Operational Stress for Fatigue

(REP DEF Trial)

Overseen By Jess A Gwin Principal Investigator, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: United States Army Research Institute of Environmental Medicine

Must be taking: Oral contraceptives

Must not be taking: Anabolic steroids

Disqualifiers: Musculoskeletal injuries, Cardiovascular disease, Anemia, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

24 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, you must refrain from alcohol, nicotine, caffeine not provided in the study, and dietary supplements during the trial.

What data supports the effectiveness of the treatment Operational Stressors for fatigue?

The research highlights that fatigue in medical staff, particularly nurses, is linked to decreased performance and safety, suggesting that managing operational stressors could improve these outcomes. Effective fatigue management strategies, such as organizational support and improved work schedules, are associated with better recovery and reduced fatigue, indicating potential benefits of addressing operational stressors. ^{1 2 3 4 5}

Is the treatment for operational stress and fatigue safe for humans?

The research articles focus on managing fatigue in various operational settings, such as aviation and transportation, to improve safety and performance. They do not provide specific safety data for a treatment called Operational Stress for Fatigue, but they emphasize the importance of fatigue management to prevent accidents and improve alertness. ^{6 7 8 9 10}

How does the treatment for operational stress-related fatigue differ from other treatments?

The treatment for operational stress-related fatigue is unique because it focuses on managing stress and fatigue in high-demand environments like military operations, using strategies such as alertness management and workload assessment, rather than relying solely on medication. This approach is tailored to the specific challenges of operational settings, emphasizing prevention and management of stress to maintain performance and health. ^{11 12 13 14 15}

What is the purpose of this trial?

This longitudinal study will examine the effects of repeated bouts of operational stress and limited recovery on integrated MPS, whole-body protein balance, iron absorption, and aerobic performance. Following baseline characterization measures, active adults (n=24) representative of normal weight phenotype (NW; n=12) and overweight phenotype (OW; n=12) will complete a 48h balance phase preceding two rounds of repeated 72h energy deficit exposure each immediately followed by a 48h recovery phase. NW cutoff will be defined ≤ 22% body fat for males and ≤ 32% body fat for females. OW cutoff will be defined as \>22% body fat for males and \>32% body fat for females. These body composition cutoffs are informed by the maximum allowable percent body fat standards outlined in current Army Regulation 600-9. Additional details for determining % body fat are outlined in the experimental procedures section of the protocol.

Research Team

Jess A Gwin Principal Investigator, PhD

Principal Investigator

United States Army Research Institute of Environmental Medicine

Eligibility Criteria

This trial is for active adults who are either of normal weight (males ≤ 22% body fat, females ≤ 32%) or overweight (males > 22%, females > 32%), based on Army Regulation standards. Participants will undergo stress tests and have their muscle protein synthesis, iron absorption, and aerobic performance measured.

Inclusion Criteria

Healthy without evidence of chronic illness or musculoskeletal injury as determined by the USARIEM Office of Medical Support and Oversight (OMSO) or home duty station medical support (HMS)

Functional exercise and/or aerobic exercise trained defined by self-report as performing ≥ 2 sessions/wk for previous 6 months

Willing to refrain from alcohol, smoking any nicotine product, vaping, chewing tobacco, caffeine not provided in the study, and dietary supplement use throughout the dietary interventions

Exclusion Criteria

I have injuries that affect my ability to exercise.

History of complications with lidocaine or similar local anesthetic analogue

Claustrophobia or discomfort related to having enclosed equipment around the head

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Balance Phase

Participants undergo a 48-hour balance phase to establish baseline measures

48 hours

Energy Deficit and Recovery Cycle 1

Participants experience a 72-hour energy deficit with increased physical activity and reduced dietary intake, followed by a 48-hour recovery phase

5 days

Energy Deficit and Recovery Cycle 2

Participants undergo a second round of 72-hour energy deficit with increased physical activity and reduced dietary intake, followed by a 48-hour recovery phase

5 days

Follow-up

Participants are monitored for physiological and performance changes after the intervention

4 weeks

Treatment Details

Interventions

• Operational Stressors

Trial Overview The study looks at how repeated operational stress with limited recovery affects the body's ability to synthesize proteins, absorb iron, and perform aerobically. It involves two cycles of a strict regimen: a stressful energy deficit period followed by short recovery.

Participant Groups

Group I: Active adults representative of overweight phenotype Experimental Treatment 1 Intervention

Active adults representative of overweight phenotype will complete a 48h balance phase followed by two rounds of repeated 72h energy deficit exposure, each immediately followed by a 48h recovery phase.

Group II: Active adults representative of normal weight phenotype Active Control 1 Intervention

Active adults representative of normal weight phenotype will complete a 48h balance phase followed by two rounds of repeated 72h energy deficit exposure, each immediately followed by a 48h recovery phase.

Who Is Running the Clinical Trial?

United States Army Research Institute of Environmental Medicine

Lead Sponsor

Trials

67

Recruited

3,700+

Pennington Biomedical Research Center

Collaborator

Trials

314

Recruited

183,000+

References

1. England pubmed.ncbi.nlm.nih.gov

A macroergonomic perspective on fatigue and coping in the hospital nurse work system. [2017]

2. United States pubmed.ncbi.nlm.nih.gov

Factors associated with work-related fatigue and recovery in hospital nurses working 12-hour shifts. [2016]

3. United States pubmed.ncbi.nlm.nih.gov

Correlation of Preflight Risk Assessment Scores With First-Pass Intubation Success in a Critical Care Transport Environment. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Medical staff's emotional exhaustion and its relationship with patient safety dimensions. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Nurse Fatigue and Nurse, Patient Safety, and Organizational Outcomes: A Systematic Review. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Alertness management in aviation operations: enhancing performance and sleep. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Fatigue-Related Aviation Mishaps. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

The Analysis of Occurrences Associated with Air Traffic Volume and Air Traffic Controllers' Alertness for Fatigue Risk Management. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Circadian alertness simulator for fatigue risk assessment in transportation: application to reduce frequency and severity of truck accidents. [2019]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Basic and applied science interactions in fatigue understanding and risk mitigation. [2020]

11. United States pubmed.ncbi.nlm.nih.gov

Alertness management in 24/7 settings: lessons from aviation. [2015]

12. United States pubmed.ncbi.nlm.nih.gov

The Epidemiology of Operation Stress during Continuing Promise 2011: A Humanitarian Response and Disaster Relief Mission aboard a US Navy Hospital Ship. [2018]

13. England pubmed.ncbi.nlm.nih.gov

Understanding fatigue in a naval submarine: Applying biomathematical models and workload measurement in an intensive longitudinal design. [2023]

14. United States pubmed.ncbi.nlm.nih.gov

Combat and Operational Stress Control. [2015]

15. United States pubmed.ncbi.nlm.nih.gov

Consensus recommendations for common data elements for operational stress research and surveillance: report of a federal interagency working group. [2010]