Clinical trial NCT06797830: Improving Core Strength in the Warfighter with a Novel Device
Official title: Improving Core Strength in the Warfighter with a Novel Device
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Core Strengthening
Posture
Low Back Pain
Keywords: AllCore
Lead sponsor: Mike O'Callaghan Military Hospital
Sponsor class: FED
First posted: 2025-01-29
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a prospective observational cohort using pre and post measurements of posture and core strength in subjects treated consistently with the AllCore360. The patients will act as their own control.
Primary purpose: TREATMENT

Brief summary: Low back pain is one of the most common chief complaints amongst adult patients in the ambulatory clinic and emergency settings and poor core strength is a known underlying cause/perpetuator. Additionally, it is one of the most common reasons active-duty military personnel seek medical care (absolute 2015; absolute 2016; absolute 2017). Moreover, musculoskeletal conditions represent a common reason service members are placed on limited duty and considered medically not fit to deploy. The AllCore360° has the potential to prevent pain and injury, decrease pain as well as reduce duty, fitness and mobility restrictions in active-duty members with low back pain.

Detailed description: Trunk control enables the body to stay upright while sitting and standing. Trunk muscles also respond to shifting weight during activity in order to keep the body balanced and to prevent falling over due to shifts in center-of-gravity. Trunk control is necessary to perform activities of daily living and to stave off low back pain to ensure servicemember optimal performance. Weakened trunk muscles are a symptom of conditions such as cerebral palsy and stroke as well as causing more common conditions such as low back pain (Karthikbabu; Emami). Military pilots with weak core muscles were associated with having significant low back pain (Yang). Chinese military recruits assigned to core muscle functional strength training intervention had half as many reports of low back pain as the control group and also reported increased lumbar endurance (Wang). After 9 weeks, military police officers given trunk training had significantly lower general musculoskeletal pain than control as well as increased trunk muscle endurance (Grani). A systematic review in 2021 concluded that core stability provides therapeutic effects in patients with nonspecific low back pain by reducing pain and disability and by improving quality of life measures (Frizziero).

AllCore360° is a novel core-strengthening machine intervention designed to target trunk muscles through gravity by means of high-intensity constant velocity rotating exercise (allcore360.com). AllCore360° is systematic, consistent and designed for use over time. The core is strengthened because a patient's core muscles are used in anterior, lateral, and posterior contractions sequentially during a single rotation (Palevo). The patient must resist gravity with the rotation as well as contract and fire isometrically to keep proper posture. Using proper posture, the patient must keep their back straight and neck neutral throughout the length of the intervention without relying on their lower body muscles at all (this is assisted by straps rendering the legs useless and by securing the pelvis in the chair). AllCore360° can be individualized so that the patient is sitting at a specific degree (0° to 90°), where lowering the degree increases the difficulty of keeping muscles activated to continuecorrect posture. Once secured to the machine, the patient spends a pre-specified number of minutes with their whole body spinning in a 360° arc at the pre-specified angle programmed into the machine, rotating clockwise, counter-clockwise, or both.

AllCore360° is a relatively new machine outside of high-performance sports and intense rehab, and as such there is little published literature evaluating it. Case reports do exist. One case report showed the impact a 14-week program of AllCore360° isometric trunk training had on a child with cerebral palsy, where upon completion the patient had improved trunk stability and motor function (Park). Another case series looked at the AllCore360°'s effect on trunk function, balance, and mobility after stroke, finding improved lateral control during standing and showing that an extended program of AllCore360° sessions is feasible and repeatable (Pilkar).

Eligibility criteria: \*\*Patients must be able to get care at Nellis Air Force Base (a military installation) in order to participate in this study\*\*

Inclusion Criteria:

* Healthy DoD beneficiaries at Nellis Air Force Base between the ages of 18 and 50 participating in Tactical Air Control Party Specialist (TACP) training program

Exclusion Criteria:

* Legally Authorized Representatives will not be utilized in this study.
* Current low back pain
* history of spinal surgery
* history of other serious spinal pathology (e.g. annular tears, spinal stenosis \[canal or neuroforaminal\], fracture, painful spinal arthritis)
* pregnancy

