Fatigue in Healthy Individuals

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00888563
First received: April 24, 2009
Last updated: March 14, 2014
Last verified: October 2013
  Purpose

Background:

  • People with many different diseases have symptoms of fatigue, which is a general sense of tiredness; however, the causes are not fully understood. Fatigue symptoms may be related to a person s level of fitness, health, and blood chemistries.
  • Researchers are studying the potential role of plasma cytokines (signaling molecules) and hypothalamic-pituitary-adrenal (HPA) axis (part of the neuroendocrine system that controls stress) functioning in symptoms of fatigue.

Objectives:

  • To characterize the symptoms of fatigue in healthy individuals.
  • To collect information on fatigue, pain, depression, stress, sleepiness, and quality of life from healthy adults of all ages.
  • To compare results obtained from people with various illnesses to better understand possible causes of fatigue that are associated with those diseases.

Eligibility:

  • Physically and mentally healthy volunteers18 years of age or older who can speak and read the English language.
  • Exclusion criteria include individuals with a disease or condition causing significant fatigue (congestive heart failure, cancer, or sleep disorders), individuals taking medicines that cause fatigue (beta blockers, diuretics, or narcotics), and individuals who have a major psychiatric condition (major depression, anxiety disorder, or schizophrenia).
  • The following individuals may not participate: those who have two more alcoholic drinks per day, who use illicit drugs, or who drink more than 4 cups of coffee, 8 cups of soda or tea, or similar amounts of other caffeine-containing beverages a day, or eat more than 1 pound of chocolate per day; and individuals who worked evenings or night shifts in the past month.
  • Women who are pregnant or breastfeeding are not eligible.

Design:

  • Participants must make two outpatient visits to the Clinical Center. Each visit will last 5 hours and participants must refrain from smoking and consuming alcohol and caffeine for at least 24 hours.
  • During the first study visit, researchers will conduct the following tests:

    • Psychiatric interview, medical history, pregnancy test, and drug test.
    • Urine test to measure the levels of stress hormones.
    • Questionnaires that measure fatigue, pain, depression, stress, daytime sleepiness, and activity.
    • Physical fitness test, including strength tests, walking tests, and physical activity monitoring.
  • Before the second study visit, patients must refrain from smoking and consuming caffeine and alcohol for at least 24 hours and have nothing, even water, by mouth after midnight. During the second study visit, the following tests will be conducted:

    • Stress hormone test (participant will receive a cortisol-releasing hormone).
    • Four intravenous blood draws to determine cytokine profiles, gene expression, and levels of stress hormones (immune and gentic analysis).
  • Participants will receive a small financial compensation for participation in the study.

Condition
Healthy Volunteer
Fatigue
Depression

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Fatigue in Healthy Individuals

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • The primary outcome of the study is the fatigue score of healthy individuals using standardized questionnaires.

Secondary Outcome Measures:
  • Physical activity, pain, depression, stress, and daytime sleepiness scores; the HPA axis function of healthy individuals; the proinflammatory cytokine profile and gene expression in response to stress.

Estimated Enrollment: 250
Study Start Date: April 2009
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00888563

Contacts
Contact: Leorey N Saligan, C.R.N.P. (301) 451-1685 saliganl@mail.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Leorey N Saligan, C.R.N.P. National Institute of Nursing Research (NINR)
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00888563     History of Changes
Other Study ID Numbers: 090131, 09-NR-0131
Study First Received: April 24, 2009
Last Updated: March 14, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Fatigue
Depression
Healthy Volunteer
HV

Additional relevant MeSH terms:
Depression
Depressive Disorder
Fatigue
Behavioral Symptoms
Mood Disorders
Mental Disorders
Signs and Symptoms

ClinicalTrials.gov processed this record on July 24, 2014