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 @ 1:32 PM
Ignite Modification Date:
2025-12-24 @ 1:32 PM
NCT ID:
NCT02628795
Eligibility Criteria:
Inclusion Criteria:
* Between the ages 40 and 80 y.
* Scheduled to undergo elective total hip or knee replacement specifically for the surgical indication of end-stage osteoarthritis.
* First-time hip or knee replacement.
* Capable of providing informed consent (cognitively intact if consenting to surgery).
Exclusion Criteria:
* Any surgical indication other than first-time total joint replacement specifically for end-stage osteoarthritis.
* Bilateral knee/ hip replacement
* History of alcoholism or liver disease.
* Any history of hypo- or hyper-coagulation disorders including subjects taking Coumadin.
* Any individual with end-stage disease and/or a life expectancy less than one year.
* Pregnancy.
* Lactating Women.
* Neurological, musculoskeletal, or other disorder that would preclude them from completing the exercise training intervention and all performance tests.
* Uncontrolled hypertension, unstable or exercise-induced angina pectoris or myocardial ischemia, congestive heart failure.
* Uncontrolled diabetes mellitus.
* Any other condition or events considered exclusionary by the PIs and/or physician Co-Is.
* Lidocaine allergy (1% lidocaine is the local anesthetic used during the muscle biopsy procedure).
* Phenylketonuria (phenylalanine tracer for metabolic studies).
* Currently receiving androgen (e.g., testosterone) or anabolic (e.g., growth hormone (GH), insulin-like growth factor-I (IGF-I)) therapy.
* Body mass index ≥ 35.
* History of lower body progressive resistance training within the past year.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
80 Years
Study:
NCT02628795
Study Brief:
Protocol Section:
NCT02628795