NCT02362243

Brief Summary

Purpose and Aims: The purpose of this study is to assess the clinical effectiveness of back and core exercise interventions for low back injury prevention in firefighters. Aim 1. Compare the effectiveness of 2 worksite exercise interventions (supervised, web-based) relative to control to reduce lost work days related to low back injury and illness in firefighters. Relevance: Low back injury is one of the most common and disabling disorders in firefighters. Thus, novel interventions are needed to counteract the adverse consequences of this disorder and its impact on firefighter safety. Methods: A cluster randomized controlled trial will be conducted in career, full active duty firefighters (n = 345) who will be randomly assigned (by fire station) to 1 of 3 intervention groups - 1) supervised exercise (n = 115), 2) web-based exercise (n = 115), or 3) control (n = 115). Participants in the supervised and web-based exercise groups will perform back and core exercises previously tested in our recent FEMA-funded grant (EMW-2009-FP-00418), twice per week for 12 months while on duty, in addition to their usual physical fitness routine - The supervised group will perform exercise under direct supervision of certified exercise specialists, and the web-based group will utilize a web-based exercise system. The control group will not perform back and core exercises, but will continue their usual physical fitness routine and receive brief education on general exercise and physical activity principles. Outcome measures include low back injury and illness data obtained and cross-checked from various sources, other standard clinical outcome measures for low back pain and disability, and validated physical fitness tests. Anticipated Outcomes: We hypothesize that the supervised and web-based interventions will reduce lost work days related to low back injury and illness by 40% compared with control. Assuming positive results, this study will deliver an evidence-based exercise intervention for low back injury prevention specifically designed for firefighters and assessed in a full-scale randomized controlled trial.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
264

participants targeted

Target at P75+ for not_applicable low-back-pain

Timeline
Completed

Started Mar 2016

Typical duration for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

February 6, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 12, 2015

Completed
1 year until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2018

Completed
Last Updated

July 2, 2018

Status Verified

June 1, 2018

Enrollment Period

2.2 years

First QC Date

February 6, 2015

Last Update Submit

June 29, 2018

Conditions

Keywords

low back painlow back injuryfirefighterpreventionphysical fitnessexercise trainingworksiteweb-based

Outcome Measures

Primary Outcomes (1)

  • Mean number of lost work days per participant over a 12-month period due to work-related injury or illness in the low back region

    12 months

Secondary Outcomes (3)

  • Incidence rate of lost work days due to work-related injury or illness in the low back region

    12 months

  • Time to event of an episode of lost work days due to work-related injury or illness in the low back region

    12 months

  • Number of episodes of lost work days due to work-related injury or illness in the low back region

    12 months

Other Outcomes (18)

  • Onset of low back injury and illness

    Baseline, monthly; upon occurrence

  • Severity of low back injury and illness

    Baseline, monthly; upon occurrence

  • Mechanism of low back injury and illness

    Baseline, monthly; upon occurrence

  • +15 more other outcomes

Study Arms (3)

Control Group

PLACEBO COMPARATOR

Participants in the control arm will complete the placebo comparator intervention.

Other: Placebo Comparator

Supervised Exercise Group

EXPERIMENTAL

Participants in the supervised exercise intervention arm will perform the experimental intervention under direct 1-on-1 supervision of an exercise specialist.

Other: Experimental Intervention

Web-based Exercise Group

EXPERIMENTAL

Participants in the web-based exercise intervention arm will perform the experimental intervention with use of a web-based exercise system for exercise instruction and guidance, and without direct 1-on-1 on-site supervision.

Other: Experimental Intervention

Interventions

Participants will perform the back and core exercises that were tested in our previous firefighter study (Mayer, 2015), in addition to their usual physical fitness routine. All participants at a given fire station will receive the same intervention and all interventions will be completed at the fire station. Participants will perform 2 exercise sessions each week (each time they are on duty) throughout the study's 12-month duration. The back and core exercise program consists of 1 set of 5 exercises - 4 core exercises on a floor mat and 1 back extension exercise on a variable angle Roman chair - which will take approximately 10 minutes to complete for each session (Mayer, 2015).

Supervised Exercise GroupWeb-based Exercise Group

Participants will receive a 45-60 minute, one-time educational session, which will be delivered to delivered by an exercise specialist in a 1-on-1 format while the participant is on-duty at the fire station, in addition to their usual physical fitness routine. Content for the educational session on evidence-based guidelines for exercise, physical fitness, and general physical activity will be derived from the American College of Sports Medicine (ACSM) Position Stand - Quantity and Quality of Exercise for Developing and Maintaining Cardiorespiratory, Musculoskeletal, and Neuromotor Fitness in Apparently Healthy Adults: Guidance for Prescribing Exercise (Garber, 2011).

Control Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 years or older.
  • Full duty, regular service, career firefighter housed at a standard fire station from Hillsborough County Fire Rescue, St. Petersburg Fire \& Rescue, or Tampa Fire Rescue.

You may not qualify if:

  • Current workers' compensation or personal injury case or litigation
  • Research personnel (e.g. firefighter peer fitness trainers).
  • Participant in the exercise intervention group of our previous FEMA-funded study (EMW-2009-FP-00418).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of South Florida

Tampa, Florida, 33612, United States

Location

Related Publications (3)

  • Garber CE, Blissmer B, Deschenes MR, Franklin BA, Lamonte MJ, Lee IM, Nieman DC, Swain DP; American College of Sports Medicine. American College of Sports Medicine position stand. Quantity and quality of exercise for developing and maintaining cardiorespiratory, musculoskeletal, and neuromotor fitness in apparently healthy adults: guidance for prescribing exercise. Med Sci Sports Exerc. 2011 Jul;43(7):1334-59. doi: 10.1249/MSS.0b013e318213fefb.

    PMID: 21694556BACKGROUND
  • Mayer JM, Quillen WS, Verna JL, Chen R, Lunseth P, Dagenais S. Impact of a supervised worksite exercise program on back and core muscular endurance in firefighters. Am J Health Promot. 2015 Jan-Feb;29(3):165-72. doi: 10.4278/ajhp.130228-QUAN-89.

    PMID: 24524384BACKGROUND
  • Dagenais S, Hayflinger DC, Mayer JM. Economic Evaluation of an Extended Telehealth Worksite Exercise Intervention to Reduce Lost Work Time from Low Back Pain in Career Firefighters. J Occup Rehabil. 2021 Jun;31(2):431-443. doi: 10.1007/s10926-020-09933-8. Epub 2021 Jan 4.

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • John M Mayer, DC, PhD

    University of South Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2015

First Posted

February 12, 2015

Study Start

March 1, 2016

Primary Completion

April 30, 2018

Study Completion

April 30, 2018

Last Updated

July 2, 2018

Record last verified: 2018-06

Locations