An observational study in Healthy Volunteer, Fatigue and Depression, sponsored by National Institute of Nursing Research (NINR). Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-12-09.
Sponsored by National Institute of Nursing Research (NINR) · Observational
Background:
Objectives:
Eligibility:
Design:
During the first study visit, researchers will conduct the following tests:
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:
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.
1,860 studies on the registry are indexed under Fatigue; 376 are open to participants now.
This study's enrollment of 114 is above the median of 100 across 367 observational studies indexed under Fatigue.
Browse Fatigue studies →National Institute of Nursing Research (NINR) is the lead sponsor of 48 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
To be included, participants must meet the following:
EXCLUSION CRITERIA:
Participants with any one of the following will be excluded:
fatigue score of healthy individuals using standardized questionnaires.
Time frame: study completed
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.
Time frame: study completed
This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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National Institute of Nursing Research (NINR)