PUSH Plus Protein Pilot for Hip Fracture Patients

A pilot study including 30 older adults who have experienced a hip fracture will be carried
out with participants receiving a specific multi-component intervention with protein
supplementation (PUSH Plus Protein). Study activities for participants meeting eligibility
criteria will take place after post-acute rehabilitation ends, up to 26 weeks after admission
to the hospital for hip fracture. Patients age 60 and older who have had surgical repair for
hip fracture will be identified in study hospitals or by self-referral and evaluated for
eligibility. Following consent to participate, eligible participants will undergo a
comprehensive baseline assessment. Participants completing the entire baseline assessment
will be eligible to receive the intervention. All participants will receive the PUSH Plus
Protein intervention. The follow-up assessment will occur after the intervention is
completed, approximately 16 weeks after baseline testing. The primary endpoint will be
measured using the Six-Minute Walk Test (SMWT).

Participants in this pilot will receive the same specific multi-component 16-week
intervention, PUSH, as participants in the multi-site randomized controlled trial, "Improving
Community Ambulation after Hip Fracture (CAP)" (NCT01783704). The purpose of this study is to
test whether adding a protein supplement to the PUSH intervention (PUSH Plus Protein) leads
to greater improvement in a person's ability to walk in their own home and in the local
community compared to the PUSH intervention alone; therefore, data in this pilot study will
be compared to data from participants in the CAP study across the three sites who received
the PUSH intervention alone (n=105). The working hypothesis is that PUSH Plus Protein will
lead to greater improvements in ability to walk in the community compared to PUSH.

Investigators will also compare the effect of PUSH Plus Protein intervention to PUSH
intervention alone on secondary outcomes in the CAP study believed to be precursors to
community ambulation as shown in Aim 2 below.

Investigators can also compare participants in the pilot study to participants who received
PUSH alone in the ancillary study to CAP, "Mechanistic Pathways to Community Ambulation
(CAP-MP)" (n=19) to examine whether PUSH Plus Protein has an impact on the mechanistic
factors on the pathway to recovery of ambulatory ability after hip fracture (Aim 3).

Aim 1. To test whether PUSH Plus Protein intervention improves community ambulation (as
measured by distance walked in six minutes) compared to PUSH intervention alone (from CAP
parent study) at the end of 16 weeks.

Aim 2. To assess the effects of PUSH Plus Protein on precursors to community ambulation
compared to the PUSH intervention alone (CAP study). To determine the effects of PUSH Plus
Protein intervention, compared to PUSH, on several other outcomes in CAP including activities
of daily living (ADLs), quality of life, lower-extremity physical performance, increase of ≥
50 meters in distance walked in six minutes, cognitive status, and nutritional status.

Aim 3. To determine the effects of PUSH Plus Protein intervention on the mechanistic factors
compared to PUSH intervention alone (CAP-MP ancillary study). To determine if, at the end of
the 16 week intervention, participants in the PUSH Plus Protein intervention, compared to
PUSH alone, have: a) greater muscle volume and attenuation (i.e., reduced intra-muscular fat)
of the thigh; b) greater lower extremity strength; c) better gait parameters; d) greater bone
mineral density and bone strength; e) more bone formation and less bone resorption; and f)
lower levels of circulating inflammatory cytokines.

Aim 4. To determine safety and tolerability of delivering the PUSH Plus Protein intervention
to hip fracture patients. This pilot study will be used to estimate the sample size
requirements for a more definitive study.

Inclusion Criteria:

- Closed fracture of proximal femur

- Age 60 or older at time of baseline testing

- 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 baseline
testing

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
baseline testing

- Not fully weight-bearing on fractured leg or non-fractured leg at time of baseline
testing

- 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 baseline testing

- Severely diminished lower extremity sensation or ulceration

- Uncontrolled hypertension

- Chronic kidney disease

- Severe liver disease (e.g., hepatitis, fatty liver disease, cirrhosis)

- Poorly controlled and/or insulin-dependent diabetes

- Known dairy allergy

- 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

- Baseline testing not done 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