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Low Back PainNCT02362243

Worksite Exercise Interventions for Low Back Injury Prevention in Firefighters

A study testing Experimental Intervention in people with Low Back Pain, run by University of South Florida at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Low Back Pain
What is being tested?
Experimental Intervention
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
264 participants
Where
1 siteUnited States
Study dates
Mar 2016to 30 Apr 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of South Florida

    Tampa, Florida, 33612

Other trials in United States

About this study

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.

Read more

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.

Read the 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.

Conditions
Low Back Pain
Being tested
Experimental Intervention, Placebo Comparator
Keywords
low back pain, low back injury, firefighter, prevention, physical fitness, exercise training, worksite, web-based
Medical subject headings
Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Experimental InterventionOther

    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).

  • Placebo ComparatorOther

    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).

Study groups in NCT02362243
Study groupRoleWhat they receive
Control GroupPlacebo comparatorParticipants in the control arm will complete the placebo comparator intervention.
Receives: Other: Placebo Comparator
Supervised Exercise GroupExperimentalParticipants in the supervised exercise intervention arm will perform the experimental intervention under direct 1-on-1 supervision of an exercise specialist.
Receives: Other: Experimental Intervention
Web-based Exercise GroupExperimentalParticipants 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.
Receives: Other: Experimental Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 12 months

Secondary outcomes (3)
  1. Incidence rate of lost work days due to work-related injury or illness in the low back region

    Measured: 12 months

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

    Measured: 12 months

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

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2015 (estimated)
  2. Study startMar 2016
  3. Primary completion30 Apr 2018
  4. Study completion30 Apr 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
264 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02362243
Sponsor's protocol ID
EMW-2013-FP-00723
Status last verified
Jun 2018
First submitted
6 Feb 2015
Last updated
2 Jul 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided: To be determined.

Publications

  • 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.

    PubMed 21694556
  • 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.

    PubMed 24524384
  • 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.

    PubMed 33394268

Questions about this trial

What is this clinical trial studying?

A study testing Experimental Intervention in people with Low Back Pain, run by University of South Florida at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02362243, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2018.

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