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Assessment of life habits and health status associated with Fatigue

Fatigue Prevention and Management in Mine Workers

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
REBEC
Registry ID
RBR-7gfj5r
Enrollment
Unknown
Registered
2019-11-06
Start date
2019-10-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Occupational Stress, fatigue.

Interventions

In total, 45 shift workers will be followed for 12 months to take dry extract of Rhodiola rosea - RRE (standardized to 2.0 - 4.0% rosavine) 400 mg / day or placebo in the morning. As this is a cross-o
Drug

Sponsors

Universidade Federal de Ouro Preto
Lead Sponsor
Vale S A
Collaborator

Eligibility

Age
18 Years to 18 Years

Inclusion criteria

Inclusion criteria: Workers shortlisted for the high performance operator program according to the company's operational technical criteria will be included in the study

Exclusion criteria

Exclusion criteria: Operators who submit will be excluded: Evidence of substance abuse or dependence in the last 5 years. Non-medical psychiatric treatment at least 4 weeks before study. Clinically significant 24-hour Holter abnormality as complex ventricular arrhythmias, defined as sustained ventricular tachycardia, second-degree mobitz type II or more atrioventricular block, sinus pauses longer than 3 seconds, presence of more than 30 episodes of extrasystoles per hour, and atrial fibrillation or flutter Decompensated metabolic disorders such as diabetes with glycated hemoglobin (HbA1c) greater than 9% and dyslipidemia with LDL greater than 180 mg / dL or triglycerides greater than 500 mg / dL. Degenerative chronic diseases (autoimmune, neoplasia, immunodeficient disease and neurological diseases). Operators with signs and symptoms of infectious diseases. Gastrointestinal disorders with altered absorption. Carriers of moderate to severe sleep disorder Using the following medicines: amitriptyline, clomipramine, imipramine, nortriptyline, fluoxetine, sertraline, paroxetine, venlafaxine, citalopram, lithium carbonate, valproic acid, sodium divalproate, carbamazepine, risperidone, olanzapine, haloperidol, monoaminoxpride inhibitors, moclobemide or selegiline.

Design outcomes

Primary

MeasureTime frame
It is expected to find a decrease in fatigue prevalence after the intervention verified by applying the "Multidimensional Fatigue Inventory 20 (MFI-20)" scale and numerical analog scales (NASs) of chronic fatigue symptoms before and after the experiment.

Secondary

MeasureTime frame
It is expected to find increased quality of life after the intervention verified by applying the "World Health Organization Quality of Life-36 (WHOQOL-bref)" questionnaire before and after the experiment.

Countries

Brazil

Contacts

Public ContactRaimundo do Nascimento Neto

Universidade Federal de Ouro Preto (UFOP)

ufopraimundo@gmail.com+55-31-35591001

Outcome results

None listed

Source: REBEC (via WHO ICTRP)