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 @ 8:03 PM
Ignite Modification Date:
2025-12-24 @ 8:03 PM
NCT ID:
NCT01783704
Eligibility Criteria:
Inclusion Criteria:
* Closed fracture of proximal femur
* Age 60 or older at time of randomization
* Minimal trauma fracture
* Non-pathologic fracture
* Surgical fixation of fracture
* Living in the community at time of fracture
* Ambulating without human assistance 2 months prior to fracture
* Unable to walk 300 m or more in 6 minutes without human assistance at time of randomization
Exclusion Criteria:
* Not English speaking
* Does not live within reasonable distance of the clinical center
* End stage renal disease on dialysis
* Recent myocardial infarction
* Uncompensated congestive heart failure
* Lower extremity amputation
* Symptoms of angina pectoris
* Chest pain or shortness of breath (including from severe COPD)
* Participant plans to move out of area or otherwise be unavailable during the 16-week intervention period
* Participation in another clinical trial
* Not community-residing (e.g., resident of a skilled nursing facility) at time of randomization
* Not fully weight-bearing on fractured leg or non-fractured leg at time of randomization
* Calculated creatinine clearance \< 15 ml/min
* Serum albumin \< 2.5 g/dl
* Hemoglobin \< 9 g/dl
* Receiving physical therapy for the hip fracture in the hospital or inpatient rehabilitation facility at time of randomization
* Severely diminished lower extremity sensation or ulceration
* Uncontrolled hypertension
* Denied medical clearance by appropriate medical provider
* Clinical site clinician thinks participant is not a good candidate for study (e.g., not likely to survive study period)
* Cognitive impairment (3MS score \<73)
* Development of chest pain or substantial shortness of breath or ambulating with severe pain during baseline SMWT
* Participant walks less than 4 meters in 40 seconds (\<0.1 m/sec) during baseline SMWT
* Not randomized by 26 weeks post admission for hip fracture
* Final sign-off from study clinician and/or principal investigator is incomplete
* Incomplete baseline data
* Unable to contact participant
* Participant is unable to provide her/his own informed consent
* Participant refuses the study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT01783704
Study Brief:
Protocol Section:
NCT01783704