficacy Predict Outcomes Among U.S. Military Academy Cadets During Initial Entry Training?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Low Back Pain
Musculoskeletal Injury
Keywords: Nocebo
Self-Efficacy
Lead sponsor: Keller Army Community Hospital
Sponsor class: FED
First posted: 2022-07-12
Enrollment: 1200
Sex: ALL
Minimum age (years): 17
Maximum age (years): 26
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Mixed Design with Time Repeated and Group Between-Factor, Randomized Controlled Trial
Primary purpose: TREATMENT

Brief summary: Background:

Lower back injuries are a common occurrence in athletes, sports programs, and in the military (Bengtsson, 2018; Lovalekar, 2021). The Army's new fitness test includes a three-repetition maximum deadlift, and this inclusion has raised concern amongst servicemembers and healthcare workers due to the association between deadlifts and lower back injuries. There is debate amongst researchers about the role of deadlift form in lower back injury prevention, specifically related to flexion of the spine (Sjoberg, 2020).

Purpose:

The purpose of this study is to investigate the effect of low back pain education (either cautionary regarding injury risk or reassuring regarding spine resiliency) on deadlift performance (weight lifted), and if this education has an effect on self-efficacy and perceived spine vulnerability.

Participants:

Participants will be incoming new cadets at the United States Military Academy (USMA). Inclusion criteria are cadets age 17-26 (cadets under the age of 18 are legally emancipated therefore able to consent), those participating in the ACFT, and speak and understand English.

Study Design:

This study will be a randomized controlled trial with parallel design and 1:1 allocation ratio. The investigators plan to use cluster randomization. There will be three groups- control, cautionary, reassuring (Jackson, 2005). The investigators are also planning a prospective cohort study to assess self-efficacy, injury, and performance over time.

Procedures:

Data will be collected at the United States Military Academy during the summer of 2022 during cadet basic training. Shortly after new cadets arrive at USMA, the investigators will gather demographic and initial self-efficacy information. The randomized control element of this study will occur before and during the maximum deadlift (MDL) of the Army Combat Fitness Test (ACFT). At the start of cadet basic training, investigators will randomly allocate each company of cadets into one of three groups (three companies per group.) The investigator will administer the education (cautionary, reassuring, or control) shortly prior to cadets taking the MDL, and will collect results after the ACFT. The cautionary education is similar to standard information provided to many servicemembers before the start of an ACFT or a maximum deadlift.

Detailed description: Background:

Musculoskeletal injuries (MSKIs) are the leading cause of nondeployability, lost duty days (LDD), medical encounters, military discharge, and disability in the United States Military. (Lovalekar, 2021). Ironically, the leading causes of MSKIs are same activities that leaders deliberately conduct to develop physical resilience: running, foot marching, other physical fitness training activities (besides running) and work-related tasks (Lovalekar, 2021).

Purpose:

The purpose of this study is to learn about relationships between self-efficacy, injury and physical/tactical performance. The investigators also plan to assess the effect of low back pain education (either cautionary regarding injury risk or reassuring regarding spine resiliency) on deadlift performance (weight lifted), and if this education has an effect on self-efficacy and perceived spine vulnerability.

Participants:

Participants will be incoming new cadets at the United States Military Academy (USMA). Inclusion criteria are cadets age 17-26 (cadets under the age of 18 are legally emancipated therefore able to consent), those participating in the ACFT, and speak and understand English.

Study Design:

This study will be a randomized controlled trial with parallel design and 1:1 allocation ratio. The investigators plan to use cluster randomization. There will be three groups- control, cautionary, reassuring (Jackson, 2005). The investigators are also planning a prospective cohort study to assess self-efficacy, injury, and performance over time.

Procedures:

Data will be collected at the United States Military Academy during the summer of 2022 during cadet basic training. Shortly after new cadets arrive at USMA, the investigators will gather demographic and initial self-efficacy information. The randomized control element of this study will occur before and during the maximum deadlift (MDL) of the Army Combat Fitness Test (ACFT). At the start of cadet basic training, researchers will randomly allocate each company of cadets into one of three groups (three companies per group.) The researchers will administer the education (cautionary, reassuring, or control) shortly prior to cadets taking the MDL, and will collect results after the ACFT. The cautionary education is similar to standard information provided to many servicemembers before the start of an ACFT or a maximum deadlift.

Eligibility criteria: Inclusion Criteria:

* All incoming US Military Academy cadets, attending cadet basic training in summer 2022.

Exclusion Criteria:

* Unable to communicate in English; unable to participate in deadlift event.

Primary outcomes:
measure: Maximum Deadlift weight lifted
timeFrame: Day 1/Post-intervention
measure: Perceived spine vulnerability questionnaire
timeFrame: Day 1/Pre-Test
measure: Perceived spine vulnerability questionnaire
timeFrame: Day1/Post-Test
Secondary outcomes:
measure: Deadlift Self-Efficacy Questionnaire
timeFrame: Day 1/Post-Test
Other outcomes:
Locations:
city: West Point
country: United States
facility: Keller Army Community Hospital
state: New York
Study officials:
References:
citation: Jackson T, Pope L, Nagasaka T, Fritch A, Iezzi T, Chen H. The impact of threatening information about pain on coping and pain tolerance. Br J Health Psychol. 2005 Sep;10(Pt 3):441-51. doi: 10.1348/135910705X27587.
citation: Bengtsson V, Berglund L, Aasa U. Narrative review of injuries in powerlifting with special reference to their association to the squat, bench press and deadlift. BMJ Open Sport Exerc Med. 2018 Jul 17;4(1):e000382. doi: 10.1136/bmjsem-2018-000382. eCollection 2018.
citation: Lovalekar M, Hauret K, Roy T, Taylor K, Blacker SD, Newman P, Yanovich R, Fleischmann C, Nindl BC, Jones B, Canham-Chervak M. Musculoskeletal injuries in military personnel-Descriptive epidemiology, risk factor identification, and prevention. J Sci Med Sport. 2021 Oct;24(10):963-969. doi: 10.1016/j.jsams.2021.03.016. Epub 2021 Mar 31.
citation: Sjoberg H, Aasa U, Rosengren M, Berglund L. Content Validity Index and Reliability of a New Protocol for Evaluation of Lifting Technique in the Powerlifting Squat and Deadlift. J Strength Cond Res. 2020 Sep;34(9):2528-2536. doi: 10.1519/JSC.0000000000002791.