search
Back to results

Worksite Exercise Interventions for Low Back Injury Prevention in Firefighters

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Experimental Intervention
Placebo Comparator
Sponsored by
University of South Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Low Back Pain focused on measuring low back pain, low back injury, firefighter, prevention, physical fitness, exercise training, worksite, web-based

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).

Sites / Locations

  • University of South Florida

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Control Group

Supervised Exercise Group

Web-based Exercise Group

Arm Description

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

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
February 6, 2015
Last Updated
June 29, 2018
Sponsor
University of South Florida
Collaborators
Federal Emergency Management Agency
search

1. Study Identification

Unique Protocol Identification Number
NCT02362243
Brief Title
Worksite Exercise Interventions for Low Back Injury Prevention in Firefighters
Official Title
Worksite Exercise Interventions for Low Back Injury Prevention in Firefighters
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
April 30, 2018 (Actual)
Study Completion Date
April 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of South Florida
Collaborators
Federal Emergency Management Agency

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Low back injury is one of the most common and disabling disorders in firefighters (IAFF, 2008). Thus, novel interventions are needed to counteract the adverse consequences of this disorder and its impact on firefighter safety. Our long-term research objective is to develop and test interventions to reduce the incidence, morbidity, economic, and other adverse consequences of low back injury and illness in firefighters. Our previous studies funded by the FEMA Assistance to Firefighters Grant Program demonstrated that: 1) a relationship exists between poor back muscular endurance and increased prevalence of low back pain in firefighters (Verna, 2010); and 2) a worksite intervention including back and core exercise training is safe and effective in improving back and core muscular endurance in firefighters (Mayer, 2015). The purpose of the current study, which builds upon our previous work, is to assess the clinical effectiveness of back and core exercise interventions for low back injury prevention in firefighters. Specific Aims (Purpose) 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. Hypotheses: Primary - The supervised exercise intervention will reduce the number of lost work days related to low back injury and illness over the 12-month intervention period by 40% compared with control. Secondary - The web-based exercise intervention will reduce the number of lost work days related to low back injury and illness over the 12-month intervention period by 40% compared with control. No difference between the supervised and web-based exercise interventions in lost work days will be observed. To test the hypotheses, a 3-arm, cluster randomized controlled trial will be conducted in career, full active duty firefighters from 76 stations of 3 fire rescue departments in the Tampa Bay region of Florida. Firefighters (n = 345) will be randomly assigned (by fire station) to 1 of 3 exercise intervention groups - 1) supervised, (n = 115), 2) web-based (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, in addition to their usual physical fitness routine. All participants at a given fire station will receive the same intervention and interventions will be completed during normal shift hours at the fire station. The supervised group will perform back and core exercises with on-site, 1-on-1, direct supervision by certified exercise specialists (e.g. peer fitness trainers from the partner fire departments) for each exercise session using an identical strategy as our previous study. The web-based group will be provided an interactive web-based delivery, guidance, and monitoring system for back and core exercises using technology developed by our group and partners, along with remote interaction with and guidance from exercise specialists. 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 to test these hypotheses include low back injury and illness data obtained and cross-checked from various sources, including administrative data (primary outcome), such as reports from the fire departments and workers' compensation data, and participant self-reported questionnaires in accordance with departmental, Occupational Safety and Health Administration (OSHA), and fire service standards. Numerous other clinically relevant measures for low back pain injury and illness, comorbidities, risk factors, and prognosis will also be collected and analyzed, such as incidence, frequency, severity, chronicity/duration, physical function, psychological measures (e.g. fear avoidance), back and core muscular endurance, body mass index, Functional Movement Screen, physical activity and exercise measures, and cost-effectiveness. In order to inform implementation efforts throughout the fire service, we will conduct a health economic analysis, such as cost effectiveness, and collect data to gain a better understanding of the context for implementation of the exercise interventions. Potential impact on firefighter health and safety. The proposed study will provide pivotal evidence for dissemination and implementation throughout the fire service. Assuming positive results, this study will deliver an evidence-based exercise intervention for low back injury prevention specifically for firefighters and assessed in a full-scale randomized controlled trial.. The innovative, efficient, and effective exercise intervention will reduce the adverse consequences of low back injury and illness in firefighters, and will be ready for national implementation throughout the fire service for fire departments with similar characteristics as those tested. If successfully implemented, this low back injury prevention program will improve firefighter safety and health in order to enhance resilience and preparedness, so they can more effectively carry out their duties to protect the community. Further, this low back injury prevention program will help improve off-duty and long-term quality of life for firefighters. Unique contribution to body of knowledge. Knowledge gaps exist in evidence-based approaches for low back injury prevention in firefighters, particularly regarding interventions for clinical effectiveness, costs, and implementation. The proposed study will assess such an intervention, and is responsive to 4 health and wellness priorities of the 2011 National Fire Service Research Agenda (NFFF, 2011): 1.0: Health and disease related to firefighter wellness and fitness; 3.0: Implementation / translational research; 7.0: Optimization of performance and reducing risk; and 8.0: Cost effectiveness of health and safety systems.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
low back pain, low back injury, firefighter, prevention, physical fitness, exercise training, worksite, web-based

