An interventional study of PUSH and Protein in Hip Fracture, sponsored by University of Maryland, Baltimore. Terminated at 2 sites in United States. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-26.
Sponsored by University of Maryland, Baltimore · Not applicable, Interventional, and Supportive care
Among 133 studies in Hip Fractures with a site in United States — 22 open to participants now, 31 under way, none of them phase 3. Hip Fractures · United States.
Among the 133 studies in Hip Fractures with a site in United States, this one is the 81st largest by enrollment of the 105 interventional ones that give a count, is one of 8 that started in 2018, is one of 62 with no phase, and was the 74th registered.
842 studies on the registry are indexed under Hip Fractures; 165 are open to participants now.
Browse Hip Fractures studies →22 of the 133 studies in Hip Fractures with a site in United States are open now. Recruiting first, the newest first:
NYU Langone Health · Sites in United States
Ages 65+
SI-BONE, Inc. · Sites in United States
Ages 60+
University of Maryland, Baltimore · Sites in United States
Ages 60+
University of Southern California · Sites in United States, Canada, Norway and 2 more countries
Ages 60+
Yale University · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 104 Hip Fractures studies recruiting now, 82 (79%) set no upper age limit and 6 (6%) stop at 75 or younger; 12 take children under 18; 9 take healthy volunteers.
This study: 60 Years and older · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
133 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 4 · Phase 2 18 · Phase 3 10 · Phase 4 15
First in 1980; this study’s year is marked. 8 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 20 is below the median of 86 across 533 interventional studies indexed under Hip Fractures.
Median enrollment 64 across the 105 interventional studies, 160 across the 26 observational. Of the 84 that completed or were terminated, 36 (43%) have results posted.
This tab as a report to print or save as PDF → With an account.
27 of 133 have an industry lead sponsor. The 10 most frequent:
University of Maryland, Baltimore is the lead sponsor of 700 studies on the registry; 132 are open to participants now.
Of its 92 completed or terminated interventional studies of FDA-regulated products, 66 (72%) have results posted.
University of Maryland, Baltimore has 7 studies filed under Hip Fractures — fewer than ten, so there is no comparison to draw.
16 of the studies in Hip Fractures with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06407427Yale UniversityEvaluating the Efficacy of a Mobile Application in Postoperative Rehabilitation | 2026-12 |
| NCT04809714University of Alabama at BirminghamThe Role of Blood Flow Restriction Therapy in Postoperative Elderly Patients With Hip Fracture | 2026-12-13 |
| NCT04113044AO Innovation Translation CenterGo Fit Fast, Recovery Trajectory Using PROMIS®, Linking PROMIS® | 2026-12-31 |
| NCT06024304Paul E. MatuszewskiInterTAN: Integrated Dual Screw Design Improve Biomechanics/Function Following Fixation Surgery | 2027-01-01 |
| NCT04937868University of California, Los AngelesDeveloping a Decision Instrument to Guide Abdominal-pelvic CT Imaging of Blunt Trauma Patients | 2027-01-15 |
Among the 133 studies in Hip Fractures with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Hip fracture is a common problem among older individuals. The goal of current standard of care after hip fracture is to achieve independent, household ambulation 2-3 months after surgery, yet decreased functional ability typically persists well beyond three months and many patients never resume independent ambulation outside the home. Previous research has established that one must be able to walk at least 300 meters (\~330 yards) within 6 minutes to re-establish routine interactions in the community, such as going to the store or to church. In part, this is based on the average distance from handicapped parking spaces into most facilities. Activity and exercise are believed to be of benefit for reducing disability in older adults, yet the majority of older adults does not participate in regular exercise and is not active. This is especially true for older adults following hip fracture after they complete the usual rehabilitation program.
This research study is being done to test a 16-week, multi-part exercise intervention for hip fracture patients that will be supervised by specially trained physical therapists (PTs). The exercise intervention uses a novel machine to provide strength and endurance training in the home. This has been shown in smaller studies to be safe and effective at increasing strength. The purpose of this small pilot study is to test whether adding a protein supplement to the exercise intervention leads to more improvements in a person's ability to walk in their own home and in the local community. With this knowledge, investigators hope to help a greater number of hip fracture patients enjoy a more complete recovery and improved overall health.
