Protocol Number: 09-NR-0131

Title:

Fatigue in Healthy Individuals

Number:

09-NR-0131

Summary:

This protocol is designed to characterize the symptoms of fatigue in healthy individuals using standardized questionnaires and determine if physical activity, pain, depression, 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, perceived stress, daytime sleepiness, and physical activity. Participants will also perform strength testing (e.g. hand grips), walk testing (6-minute walk test), 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.

Sponsoring Institute:

National Institute of Nursing Research (NINR)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): None

Eligibility 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 everyday and with detectable blood alcohol content (BAC) using breath analyzer (greater than 1 mg/dL of BAC);

-Pregnant and lactating women.

Special Instructions:

Currently Not Provided

Keywords:

Fatigue

Depression

Healthy Volunteer

Recruitment Keyword(s):

None

Condition(s):

Healthy Volunteer

Fatigue

Depression

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

None

Supporting Site:

National Institutes of Nursing Research

Contact(s):

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):

Levy M. Cancer fatigue: a review for psychiatrists. Gen Hosp Psychiatry. 2008 May-Jun;30(3):233-44.

Krupp LB, Pollina DA. Mechanisms and management of fatigue in progressive neurological disorders. Curr Opin Neurol. 1996 Dec;9(6):456-60.

Brola W, Ziomek M, Czernicki J. [Fatigue syndrome in chronic neurological disorders]. Neurol Neurochir Pol. 2007 Jul-Aug;4 (4):340-9.

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Clinical Research Informatics, CC.

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