Primary outcomes:
measure: Posture
timeFrame: baseline/week 1 (visit 1), week 4 (visit 12), week 7 (visit 13)
measure: Core Strength
timeFrame: visit 1 (week), visit 2 (week 1), visit 3 (week 1); visit 4 (week 2), visit 5 (week 2), visit 6 (week 2); visit 7 (week 3), visit 8 (week 3), visit 9 (week 3); visit 10 (week 4), visit 11 (week 4), visit 12 (week 4); visit 13 (week 7)
Secondary outcomes:
measure: Core Strength -- AllCore degree setting
timeFrame: visit 1 (week), visit 2 (week 1), visit 3 (week 1); visit 4 (week 2), visit 5 (week 2), visit 6 (week 2); visit 7 (week 3), visit 8 (week 3), visit 9 (week 3); visit 10 (week 4), visit 11 (week 4), visit 12 (week 4); visit 13 (week 7)
Other outcomes:
Locations:
city: Nellis AFB
country: United States
facility: Mike O'Callaghan Military Medical Center
state: Nevada
Study officials:
References:
citation: Boland DM, Neufeld EV, Ruddell J, Dolezal BA, Cooper CB. Inter- and intra-rater agreement of static posture analysis using a mobile application. J Phys Ther Sci. 2016 Dec;28(12):3398-3402. doi: 10.1589/jpts.28.3398. Epub 2016 Dec 27.
citation: Cleland CL, Hunter RF, Kee F, Cupples ME, Sallis JF, Tully MA. Validity of the global physical activity questionnaire (GPAQ) in assessing levels and change in moderate-vigorous physical activity and sedentary behaviour. BMC Public Health. 2014 Dec 10;14:1255. doi: 10.1186/1471-2458-14-1255.
citation: Clark LL, Hu Z. Diagnoses of low back pain, active component, U.S. Armed Forces, 2010-2014. MSMR. 2015 Dec;22(12):8-11.
citation: Armed Forces Health Surveillance Branch. Absolute and relative morbidity burdens attributable to various illnesses and injuries, active component, U.S. Armed Forces, 2015. MSMR. 2016 Apr;23(4):2-7. No abstract available.
citation: Armed Forces Health Surveillance Branch. Absolute and relative morbidity burdens attributable to various illnesses and injuries, active component, U.S. Armed Forces, 2016. MSMR. 2017 Apr;24(4):2-8. No abstract available.
citation: Pilkar R, Veerubhotla A, Ibironke O, Ehrenberg N. A Novel Core Strengthening Intervention for Improving Trunk Function, Balance and Mobility after Stroke. Brain Sci. 2022 May 20;12(5):668. doi: 10.3390/brainsci12050668.
citation: Armed Forces Health Surveillance Branch. Absolute and relative morbidity burdens attributable to various illnesses and injuries, active component, U.S. Armed Forces, 2017. MSMR. 2018 May;25(5):2-9. No abstract available.
citation: Park, Eunse and Castle, Kimberly (2021) "The effect of an isometric trunk training during spinning in a child with Cerebral Palsy: A case report," Interprofessional Journal of Healthcare and Research: Vol. 1 , Article 4.
citation: Palevo, Gregory et al. Physiological Responses to Allcore360º Core Training System. Journal of Exercise Physiology. April 2022. Vol 24 Num 2.
citation: Grani G, Rodacki CLN, Lubas H, Resende EF, Hoinatski R, Sentone RG, Orr R, Paulo AC. Can training trunk musculature influence musculoskeletal pain and physical performance in military police officers? Ergonomics. 2022 Feb;65(2):265-275. doi: 10.1080/00140139.2021.1973576. Epub 2021 Sep 8.
citation: Frizziero A, Pellizzon G, Vittadini F, Bigliardi D, Costantino C. Efficacy of Core Stability in Non-Specific Chronic Low Back Pain. J Funct Morphol Kinesiol. 2021 Apr 22;6(2):37. doi: 10.3390/jfmk6020037.
citation: Wang X, Song WJ, Ruan Y, Li BC, Lu C, Huang N, Fang FF, Gu W. Core muscle functional strength training for reducing the risk of low back pain in military recruits: An open-label randomized controlled trial. J Integr Med. 2022 Mar;20(2):145-152. doi: 10.1016/j.joim.2021.12.002. Epub 2021 Dec 16.
citation: Yang Y, Liu S, Ling M, Ye C. Prevalence and Potential Risk Factors for Occupational Low Back Pain Among Male Military Pilots: A Study Based on Questionnaire and Physical Function Assessment. Front Public Health. 2022 Jan 4;9:744601. doi: 10.3389/fpubh.2021.744601. eCollection 2021.
citation: Emami F, Yoosefinejad AK, Razeghi M. Correlations between core muscle geometry, pain intensity, functional disability and postural balance in patients with nonspecific mechanical low back pain. Med Eng Phys. 2018 Oct;60:39-46. doi: 10.1016/j.medengphy.2018.07.006. Epub 2018 Aug 1.
citation: Karthikbabu S, Verheyden G. Relationship between trunk control, core muscle strength and balance confidence in community-dwelling patients with chronic stroke. Top Stroke Rehabil. 2021 Mar;28(2):88-95. doi: 10.1080/10749357.2020.1783896. Epub 2020 Jun 23.