In addition to providing important information on adherence, feasibility, and safety, this pilot study of hip fracture patients has the unique advantage of being able to compare data to two recently completed studies where participants received the PUSH intervention without protein supplementation.
A pilot study including 20 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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will be given a whey-based protein supplement containing 27.6g of protein daily for 16 weeks and receive the PUSH intervention. PUSH is a specific multi-component intervention based on improving specific precursors to community ambulation. The intervention addresses endurance with continuous upright exercise for 20 min.; function by improving fast walking, standing from a chair, and stair negotiation; muscle performance by exercising to enhance lower extremity strength; and balance by performing unilateral activities and activities with decreased base of support. Participants receive 32 visits of approximately 60 minutes in duration from a study PT. Participants will receive two visits a week, on non-consecutive days, for 16 weeks. Visits take place in the participant's place of residence. Participants also receive the nutritional intervention for the duration of the 16-week study.
Behavioral: PUSH · Dietary Supplement: Protein · Dietary Supplement: Nutrition
Strength components of the muscle performance intervention are performed using a portable progressive resistive exercise device (Shuttle® MiniPress, Contemporary Design Company, P.O. Box 5089, Glacier, Washington 98244). Muscle performance focuses on bilateral hip extensors, hip abductors, knee extensors, and plantar flexors. Balance and strength are addressed with additional exercises performed while standing. The endurance intervention begins with 2-3 minutes of continuous upper and lower extremity active range of motion (AROM) with the participant sitting in order to increase the participants' heart rate (HR) or exertion closer to the target zone. The participant is then asked to walk on level surfaces and/or up and down steps to keep the HR within the training zone for 20 minutes.
Participants will receive a whey-based protein supplement in the form of a powder containing 27.6g of protein. This dose induces maximum muscle protein synthesis post-exercise. Participants will mix the supplement in 8 oz of water (or other beverage) or soft food (e.g., yogurt, soup) and consume immediately following each exercise session with the study PT. On days when they do not have a physical therapy visit with the study PT, participants will be instructed to take the supplement at the meal time closest to the time of scheduled PT visits to maintain regular daily dosing schedule.
Participants receive 2000 IU vitamin D3, 600 mg calcium, and a multivitamin daily for the duration of the study. Nutritional counseling is also provided. Participants are screened at baseline to assess nutritional risk using the Mini Nutritional Assessment-Short Form and contacted by a registered dietician (RD) within 7 days of baseline testing Those who score ≤7 (malnourished) and participants with baseline serum albumin 2.5-3.5 g/dl receive a visit from an RD with follow-up a week later. Participants who score 8-11 (at risk of malnutrition) and have serum albumin level \>3.5 g/dl receive a phone call from the RD and may receive an in-person visit if warranted. Those screening in the normal range (12-14) and have serum albumin level \>3.5 g/dl receive a phone call from the RD. Weight is monitored every 4 weeks. Those who lose 2% or more body weight receive a call from the RD. Those who lose 5% or more body weight between baseline and follow-up may be referred to an RD.
Distance Walked in Six Minutes
The Six-Minute Walk Test (SMWT) will be used to obtain a continuous measure of total distance walked in six minutes. The SMWT is highly correlated with workloads, heart rate, oxygen saturation, and dyspnea responses when compared to bicycle ergometry and treadmill exercise tests in older persons. It has been performed by elderly, frail and severely compromised participants who cannot perform standard maximal treadmill or cycle ergometry exercise tests.
Time frame: 16 weeks
Cognitive Function (3MS)
The Modified Mini-Mental State (3MS) is a widely used assessment of cognitive status. The 3MS test has a score range of 1-100 with higher scores indicating better cognitive function.
Time frame: 16 weeks
Short Physical Performance Battery (SPPB)
The SPPB evaluates lower extremity performance in older persons based on timed short distance walk, repeated chair stands, and a set of balance tests. Each of the tasks is assigned a score ranging from 0 to 4, with 4 indicating the highest level of performance and 0 an inability to complete the test. A higher score indicates better performance. The scores range from 0-12.
