NCT05287594

Brief Summary

Purpose: To collect and report feasibility data for conducting a future cluster randomized trial to evaluate the efficacy of a TRAINER delivered integrated exercise program in career firefighters, and to determine intervention fidelity and preliminary effects of a TRAINER delivered integrated exercise program in career firefighters. Participants: 52 career firefighters 18 - 60 years old (40 trainees, 6 trainers, 6 administrators). Procedures (methods): Enrolled fire stations will be randomly assigned (3:2 allocation ratio) to a TRAINER or wait-list control (CON) group, stratified by city, using computer-generated random numbers. All enrolled firefighters will undergo a series of assessments at baseline (week 0) and post-testing (week 7) following the TRAINER delivered 6-week intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2023

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 9, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 18, 2022

Completed
1 year until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 26, 2025

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 29, 2025

Completed
Last Updated

December 19, 2025

Status Verified

December 1, 2025

Enrollment Period

2.5 years

First QC Date

March 9, 2022

Last Update Submit

December 12, 2025

Conditions

Keywords

FirefighterTrain-the-TrainerHigh intensity interval trainingNeuromuscular warm-upFire and Rescue Personnel

Outcome Measures

Primary Outcomes (4)

  • Number of Firefighters and Fire Stations Recruited to the Study (Feasibility)

    To demonstrate the feasibility of an integrated exercise program. Feasibility will be defined as recruitment of 40 firefighters and the number of fire stations (out of 26 potential) to the study within 14 months.

    Within 14 months

  • Percentage of Firefighters Retained (Feasibility)

    To demonstrate the feasibility of an integrated exercise program. Retention will be determined from the percentage of firefighters retained at post-testing. Retention of 80% or higher will be considered good feasibility.

    Week 7 (post-intervention)

  • Percentage of Sessions Attended (Feasibility)

    To demonstrate the feasibility of an integrated exercise program. Adherence will be determined from the percentage of sessions attended out of total (12) sessions. Adherence of 80% or higher will be considered good feasibility.

    Week 7 (post-intervention)

  • Qualitative Summaries of Participant Experience in Semi-Structured Interviews (Acceptability)

    Acceptability will be assessed by semi-structured interviews with the firefighters, peer-trainers, and departmental administration (e.g. fire chiefs). Qualitative summaries for intrapersonal, interpersonal, and organizational constructs will be reported.

    Week 7 (post-intervention)

Secondary Outcomes (11)

  • Change in cardiorespiratory fitness as measured by VO2 peak during cycle ergometry

    Baseline (i.e., pre-intervention), 7 weeks (i.e., post-intervention)

  • Change in body composition as measured by % body fat from a 4-compartment model

    Baseline (i.e., pre-intervention), 7 weeks (i.e., post-intervention)

  • Change in explosive muscle strength as measured by dynamometry

    Baseline (i.e., pre-intervention), 7 weeks (i.e., post-intervention)

  • Change in low-back muscular endurance as measured by a modified Biering-Sorensen test

    Baseline (i.e., pre-intervention), 7 weeks (i.e., post-intervention)

  • Change in balance as measured by a modified star excursion balance test

    Baseline (i.e., pre-intervention), 7 weeks (i.e., post-intervention)

  • +6 more secondary outcomes

Study Arms (2)

TRAINER

EXPERIMENTAL

The TRAINER group will receive an integrated exercise program, led by a peer-trainer, including a neuromuscular warm-up and high intensity interval training at their respective fire stations 2 times per week for 6 weeks.

Behavioral: Integrated Exercise Program

Waitlist Control

NO INTERVENTION

The waitlist control group will not receive training during the course of the study, but will be offered the opportunity to receive the integrated exercise program after the study ends.

Interventions

Neuromuscular warm-up: Each participant will perform a series of dynamic stretches, core stability, balance, and medicine ball exercises. The dynamic stretches include 8 repetitions of 6 stretches targeting the hip and thigh musculature, followed by 3 core stability isometric exercises (curl-up, side bridge, and bird dog). Participants will then perform 2 sets (per leg) of hop-to-stabilization (with a reach) balance exercises, followed by 3 separate medicine ball exercises emphasizing explosive full-body movements. High Intensity Interval Training (HIIT): HIIT will include a series of high intensity exercise bouts on a stationary bike that includes a 1:1 work-to-rest ratio. Training intensity will be determined from the peak power output obtained during the baseline VO2 peak assessment and progressively increased by the number of bouts and intensity. The number of work bouts will increase from 5 to 8 bouts and the intensity will increase from 90 to 110% of peak power output.

Also known as: Neuromuscular warm-up, High intensity interval training, HIIT
TRAINER

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Provide informed consent prior to any study procedures are performed
  • Medically cleared for fire suppression duties
  • A career firefighter from a local department (Carrboro, Chapel Hill, and Durham)

You may not qualify if:

  • Highly active firefighters, defined as performing 4 or more days/week of vigorous exercise
  • Pregnancy
  • Recent injury preventing their participation in the exercise routine
  • Involved in an active workers' compensation or personal injury case

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UNC Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Interventions

High-Intensity Interval Training

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Eric Ryan, PhD

    UNC Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two group design where 40 firefighters are cluster randomized (3:2 ratio) into a TRAINER or waitlist control group. There will be 6 trainers who will lead the TRAINER condition. All participants in the TRAINER group and following the intervention in the waitlist control group will receive the same integrated exercise program, led by a peer-trainer, including a neuromuscular warm-up and high intensity interval training at their respective fire stations 2 times per week for 6 weeks.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2022

First Posted

March 18, 2022

Study Start

April 1, 2023

Primary Completion

September 26, 2025

Study Completion

September 29, 2025

Last Updated

December 19, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the University of North Carolina (UNC).

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
9 to 36 months following publication
Access Criteria
Investigator with IRB, IEC, or REB approval and an executed data use agreement with UNC

Locations