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Fatigue in Healthy Individuals


N/A
18 Years
N/A
Open (Enrolling)
Both
Healthy Volunteer, Fatigue, Depression

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Trial Information

Fatigue in Healthy Individuals


This protocol is designed to characterize the symptoms of fatigue in healthy individuals
using standardized questionnaires and determine if physical activity, pain, depression,
fatigue

catastrophizing, stress, and daytime sleepiness play a role in the experience. This study
will also examine the potential role of plasma cytokines and hypothalamic-pituitary-adrenal
axis (HPA) functioning in symptoms of fatigue in healthy individuals.

Eligible participants will complete questionnaires that measure fatigue, pain, depression,
fatigue catastrophizing, perceived stress, daytime sleepiness, neurological health, and
physical activity. Participants will also perform strength testing (e.g. hand grips), walk
testing (6-minute walk test), exercise testing on a treadmill, and physical activity
monitoring using a portable activity device. Blood samples will be obtained to determine
cytokine profiles, gene expression, and levels of stress hormones (cortisol,
dehydroepiandrosterone [DHEA], catecholamines). Urine samples will also be obtained to
measure the levels of stress hormones excreted. Information collected in this protocol will
be used to make comparison in subjects who experience extreme symptoms of fatigue due to
many different disorders, in order to better understand the mechanisms of fatigue.

Inclusion Criteria


- INCLUSION CRITERIA:

To be included, participants must meet the following:

- Healthy, 18 years of age or older;

- Speak and understand the English language.

EXCLUSION CRITERIA:

Participants with any one of the following will be excluded:

- Inability to provide informed consent for the study;

- Are unwilling or unable to cooperate with the study procedures or travel to NIH for
the procedures;

- Have a confirmed medical condition causing clinically significant fatigue symptom
(e.g. congestive heart failure, cancer actively receiving therapy, sleep disorders);

- Currently taking medications that cause fatigue (e.g. diuretics, beta blockers,
narcotics);

- Working late evening and night shifts within the past month;

- Have severe psychiatric conditions (e.g. major depressive disorder, bipolar disorder,
anxiety disorder, schizophrenia, drug and/or addiction abuse or dependence);

- Report consuming more than 300mg of caffeine containing beverages (approximately 4
cups of coffee or 8 cups of soda or tea) or food (approximately 1 lb of chocolate)
within 24 hours;

- Reports consuming more than 2 servings of alcohol containing beverages every day and
with detectable blood alcohol content (BAC) using breath analyzer (greater than 1
mg/dL of BAC);

- Pregnant or lactating women.

- Unable to refrain from smoking at least 4 hours prior to exercise testing sessions

- Any medical condition that limits exercise performance (e.g. any condition with a
ventilatory limitation during maximal exercise)

- Any medical condition that affects participants' safety with exercise (e.g.: severe
heart disease, uncontrolled diabetes)

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Outcome Measure:

The primary outcome of the study is the fatigue score of healthy individuals using standardized questionnaires.

Principal Investigator

Leorey N Saligan, C.R.N.P.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Institute of Nursing Research (NINR)

Authority:

United States: Federal Government

Study ID:

090131

NCT ID:

NCT00888563

Start Date:

April 2009

Completion Date:

Related Keywords:

  • Healthy Volunteer
  • Fatigue
  • Depression
  • Fatigue
  • Depression
  • Healthy Volunteer
  • HV
  • Depression
  • Depressive Disorder
  • Fatigue

Name

Location

National Institutes of Health Clinical Center, 9000 Rockville PikeBethesda, Maryland  20892