Time frame: 16 weeks
Activities of Daily Living (ADLs)
We will measure ADLs using a modified version of the Pepper Assessment Tool for Disability (PAT-D) with two modifications. First, two items (walking a quarter mile and walking across a small room) were added to address perceived gaps in the original PAT-D scale. This modification is consistent with the version used in the Lifestyle Interventions and Independence for Elders study. Second, two items (walking several blocks and lifting heavy objects) were deleted to avoid duplication with other items in the scale, resulting in a 19-item scale with higher scores indicating worse function. There are 3 subscales: Basic (score range 1-5), instrumental (score range 1-5), and functional (score range 1-5) (formerly mobility subscale).
Time frame: 16 weeks
Quality of Life (SF-36)
We will use an interviewer-administered version of the SF-36 ( 36-Item Short Form Health Survey) , a health survey that assesses quality of life in eight subscales \[physical function, social function, role-physical, role-emotional, bodily pain, mental health, general health, and vitality\]. The SF-36 has been validated as a generic measure of quality of life in many different populations, including patient and non-patient samples. Each of the subscales has a score range of 0-100 and we only used 4 subscales (role-physical, vitality, social functioning, and role-emotional). Higher scores indicate higher quality of life through less disability across the 8 domains.
Time frame: 16 weeks
Nutritional Status
Nutritional status will be assessed using the Mini Nutritional Assessment-Short Form (MNA®-SF), a validated and widely used malnutrition screening tool. We are using a modified version of the MNA®, approved by the scale's developer (the Nestlé company), to facilitate use as an interviewer-administered tool in a research setting. Scores range from 0 to 14; participants scoring ≤7 will be considered malnourished; those scoring 8-11 will be considered to be at risk of malnutrition; and those scoring 12-14 will be considered to have normal nutritional status.
Time frame: 16 weeks
Body Composition- Done Density
Bone density will be estimated using dual-energy x-ray absorptiometry (DXA) (GE LUNAR, Madison, WI). DXA calculates BMD (g.cm2) at the Total Hip and Femoral Neck regions and values are provided in the report produced by the DXA machine.
Time frame: 16 weeks
Muscle Composition
A single computed tomography (CT) scan at the mid-thigh region using a Siemens Somatom Sensation 64 Scanner (Fairfield, CT) was used to assess muscle area, high density lean tissue, and low density lean tissue area (IMAT),all on the fracture and non fracture sides. The CT was analyzed using MIPAV (NIH Image Analysis Visualization Progam, v.7.0).
Time frame: 16 weeks
Power
A Biodex System 3 PRO dynamometer will measure strength per unit of time (power) for bilateral knee flexion-extension. Power is measured in Watts (W). Testing will utilize standardized positioning and joint motion excursions. Subjects performed three repetitions and the values across the three trials were averaged for the power value.
Time frame: 16 weeks
Strength
A Biodex System 3 PRO dynamometer will measure max power over the entire range of motion (strength) for bilateral knee flexion-extension. Strength is measured in Newton-meters (Nm). Testing will utilize standardized positioning and joint motion excursions. Subjects performed three repetitions and the values across the three trials were averaged for the strength value.
Time frame: 16 weeks
Bone Turnover Markers - Bone Formation
Bone formation (serum aminoterminal propeptide of type 1 procollagen; P1NP (ug/l)) will be assessed.
Time frame: 16 weeks
Bone Turnover Markers - Bone Resorption
Bone resorption (serum cross-linked C-telopeptides of type I collagen; CTx-I (ng/mL)) will be assessed.
Time frame: 16 weeks
Hormones
Insulin Growth Factor (IGF-1) will be measured by ELISA.
Time frame: 16 weeks
Inflammatory Cytokines
a) interleukin-6 (IL-6) and b) soluble TNF- α receptor 1 (sTNF- αR1). Both cytokines were measured in serum by ELISA (R\&D Systems Inc., Minneapolis, MN) and expressed at pg/ml levels.
Time frame: 16 weeks
GAITrite Distance
A GAITrite instrumented walkway system will measure spatial and temporal gait parameters. Subjects will walk at their safest fast and natural speeds. Distance (spatial) variables will include step length (cm).Each participant completed two trials of each condition with a short rest period between trials for a total of four trials (i.e., 2 trials × 2 conditions). For each condition, values were averaged over the two trials. Walking aids were permitted only when the participant needed the aid to walk independently.
