Status:
COMPLETED
Evaluation and Diagnosis of People With Pain and Fatigue Syndromes
Lead Sponsor:
National Institute of Nursing Research (NINR)
Conditions:
Fatigue
Eligibility:
All Genders
18+ years
Brief Summary
This study will examine people who have pain or fatigue symptoms with a known or unknown diagnosis to determine eligibility for other research studies. No treatment is offered under this protocol. Pe...
Detailed Description
This screening protocol is designed to facilitate patient recruitment to the National Institute of Nursing Research (NINR) clinical research studies on pain and fatigue syndromes. This protocol will a...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- To be included, patients must meet all of the following:
- Are greater than or equal to 18 years of age;
- Have symptoms of pain and/or fatigue.
- EXCLUSION CRITERIA:
- Patients 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.
- In addition to the above criteria, participants with the following conditions will be excluded from the participating in the peak exercise testing:
- 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 and/or affects participants safety during exercise. This includes diseases of the cardiovascular, pulmonary, neurological, metabolic or musculoskeletal systems such as:
- Diagnosis or history of ischemic heart disease
- Dilated or hypertrophic cardiomyopathy
- Non-idiopathic cardiomyopathy
- Uncontrolled hypertension, defined as a resting blood pressure above 140/90 mmHg
- Diagnosis or history of right or left-sided heart failure or pulmonary hypertension
- Diagnosis or history of restrictive or obstructive lung disease
- Diagnosis or history of stroke
- Uncontrolled Type I or Type II Diabetes Mellitus
- Diagnosis of chronic liver disease, chronic kidney disease, acute kidney injury or acute liver failure
- Metastatic cancer active within the previous five years
- Mitochondrial disease
- On medications that would influence aerobic capacity or treadmill performance such as beta-blockers or antiretroviral therapy
- Active substance abuse including ETOH
- Medical or psychological instability such that subjects could not reasonably be expected to fulfill the study requirements
Exclusion
Key Trial Info
Start Date :
May 23 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 17 2020
Estimated Enrollment :
367 Patients enrolled
Trial Details
Trial ID
NCT00677157
Start Date
May 23 2008
End Date
September 17 2020
Last Update
September 22 2020
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892