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:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2025-12-24 @ 7:12 PM
NCT ID:
NCT01687803
Eligibility Criteria:
Inclusion Criteria:
* Body Mass Index: 18.5 to 29.9 kg/m2
* Peri-menopause, as determined by self-report of menstrual history and symptoms for previous 12 months
* Sedentary lifestyle
Exclusion Criteria:
* Individuals who are already physically active
* Pregnant or nursing within the last 6 months
* Plan to become pregnant during the study
* Musculoskeletal disease or disorder which is expected to limit participation in physical activity
* Orthopedic injuries
* Inflammatory arthritis or autoimmune disorders
* Neuromuscular disorders including multiple sclerosis, amyotrophic lateral sclerosis, Parkinson's disease
* Menopause confirmed
* Use of tobacco products
* Family history of premature cardiovascular disease as defined by the ACSM guidelines
* Cardiovascular including a history of cardiac arrest; coronary heart disease, complex ventricular arrhythmia or atrial arrhythmia at rest or with exercise, congestive heart failure, cardiomyopathy, hemodynamically significant valvular heart disease, left bundle block, cardiac pacemaker; implanted cardiac defibrillator; history of aortic aneurysm of at least 7 cm in diameter or aortic aneurysm repair; resting heart rate \< 45 beats per minute or \> 100 beats per minute
* Chronic lung disease resulting in dyspnea at rest or with minimal exertion, lung disease resulting in hypoxia or hypercapnia at rest or with exercise, pulmonary embolus within 6 months, active tuberculosis
* Presence of risk factors for cardiovascular or metabolic disease:
* Hypertension (SBP ≥140 mm Hg and/or DBP ≥ 90 mm Hg); hypertension treated by beta adrenergic blockers regardless of blood pressure
* Elevated fasting LDL cholesterol (≥160 mg/dL)
* Elevated fasting triglycerides (≥300 mg/dL)
* Diagnosed diabetes mellitus or elevated fasting glucose (≥126 mg/dL), adrenal disease, acromegaly, or thyroid disease requiring medication change or other treatment within the previous 3 months
* Weight change greater than 10 lbs in the preceding 6 months
* Medications: chronic corticosteroid use or need for oral corticosteroids more than twice in the last 12 months, antipsychotic medications, beta adrenergic blockers, medications for weight loss (including sibutramine, orlistat, phentermine, phendimetrazine, topiramate, zonisamide), immunosuppressants, amphetamines and other stimulants, and other medications known to influence body weight
* Travel plans that do not permit full participation
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
42 Years
Maximum Age:
52 Years
Study:
NCT01687803
Study Brief:
Protocol Section:
NCT01687803