Time frame: 16 weeks
GAITrite Velocity
A GAITrite instrumented walkway system will measure spatial and temporal gait parameters. Subjects will walk at their safest fast and natural speeds. Time (temporal) variables include walking speed. Each participant completed two trials of each condition with a short rest period between trials for a total of four trials (i.e., 2 trials × 2 conditions). For each condition, values were averaged over the two trials. Walking aids were permitted only when the participant needed the aid to walk independently.
Time frame: 16 weeks
Four-Square Step Test
The Four Square Step Test (FSST) is used to assess dynamic stability and the ability of the subject to step over low objects forward, sideways, and backward. The FSST may be an effective and valid tool for measuring dynamic balance and the subject's fall risk.
Time frame: 16 weeks
Cognitive Function (Trail Making Test (Trails A & B))
The Trail Making Test is a neuropsychological test of visual attention and task switching. It consists of two parts in which the subject is instructed to connect a set of 25 dots as quickly as possible while still maintaining accuracy. The test can provide information about visual search speed, scanning, speed of processing, mental flexibility, as well as executive functioning. It is sensitive to detecting cognitive impairment associated with dementia.
Time frame: 16 weeks
Body Composition- Lean Body Mass
Muscle and lean mass will be estimated using dual-energy x-ray absorptiometry (DXA) (GE LUNAR, Madison, WI). DXA calculates lean muscle mass (kg) from the total body scan and values are provided in the report produced by the DXA machine. The coefficient of variation of these measurements in our previous studies for lean mass was 1.3%.
Time frame: 16 weeks
Muscle Composition-attenuation
A single computed tomography (CT) scan at the mid-thigh region using a Siemens Somatom Sensation 64 Scanner (Fairfield, CT) was used to assess muscle attenuation in Hounsfield units (HU) on the fracture and non fracture sides. The CT was analyzed using MIPAV (NIH Image Analysis Visualization Progam, v.7.0). HUs are used by radiologists to interpret CT images and differentiate between tissues and fluids. Muscle attenuation is a measure of muscle density that correlates with the amount of fat in the muscles. Lower HU values indicate higher levels of intramuscular fat. Therefore, decreased muscle attenuation has been linked to reduced strength and performance. A normal HU for low-density muscle is 0-34.
Time frame: 16 weeks
Adherence With PUSH Intervention
PTs will submit a visit form for each of the 32 visits that records date of visit; start and end time of the visit; reason for missed visit; what activities were performed; and whether activities were performed as prescribed. For the PUSH group, we will also obtain information about the intensity of each activity at initiation of the intervention and every four weeks during the intervention period. Logs completed by PTs will record the detail of each designated activity during intervention sessions as well as any precautions or modifications to activities. Reasons for protocol variations will be noted in the PT log books.
Time frame: 16 weeks
Adherence With Protein Supplement
We will monitor adherence to the protein supplement by weighing the container(s) of protein powder every 4 weeks during the 16-week intervention period to derive an average daily consumption.
Time frame: 16 weeks
Participants were evaluated for eligibility in 3 phases out to 26 weeks post admission in 7 area hospitals (2019-2020). We screened 440 hip fracture patients at Phase 1 and 143 (32%) were eligible based on medical chart review. After Phase 2 and 3 screening, 20 (20%) people were enrolled and screened at Phase 2. Of those who consented, 3 were found to be ineligible at Phase 3, 2 refused, 1 was not able to have baseline testing within timeframe, and 14 participants completed baseline testing
| Milestone | PUSH Plus Protein and Nutrition |
|---|---|
| Started | 14 |
| Completed | 9 |
| Not completed | 5 |
| Withdrew: Death | 1 |
| Withdrew: Withdrawal by subject | 2 |
| Withdrew: Withdraw due to covid-19 shutdown | 2 |
The Six-Minute Walk Test (SMWT) will be used to obtain a continuous measure of total distance walked in six minutes. The SMWT is highly correlated with workloads, heart rate, oxygen saturation, and dyspnea responses when compared to bicycle ergometry and treadmill exercise tests in older persons. It has been performed by elderly, frail and severely compromised participants who cannot perform standard maximal treadmill or cycle ergometry exercise tests.
