Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2025-12-25 @ 12:27 AM
NCT ID:
NCT00821067
Eligibility Criteria:
Inclusion Criteria:
* Presents with complaint of fatigue with duration longer than one month
* Males/Females between the ages of 50 and 65 years of age
* No previous clinical diagnosis of pulmonary, cardiac or metabolic disorders based on history
* Capable of performing a sub-maximal incremental treadmill exercise using cardiopulmonary analysis methods
* Normal blood pressure or those with mild, untreated pre-hypertension (\>120/70 or \< 140/90 mmHg)
* Able to be compliant with the supplement regimen, repeat clinical visits and completion of the study questionnaires
* Must be able to understand the consent form, agree to participate, and to execute their signature
Exclusion Criteria:
* Not presently taking any adenine nucleotide enhancing supplements
* History of non-compliance in previous studies
* Known to be pregnant
* Uncontrolled cardiac arrhythmias causing symptoms or unstable hemodynamics
* Moderate to severe gout
* A diagnosis of arthritis of the lower extremities
* Mental impairment, inability to cooperate
* History of acute non-cardiopulmonary disorder that may affect exercise performance, (e.g. infection, renal failure, thyrotoxicosis, etc.)
* Any disorder or condition that in the opinion of the study physician would render exercise unsafe or would impact exercise performance
* Any person who is incarcerated, or on a work release program
Additional Exclusions observed and sequelae during initial baseline evaluation:
* Drop in systolic blood pressure of \>10 mm Hg from baseline despite an increase in workload, when accompanied by other evidence of ischemia
* Moderately severe angina
* Increasing nervous system symptoms (e.g. ataxia, dizziness, or near syncope)
* Signs of poor perfusion (cyanosis or pallor)
* Technical difficulties monitoring the ECG or systolic blood pressure
* Subject's desire to stop
* Sustained ventricular tachycardia
* Electrocardiographic ST elevation (+1.0 mm) in leads without diagnostic Q-waves (other than V1 or aVR)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
65 Years
Study:
NCT00821067
Study Brief:
Protocol Section:
NCT00821067