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Hip FractureNCT03410823

PUSH Plus Protein Pilot for Hip Fracture Patients

A study testing PUSH, Protein and Nutrition in people with Hip Fracture, run by University of Maryland, Baltimore at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for
Hip Fracture
What is being tested?
PUSH, Protein and Nutrition
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
2 sitesUnited States
Study dates
16 Jul 2018to 12 Dec 2020
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 33Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • University of Maryland, Baltimore

    Baltimore, Maryland, 21201

  • University of Maryland - St. Joseph Medical Center

    Towson, Maryland, 21204

Other trials in United States

About this study

Official title: Community Ambulation Project (CAP) Ancillary Study - PUSH Plus Protein Pilot Study

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.

Read the detailed description

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.

Conditions
Hip Fracture
Being tested
PUSH, Protein, Nutrition
Keywords
hip fracture, exercise, protein
Medical subject headings
Hip Fractures, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PUSHBehavioural

    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.

  • ProteinDietary supplement

    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.

  • NutritionDietary supplement

    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.

Study groups in NCT03410823
Study groupRoleWhat they receive
PUSH Plus Protein and NutritionExperimentalParticipants 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.
Receives: Behavioral: PUSH; Dietary Supplement: Protein; Dietary Supplement: Nutrition

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 16 weeks

Secondary outcomes (19)

  1. 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.

    Measured: 16 weeks

  2. 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.

    Measured: 16 weeks

  3. 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).

    Measured: 16 weeks

  4. 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.

    Measured: 16 weeks

  5. 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.

    Measured: 16 weeks

  6. 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.

    Measured: 16 weeks

  7. 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).

    Measured: 16 weeks

  8. 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.

    Measured: 16 weeks

  9. 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.

    Measured: 16 weeks

  10. Bone Turnover Markers - Bone Formation

    Bone formation (serum aminoterminal propeptide of type 1 procollagen; P1NP (ug/l)) will be assessed.

    Measured: 16 weeks

  11. Bone Turnover Markers - Bone Resorption

    Bone resorption (serum cross-linked C-telopeptides of type I collagen; CTx-I (ng/mL)) will be assessed.

    Measured: 16 weeks

  12. Hormones

    Insulin Growth Factor (IGF-1) will be measured by ELISA.

    Measured: 16 weeks

  13. Inflammatory Cytokines

    1. 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.

    Measured: 16 weeks

  14. 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.

    Measured: 16 weeks

  15. 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.

    Measured: 16 weeks

  16. 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.

    Measured: 16 weeks

  17. 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.

    Measured: 16 weeks

  18. 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%.

    Measured: 16 weeks

  19. 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.

    Measured: 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jan 2018
  2. Study start16 Jul 2018
  3. Primary completion12 Dec 2020
  4. Study completion12 Dec 2020

Why it stopped: Due to the extended COVID-19 shutdown, the study was terminated early with a smaller sample size of 12 included in the analyses

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03410823
Sponsor's protocol ID
HP-00075086
Other IDs
R37AG009901
Status last verified
Nov 2024
First submitted
7 Dec 2017
Last updated
26 Nov 2024
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Sallinen J, Pakarinen A, Fogelholm M, Alen M, Volek JS, Kraemer WJ, Hakkinen K. Dietary intake, serum hormones, muscle mass and strength during strength training in 49 - 73-year-old men. Int J Sports Med. 2007 Dec;28(12):1070-6. doi: 10.1055/s-2007-965003. Epub 2007 May 11.

    PubMed 17497592

  • Sallinen J, Pakarinen A, Fogelholm M, Sillanpaa E, Alen M, Volek JS, Kraemer WJ, Hakkinen K. Serum basal hormone concentrations and muscle mass in aging women: effects of strength training and diet. Int J Sport Nutr Exerc Metab. 2006 Jun;16(3):316-31. doi: 10.1123/ijsnem.16.3.316.

    PubMed 16948487

  • Chesley A, MacDougall JD, Tarnopolsky MA, Atkinson SA, Smith K. Changes in human muscle protein synthesis after resistance exercise. J Appl Physiol (1985). 1992 Oct;73(4):1383-8. doi: 10.1152/jappl.1992.73.4.1383.