| meters | PUSH Plus Protein and Nutrition |
|---|---|
| Distance Walked in Six Minutes | 179.84 ± 60.14 |
The Modified Mini-Mental State (3MS) is a widely used assessment of cognitive status. The 3MS test has a score range of 1-100 with higher scores indicating better cognitive function.
| units on a scale | PUSH Plus Protein and Nutrition |
|---|---|
| Cognitive Function (3MS) | 92.78 ± 8.26 |
The SPPB evaluates lower extremity performance in older persons based on timed short distance walk, repeated chair stands, and a set of balance tests. Each of the tasks is assigned a score ranging from 0 to 4, with 4 indicating the highest level of performance and 0 an inability to complete the test. A higher score indicates better performance. The scores range from 0-12.
| units on a scale | PUSH Plus Protein and Nutrition |
|---|---|
| Short Physical Performance Battery (SPPB) | 5.44 ± 2.24 |
We will measure ADLs using a modified version of the Pepper Assessment Tool for Disability (PAT-D) with two modifications. First, two items (walking a quarter mile and walking across a small room) were added to address perceived gaps in the original PAT-D scale. This modification is consistent with the version used in the Lifestyle Interventions and Independence for Elders study. Second, two items (walking several blocks and lifting heavy objects) were deleted to avoid duplication with other items in the scale, resulting in a 19-item scale with higher scores indicating worse function. There are 3 subscales: Basic (score range 1-5), instrumental (score range 1-5), and functional (score range 1-5) (formerly mobility subscale).
| score on a scale | PUSH Plus Protein and Nutrition |
|---|---|
| Basic Subscale | 1.41 ± 0.54 |
| Functional Subscale | 1.98 ± 0.72 |
| Instrumental Subscale | 1.08 ± 0.20 |
We will use an interviewer-administered version of the SF-36 ( 36-Item Short Form Health Survey) , a health survey that assesses quality of life in eight subscales \[physical function, social function, role-physical, role-emotional, bodily pain, mental health, general health, and vitality\]. The SF-36 has been validated as a generic measure of quality of life in many different populations, including patient and non-patient samples. Each of the subscales has a score range of 0-100 and we only used 4 subscales (role-physical, vitality, social functioning, and role-emotional). Higher scores indicate higher quality of life through less disability across the 8 domains.
| score on a scale | PUSH Plus Protein and Nutrition |
|---|---|
| Role Physical | 50.0 ± 41.46 |
| Vitality | 56.67 ± 14.14 |
| Social Functioning | 86.11 ± 22.92 |
| Role Emotional | 74.07 ± 43.39 |
Nutritional status will be assessed using the Mini Nutritional Assessment-Short Form (MNA®-SF), a validated and widely used malnutrition screening tool. We are using a modified version of the MNA®, approved by the scale's developer (the Nestlé company), to facilitate use as an interviewer-administered tool in a research setting. Scores range from 0 to 14; participants scoring ≤7 will be considered malnourished; those scoring 8-11 will be considered to be at risk of malnutrition; and those scoring 12-14 will be considered to have normal nutritional status.
| score on a scale | PUSH Plus Protein and Nutrition |
|---|---|
| Nutritional Status | 12.33 ± 2.29 |
Bone density will be estimated using dual-energy x-ray absorptiometry (DXA) (GE LUNAR, Madison, WI). DXA calculates BMD (g.cm2) at the Total Hip and Femoral Neck regions and values are provided in the report produced by the DXA machine.
| g/cm2 | PUSH Plus Protein and Nutrition |
|---|---|
| Total Hip BMD | .72 ± .10 |
| Femoral neck BMD | .71 ± .09 |
A single computed tomography (CT) scan at the mid-thigh region using a Siemens Somatom Sensation 64 Scanner (Fairfield, CT) was used to assess muscle area, high density lean tissue, and low density lean tissue area (IMAT),all on the fracture and non fracture sides. The CT was analyzed using MIPAV (NIH Image Analysis Visualization Progam, v.7.0).
| cm2 | PUSH Plus Protein and Nutrition |
|---|---|
| High density muscle -fractured side | 46.83 ± 11.90 |
| High density muscle- non fractured side | 55.65 ± 15.43 |
| Low density muscle-fractured side | 26.04 ± 8.45 |
| Low density muscle-non fractured side | 25.73 ± 8.30 |
A Biodex System 3 PRO dynamometer will measure strength per unit of time (power) for bilateral knee flexion-extension. Power is measured in Watts (W). Testing will utilize standardized positioning and joint motion excursions. Subjects performed three repetitions and the values across the three trials were averaged for the power value.
