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 @ 2:44 AM
Ignite Modification Date:
2025-12-25 @ 2:44 AM
NCT ID:
NCT01032733
Eligibility Criteria:
Inclusion Criteria:
* African American or Caucasian Female
* Age between 55 - 79 years
* BMI \> 28 kg/m2
* sedentary lifestyle (defined as \< 20 min/week of aerobic exercise)
* mild to moderate physical impairments (score on the Short Physical
* Performance Battery between 4 - 10).
Exclusion Criteria:
* Weight \>300 lbs.
* Weight loss \> 10 lbs. within the past 6 months
* History of surgery for weight loss
* Hospitalization with the past 6 months
* Significant underlying disease likely to limit lifespan and/or increase risk of interventions (cancer or any condition with a life expectancy \< 5 years with the exception of non-melanoma skin cancer; serious infectious diseases; myocardia infarction, cerebrovascular accident, or unstable angina within the past 6 months; NYHA Class 3 or 4 congestive heart failure; aortic stenosis; chronic hepatitis; cirrhosis; kidney disease; solid organ transplantation; chronic gastrointestinal disorders; fibromyalgia; chronic fatigue syndrome; major psychiatric disorder).
* Metabolic exclusions (resting blood pressure \> 160/90 mmHg, fasting blood glucose \> 160 mg/dl, fasting triglycerides \> 400 mg/dl; patients on medication for hypertension, diabetes, or hyperlipidemia will not be excluded unless their values suggest "poor control").
* Medication exclusions (Antipsychotic agents; monoamine oxidase inhibitors; systemic corticosteroids; antibiotics for HIV or TB; chemotherapeutic drugs; or current use of prescription weight-loss drugs).
* Physical limitations likely to prevent exercise participation (use of walker; breathing problems that limit physical activity).
* Conditions or behaviors likely to affect the conduct of the trial (e.g., unwilling or unable to give informed consent; unwilling to accept random assignment; likely to move out of area within next 2 years; unable to attend weekly meetings; unwilling to complete paperwork; participation in another randomized research project; unwilling or unable to comply with study requirements or schedule)
* Contraindications to MRI (MR-incompatible implants or severe claustrophobia).
* Contraindications to muscle biopsy (i.e., lidocaine allergy)
* Presence of any other medical condition, which in the opinion of the research staff, would be incompatible with participation in the weight loss plus exercise program.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
55 Years
Maximum Age:
79 Years
Study:
NCT01032733
Study Brief:
Protocol Section:
NCT01032733