Operational Stress for Fatigue

(REP DEF Trial)

JA
Overseen ByJess 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
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how repeated stress and limited recovery affect muscle protein synthesis, overall body protein balance, iron absorption, and aerobic performance. It involves active adults, categorized by body fat percentage, who will undergo cycles of energy deficit and recovery. Participants should be weight-stable, healthy, and regularly engaged in exercise such as step-ups or aerobic activities for at least six months. As an unphased trial, this study offers participants the chance to contribute to foundational research that could enhance understanding of exercise and recovery.

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 prior data suggests that these operational stressors are safe for active adults?

Research has shown that working long hours can lead to fatigue, which poses dangers, especially in demanding jobs. Fatigue can impair job performance and overall health. Studies suggest that managing fatigue is crucial for safety.

Burnout, often resulting from heavy workloads or insufficient rest, can exacerbate safety and health issues. This study examines the cycle of stress and recovery, mirroring experiences in demanding jobs. Although it does not involve specific medication, understanding stress's impact on the body is vital.

Prospective participants should consider their stress and fatigue management strategies. This research aims to identify better ways to manage these challenges.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how operational stressors impact fatigue differently based on body weight phenotypes. Unlike standard fatigue treatments that typically focus on medications or lifestyle changes to boost energy, this trial examines the body's response to controlled energy deficits and recovery phases. By comparing active adults with overweight and normal weight phenotypes, the trial hopes to uncover how these stressors affect fatigue in diverse body types, potentially leading to more personalized and effective fatigue management strategies in the future.

What evidence suggests that operational stressors could be effective for fatigue?

This trial will compare the effects of operational stress on active adults representing overweight and normal weight phenotypes. Research has shown that work-related stress can impact mental health and task performance. Studies with military personnel found that repeated stress can cause mental fatigue and lower performance. For instance, excessive workload often leads to fatigue, which then affects performance. While direct evidence linking stress to reduced fatigue is limited, stress is known to alter stress levels and performance outcomes. This suggests that understanding and managing work-related stress might help address fatigue-related issues.678910

Who Is on the Research Team?

JA

Jess A Gwin Principal Investigator, PhD

Principal Investigator

United States Army Research Institute of Environmental Medicine

Are You a Good Fit for This Trial?

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
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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
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Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Active adults representative of overweight phenotypeExperimental Treatment1 Intervention
Group II: Active adults representative of normal weight phenotypeActive Control1 Intervention

Find a Clinic Near You

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+

Citations

Evaluation of Before Operational Stress: A Program to ...The current study was designed to assess individual and group changes in several mental health symptoms commonly reported among PSP (i.e., ...
Experience of military psychologists working with service ...This study examines the occupational stressors, emotional distress, and psychological fatigue experienced by military psychologists working with service members
The relationship between organisational stressors and mental ...This study aimed to conduct a systematic review to assess the relationship between organisational stressors and police officer mental wellbeing.
Measuring the Impact of Operational Stress: The Relevance of ...During deployment, the results indicated a small but positive effect that is consistent with previous studies of Swedish peacekeeping troops ...
The Impact of Workload and Fatigue on PerformanceThe results indicated that high workload is a significant predictor of fatigue, and increased subjective fatigue negatively impacted performance across various ...
Influence of Burnout on Patient Safety: Systematic Review ...The presence of burnout among health professionals is associated with worsening patient safety. High levels of burnout is related to external factors.
Work-related fatigue: A hazard for workers experiencing ...Long working hours and fatigue are significant occupational safety and health (OSH) hazards for working populations who experience disproportionate risks of ...
Effects of fatigue on teams and their role in 24/7 operationsFatigue is a significant threat to performance, productivity, safety, and well-being, and strategies for managing fatigue are an important area of research.
Evaluation of Before Operational Stress: A Program to ...The current article introduces the Before Operational Stress (BOS) program, which was designed for delivery early in a PSP career to enhance self-awareness and ...
Workplace Stress - Overview | Occupational Safety and ...Nearly one in five US adults live with a mental illness. Workplace stress has been reported to cause 120,000 deaths in the US each year.
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