| W | PUSH Plus Protein and Nutrition |
|---|---|
| Knee extension-fracture side | 20.21 ± 7.71 |
| Knee extension-non fracture side | 24.51 ± 8.70 |
| Knee flexion-fracture side | 12.28 ± 2.69 |
| Knee flexion-non fracture side | 15.84 ± 2.52 |
A Biodex System 3 PRO dynamometer will measure max power over the entire range of motion (strength) for bilateral knee flexion-extension. Strength is measured in Newton-meters (Nm). Testing will utilize standardized positioning and joint motion excursions. Subjects performed three repetitions and the values across the three trials were averaged for the strength value.
| Nm | PUSH Plus Protein and Nutrition |
|---|---|
| Knee extension-fracture side | .34 ± .13 |
| Knee extension-non fracture side | .40 ± .14 |
| Knee flexion-fracture side | .21 ± .05 |
| Knee flexion-non fracture side | .27 ± .04 |
Bone formation (serum aminoterminal propeptide of type 1 procollagen; P1NP (ug/l)) will be assessed.
| ug/l | PUSH Plus Protein and Nutrition |
|---|---|
| Bone Turnover Markers - Bone Formation | 86.69 ± 52.02 |
Bone resorption (serum cross-linked C-telopeptides of type I collagen; CTx-I (ng/mL)) will be assessed.
| ng/ml | PUSH Plus Protein and Nutrition |
|---|---|
| Bone Turnover Markers - Bone Resorption | .50 ± .19 |
Insulin Growth Factor (IGF-1) will be measured by ELISA.
| ng/ml | PUSH Plus Protein and Nutrition |
|---|---|
| Hormones | 127.05 ± 31.94 |
a) interleukin-6 (IL-6) and b) soluble TNF- α receptor 1 (sTNF- αR1). Both cytokines were measured in serum by ELISA (R\&D Systems Inc., Minneapolis, MN) and expressed at pg/ml levels.
| pg/mL | PUSH Plus Protein and Nutrition |
|---|---|
| TNF-alpha R1 | 1685.88 ± 510.15 |
| IL-6 | 4.81 ± 2.34 |
A GAITrite instrumented walkway system will measure spatial and temporal gait parameters. Subjects will walk at their safest fast and natural speeds. Distance (spatial) variables will include step length (cm).Each participant completed two trials of each condition with a short rest period between trials for a total of four trials (i.e., 2 trials × 2 conditions). For each condition, values were averaged over the two trials. Walking aids were permitted only when the participant needed the aid to walk independently.
| cm | PUSH Plus Protein and Nutrition |
|---|---|
| Normal Walk distance | 723.11 ± 33.39 |
| Fast Walk distance | 699.39 ± 38.24 |
A GAITrite instrumented walkway system will measure spatial and temporal gait parameters. Subjects will walk at their safest fast and natural speeds. Time (temporal) variables include walking speed. Each participant completed two trials of each condition with a short rest period between trials for a total of four trials (i.e., 2 trials × 2 conditions). For each condition, values were averaged over the two trials. Walking aids were permitted only when the participant needed the aid to walk independently.
| cm/sec | PUSH Plus Protein and Nutrition |
|---|---|
| Normal walk speed | 58.99 ± 13.04 |
| Fast walk speed | 81.01 ± 22.88 |
The Four Square Step Test (FSST) is used to assess dynamic stability and the ability of the subject to step over low objects forward, sideways, and backward. The FSST may be an effective and valid tool for measuring dynamic balance and the subject's fall risk.
| seconds | PUSH Plus Protein and Nutrition |
|---|---|
| Four-Square Step Test | 10.32 ± 14.24 |
The Trail Making Test is a neuropsychological test of visual attention and task switching. It consists of two parts in which the subject is instructed to connect a set of 25 dots as quickly as possible while still maintaining accuracy. The test can provide information about visual search speed, scanning, speed of processing, mental flexibility, as well as executive functioning. It is sensitive to detecting cognitive impairment associated with dementia.
