PUSH Plus Protein Pilot for Hip Fracture Patients

NCT03410823 | Terminated Results DMC

• 2 other identifiers: HP-00075086R37AG009901
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief 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 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.

Conditions

Hip Fracture

Keywords

hip fracture; exercise; protein

Outcome Measures

Primary Outcomes (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.

  16 weeks

Secondary Outcomes (19)

• Cognitive Function (3MS)

  16 weeks

• Short Physical Performance Battery (SPPB)

  16 weeks

• Activities of Daily Living (ADLs)

  16 weeks

• Quality of Life (SF-36)

  16 weeks

• Nutritional Status

  16 weeks

Other Outcomes (2)

• Adherence With PUSH Intervention

  16 weeks

• Adherence With Protein Supplement

  16 weeks

Study Arms (1)

PUSH Plus Protein and Nutrition

EXPERIMENTAL

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

Interventions

PUSH BEHAVIORAL

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.

PUSH Plus Protein and Nutrition

Protein DIETARY_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.

PUSH Plus Protein and Nutrition

Nutrition DIETARY_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.

PUSH Plus Protein and Nutrition

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• National Institute on Aging (NIA): collaborator

Study Sites (2)

University of Maryland, Baltimore

Baltimore, Maryland, 21201, United States

Location

University of Maryland - St. Joseph Medical Center

Towson, Maryland, 21204, United States

Location

Related Publications (31)

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  BACKGROUND

MeSH Terms

Conditions

Hip Fractures; Motor Activity

Interventions

Proteins; Nutritional Status

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Behavior

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Health Status; Demography; Population Characteristics

Limitations and Caveats

The PUSH + Protein Pilot study was originally powered for 30 participants. However, due to the extended COVID-19 shutdown, the study was terminated early with a smaller sample size of 12 included in the analyses. As a result, we did not analyze all of the secondary outcomes originally planned. Since the pilot study provided important feasibility data for using protein supplement in older hip fracture patients, data analyses were conducted on the primary outcome and a few key secondary outcomes.

Results Point of Contact

• Title: Denise Orwig
• Organization: University of Maryland School of Medicine

dorwig@som.umaryland.edu

410-706-2406

Study Officials

• Jay Magaziner, PhD, MSHyg

  University of Maryland, Baltimore

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 7, 2017
• First Posted: January 25, 2018
• Study Start: July 16, 2018
• Primary Completion: December 12, 2020
• Study Completion: December 12, 2020
• Last Updated: November 26, 2024
• Results First Posted: November 26, 2024

Record last verified: 2024-11

Locations

US (2)