Status:
COMPLETED
Fatigue in Healthy Individuals
Lead Sponsor:
National Institute of Nursing Research (NINR)
Conditions:
Healthy Volunteer
Fatigue
Eligibility:
All Genders
18+ years
Brief Summary
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 p...
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 catastrophizin...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
April 23 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 16 2017
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT00888563
Start Date
April 23 2009
End Date
November 16 2017
Last Update
December 9 2019
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892