| seconds | PUSH Plus Protein and Nutrition |
|---|---|
| Trails A | 96.33 ± 82.59 |
| Trails B | 185.0 ± 79.09 |
Muscle and lean mass will be estimated using dual-energy x-ray absorptiometry (DXA) (GE LUNAR, Madison, WI). DXA calculates lean muscle mass (kg) from the total body scan and values are provided in the report produced by the DXA machine. The coefficient of variation of these measurements in our previous studies for lean mass was 1.3%.
| kg | PUSH Plus Protein and Nutrition |
|---|---|
| Body Composition- Lean Body Mass | 40.16 ± 57.65 |
PTs will submit a visit form for each of the 32 visits that records date of visit; start and end time of the visit; reason for missed visit; what activities were performed; and whether activities were performed as prescribed. For the PUSH group, we will also obtain information about the intensity of each activity at initiation of the intervention and every four weeks during the intervention period. Logs completed by PTs will record the detail of each designated activity during intervention sessions as well as any precautions or modifications to activities. Reasons for protocol variations will be noted in the PT log books.
| number of visits | PUSH Plus Protein and Nutrition |
|---|---|
| Adherence With PUSH Intervention | 25.33 ± 11.74 |
We will monitor adherence to the protein supplement by weighing the container(s) of protein powder every 4 weeks during the 16-week intervention period to derive an average daily consumption.
| grams per day | PUSH Plus Protein and Nutrition |
|---|---|
| Adherence With Protein Supplement | 26.42 (25.81 to 27.2) |
A single computed tomography (CT) scan at the mid-thigh region using a Siemens Somatom Sensation 64 Scanner (Fairfield, CT) was used to assess muscle attenuation in Hounsfield units (HU) on the fracture and non fracture sides. The CT was analyzed using MIPAV (NIH Image Analysis Visualization Progam, v.7.0). HUs are used by radiologists to interpret CT images and differentiate between tissues and fluids. Muscle attenuation is a measure of muscle density that correlates with the amount of fat in the muscles. Lower HU values indicate higher levels of intramuscular fat. Therefore, decreased muscle attenuation has been linked to reduced strength and performance. A normal HU for low-density muscle is 0-34.
| HU | PUSH Plus Protein and Nutrition |
|---|---|
| Muscle Attenuation (HU)- fracture side | 14.45 ± 8.07 |
| Muscle Attenuation (HU)-non fracture side | 19.85 ± 7.28 |
Collected over The requirements for reporting RAEs began when the participant provided informed consent and ended 30 days after the participant's involvement (up to 16 weeks) in the study was completed.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| PUSH Plus Protein and Nutrition | 1/12 (8.3%) | 2/12 (16.7%) | 0/12 (0%) |
| Event | PUSH Plus Protein and Nutrition |
|---|---|
| PneumoniaInfections and infestations | 1/12 |
| CholecystitisInfections and infestations | 1/12 |
Participants were hip fracture patients 60 years of age and older with surgical repair enrolled within 26 weeks post admission who were living in the community at the time the time of baseline testing.
| Age, Continuous(years) | PUSH Plus Protein and Nutrition |
|---|---|
| Mean | 82.07 ± 7.34 |
| Sex: Female, Male(Participants) | PUSH Plus Protein and Nutrition |
|---|---|
| Female | 10 |
| Male | 4 |
| Ethnicity (NIH/OMB)(Participants) | PUSH Plus Protein and Nutrition |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 14 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | PUSH Plus Protein and Nutrition |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 14 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | PUSH Plus Protein and Nutrition |
|---|---|
| United States | 14 |
| Fracture type(Participants) | PUSH Plus Protein and Nutrition |
|---|---|
| Femoral neck | 4 |
| Pertrochanteric | 10 |
| Comorbidities(number of comorbidities) | PUSH Plus Protein and Nutrition |
|---|---|
| Mean | 5.07 ± 3.54 |
| BMI(kg/m2) | PUSH Plus Protein and Nutrition |
|---|---|
| Mean | 26.2 ± 6.09 |
4 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Jul 2018 to primary completion in Dec 2020, 28 months.
Results were first posted in Nov 2024, 3 years 11 months after primary completion.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Proteins
University of Maryland, Baltimore →