    PubMed 1280254

  • Phillips SM, Tipton KD, Aarsland A, Wolf SE, Wolfe RR. Mixed muscle protein synthesis and breakdown after resistance exercise in humans. Am J Physiol. 1997 Jul;273(1 Pt 1):E99-107. doi: 10.1152/ajpendo.1997.273.1.E99.

    PubMed 9252485

  • Wolfe RR. Skeletal muscle protein metabolism and resistance exercise. J Nutr. 2006 Feb;136(2):525S-528S. doi: 10.1093/jn/136.2.525S.

    PubMed 16424140

  • Borsheim E, Tipton KD, Wolf SE, Wolfe RR. Essential amino acids and muscle protein recovery from resistance exercise. Am J Physiol Endocrinol Metab. 2002 Oct;283(4):E648-57. doi: 10.1152/ajpendo.00466.2001.

    PubMed 12217881

  • Rasmussen BB, Tipton KD, Miller SL, Wolf SE, Wolfe RR. An oral essential amino acid-carbohydrate supplement enhances muscle protein anabolism after resistance exercise. J Appl Physiol (1985). 2000 Feb;88(2):386-92. doi: 10.1152/jappl.2000.88.2.386.

    PubMed 10658002

  • Esmarck B, Andersen JL, Olsen S, Richter EA, Mizuno M, Kjaer M. Timing of postexercise protein intake is important for muscle hypertrophy with resistance training in elderly humans. J Physiol. 2001 Aug 15;535(Pt 1):301-11. doi: 10.1111/j.1469-7793.2001.00301.x.

    PubMed 11507179

  • Norton LE, Layman DK. Leucine regulates translation initiation of protein synthesis in skeletal muscle after exercise. J Nutr. 2006 Feb;136(2):533S-537S. doi: 10.1093/jn/136.2.533S.

    PubMed 16424142

  • Jackman SR, Witard OC, Jeukendrup AE, Tipton KD. Branched-chain amino acid ingestion can ameliorate soreness from eccentric exercise. Med Sci Sports Exerc. 2010 May;42(5):962-70. doi: 10.1249/MSS.0b013e3181c1b798.

    PubMed 19997002

  • Matsumoto K, Koba T, Hamada K, Sakurai M, Higuchi T, Miyata H. Branched-chain amino acid supplementation attenuates muscle soreness, muscle damage and inflammation during an intensive training program. J Sports Med Phys Fitness. 2009 Dec;49(4):424-31.

    PubMed 20087302

  • Verdijk LB, Jonkers RA, Gleeson BG, Beelen M, Meijer K, Savelberg HH, Wodzig WK, Dendale P, van Loon LJ. Protein supplementation before and after exercise does not further augment skeletal muscle hypertrophy after resistance training in elderly men. Am J Clin Nutr. 2009 Feb;89(2):608-16. doi: 10.3945/ajcn.2008.26626. Epub 2008 Dec 23.

    PubMed 19106243

  • Campbell WW, Leidy HJ. Dietary protein and resistance training effects on muscle and body composition in older persons. J Am Coll Nutr. 2007 Dec;26(6):696S-703S. doi: 10.1080/07315724.2007.10719650.

    PubMed 18187436

  • Ponzer S, Tidermark J, Brismar K, Soderqvist A, Cederholm T. Nutritional status, insulin-like growth factor-1 and quality of life in elderly women with hip fractures. Clin Nutr. 1999 Aug;18(4):241-6. doi: 10.1016/s0261-5614(99)80076-4.

    PubMed 10578024

  • Lumbers M, New SA, Gibson S, Murphy MC. Nutritional status in elderly female hip fracture patients: comparison with an age-matched home living group attending day centres. Br J Nutr. 2001 Jun;85(6):733-40. doi: 10.1079/bjn2001350.

    PubMed 11430778

Questions about this trial

What is this clinical trial studying?

A study testing PUSH, Protein and Nutrition in people with Hip Fracture, run by University of Maryland, Baltimore at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 26 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Distance Walked in Six Minutes (time frame: 16 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03410823, which also lists 31 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2024; AzTrials last refreshed its copy on 31 Oct 2026.

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