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
264 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
Participants in the control arm will complete the placebo comparator intervention.
Arm Title
Supervised Exercise Group
Arm Type
Experimental
Arm Description
Participants in the supervised exercise intervention arm will perform the experimental intervention under direct 1-on-1 supervision of an exercise specialist.
Arm Title
Web-based Exercise Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Experimental Intervention
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Placebo Comparator
Intervention Description
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).
Primary Outcome Measure Information:
Title
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
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Incidence rate of lost work days due to work-related injury or illness in the low back region
Time Frame
12 months
Title
Time to event of an episode of lost work days due to work-related injury or illness in the low back region
Time Frame
12 months
Title
Number of episodes of lost work days due to work-related injury or illness in the low back region
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Onset of low back injury and illness
Time Frame
Baseline, monthly; upon occurrence
Title
Severity of low back injury and illness
Time Frame
Baseline, monthly; upon occurrence
Title
Mechanism of low back injury and illness
Time Frame
Baseline, monthly; upon occurrence
Title
Healthcare utilization of low back injury and illness
Time Frame
12 months
Title
Frequency of low back injury and illness
Time Frame
Baseline, monthly; upon occurrence
Title
Current exercise / physical activity habits
Description
International Physical Activity Questionnaire
Time Frame
Baseline, 3/6/9/12 months
Title
Health-related quality of life
Description
SF-12 questionnaire
Time Frame
Baseline, 3/6/9/12 months
Title
Low back disability and physical function
Description
Oswestry Disability Index
Time Frame
Baseline, 3/6/9/12 months
Title
Back beliefs
Description
Back Beliefs Questionnaire
Time Frame
Baseline, 3/6/9/12 months
Title
Back muscular endurance
Description
Modified Biering-Sorensen Isometric Back Endurance Test
Time Frame
Baseline, 12 months
Title
Core muscular endurance
Description
Isometric Prone Plank Test
Time Frame
Baseline, 12 months
Title
Functional movement quality
Description
Functional Movement Screen
Time Frame
Baseline, 12 months
Title
Participation rate
Description
Number of individuals responding to study recruitment, completing initial screening, subsequent screening, enrolling, and providing data at study endpoints
Time Frame
Baseline, 3/6/9/12 months
Title
Adherence to exercise intervention
Description
Rate: percentage of prescribed exercise sessions completed Adherence to exercise progression protocol
Time Frame
3/6/9/12 months
Title
Satisfaction with outcome
Description
Satisfaction with Outcome Questionnaire
Time Frame
12 months
Title
Barriers and facilitators to interventions
Description
Questionnaire
Time Frame
12 months
Title
Cost of intervention
Description
Health economic evaluation using various measures
Time Frame
12 months
Title
Stages of change
Description
Stages of Change Questionnaire
Time Frame
baseline, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John M Mayer, DC, PhD
Organizational Affiliation
University of South Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
To be determined.
Citations:
PubMed Identifier
21694556
Citation
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.
Results Reference
background
PubMed Identifier
24524384
Citation
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.
Results Reference
background
PubMed Identifier
33394268
Citation
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.
Results Reference
derived

Learn more about this trial

Worksite Exercise Interventions for Low Back Injury Prevention in Firefighters

We'll reach out to this number within 24 hrs