Healthy VolunteerNCT00888563
Fatigue in Healthy Individuals
An observational study of Healthy Volunteer and Fatigue, run by National Institute of Nursing Research (NINR) at 1 site in United States.
Trial 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 person s level of fitness, health, and blood chemistries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Healthy Volunteer, Fatigue, Depression
- How many people
- 114 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Apr 2009to 16 Nov 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be included, participants must meet the following:
- Healthy, 18 years of age or older;
- Speak and understand the English language.
Who cannot join
- 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;
Show all 13Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Healthy Volunteer, Fatigue, Depression
- Keywords
- Fatigue, Depression, Healthy Volunteer, HV
- Medical subject headings
- Fatigue, Depression
What is being measured
The primary outcome is the main question the study is designed to answer.
fatigue score of healthy individuals using standardized questionnaires.
Measured: study completed
Secondary outcomes (1)
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.
Measured: study completed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2009 (estimated)
- Study start23 Apr 2009
- Study completion16 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Nursing Research (NINR)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Leorey N Saligan, C.R.N.P., Principal investigator, National Institute of Nursing Research (NINR)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00888563
- Sponsor's protocol ID
- 090131
- Other IDs
- 09-NR-0131
- Status last verified
- 16 Nov 2017
- First submitted
- 24 Apr 2009
- Last updated
- 9 Dec 2019
- Results posted
- No
Publications
Levy M. Cancer fatigue: a review for psychiatrists. Gen Hosp Psychiatry. 2008 May-Jun;30(3):233-44. doi: 10.1016/j.genhosppsych.2008.01.004.
PubMed 18433655Krupp LB, Pollina DA. Mechanisms and management of fatigue in progressive neurological disorders. Curr Opin Neurol. 1996 Dec;9(6):456-60. doi: 10.1097/00019052-199612000-00011.
PubMed 9007405Brola W, Ziomek M, Czernicki J. [Fatigue syndrome in chronic neurological disorders]. Neurol Neurochir Pol. 2007 Jul-Aug;41(4):340-9. Polish.
PubMed 17874343Flynn S, Leete J, Shahim P, Pattinson C, Guedes VA, Lai C, Devoto C, Qu BX, Greer K, Moore B, van der Merwe A, Ekanayake V, Gill J, Chan L. Extracellular vesicle concentrations of glial fibrillary acidic protein and neurofilament light measured 1 year after traumatic brain injury. Sci Rep. 2021 Feb 16;11(1):3896. doi: 10.1038/s41598-021-82875-0.
PubMed 33594224Lukkahatai N, Walitt B, Espina A, Gelio A, Saligan LN. Understanding the Association of Fatigue With Other Symptoms of Fibromyalgia: Development of a Cluster Model. Arthritis Care Res (Hoboken). 2016 Jan;68(1):99-107. doi: 10.1002/acr.22626.
PubMed 26017904
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fatigue in Healthy Individuals
- ClinicalTrials.gov ID
- NCT00888563
- Acronym / sponsor ID
- 090131
- Conditions
- Healthy Volunteer, Fatigue, Depression
- Keywords
- Fatigue, Depression, Healthy Volunteer, HV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- National Institute of Nursing Research (NINR)US National Institutes of Health
- Study start
- 23 Apr 2009
- Study completion
- 16 Nov 2017
- First posted
- 27 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy, 18 years of age or older;
- Speak and understand the English language.
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
fatigue score of healthy individuals using standardized questionnaires.
Time frame: study completed
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2019.
- Background: PubMed 18433655Levy M. Cancer fatigue: a review for psychiatrists. Gen Hosp Psychiatry. 2008 May-Jun;30(3):233-44. doi: 10.1016/j.genhosppsych.2008.01.004.
- Background: PubMed 9007405Krupp LB, Pollina DA. Mechanisms and management of fatigue in progressive neurological disorders. Curr Opin Neurol. 1996 Dec;9(6):456-60. doi: 10.1097/00019052-199612000-00011.
- Background: PubMed 17874343Brola W, Ziomek M, Czernicki J. [Fatigue syndrome in chronic neurological disorders]. Neurol Neurochir Pol. 2007 Jul-Aug;41(4):340-9. Polish.
- Derived from this study: PubMed 33594224Flynn S, Leete J, Shahim P, Pattinson C, Guedes VA, Lai C, Devoto C, Qu BX, Greer K, Moore B, van der Merwe A, Ekanayake V, Gill J, Chan L. Extracellular vesicle concentrations of glial fibrillary acidic protein and neurofilament light measured 1 year after traumatic brain injury. Sci Rep. 2021 Feb 16;11(1):3896. doi: 10.1038/s41598-021-82875-0.
- Derived from this study: PubMed 26017904Lukkahatai N, Walitt B, Espina A, Gelio A, Saligan LN. Understanding the Association of Fatigue With Other Symptoms of Fibromyalgia: Development of a Cluster Model. Arthritis Care Res (Hoboken). 2016 Jan;68(1):99-107. doi: 10.1002/acr.22626.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leorey N Saligan, C.R.N.P. principal investigator
National Institute of Nursing Research (NINR)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Volunteer and Fatigue, run by National Institute of Nursing Research (NINR) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fatigue score of healthy individuals using standardized questionnaires. (time frame: study completed). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00888563, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2019.