The Role of Blood Flow Restriction Therapy in Postoperative Elderly Patients With Hip Fracture

The Role of Blood Flow Restriction Therapy in the Postop Rehabilitation of Elderly Patients With Hip Fractures: A Randomized Controlled Pilot Study

The investigators aim to study the use of blood flow restriction therapy (BFR) to augment routine post-operative physical therapy in elderly patients (age >= 65) after recovering from surgical treatment of hip fractures.

Study Overview

• Status: Active, not recruiting
• Conditions: Hip Fractures; Muscle Atrophy
• Intervention / Treatment: Other: Routine Post-operative Physical Therapy; Device: Blood Flow Restriction with Delfi Tourniquet System Cuff

Detailed Description

For elderly patients, a hip fracture is a life-altering event associated with poor overall outcomes despite early surgical treatment. The elderly population and those with significant osteopenia is growing exponentially and thus the optimal treatment and rehabilitation of hip fractures warrants increased investigation. Despite numerous interventions, falls plague the elderly population and hip fractures remain a very common problem for this population that needs to be addressed. Rapid deconditioning plays a significant role in patient morbidity following hip surgery. Recently, blood flow restriction (BFR) treatment has been shown to be effective in improving muscle strength when combined with low load resistance training physical therapy programs in elderly patients. Few studies have examined BFR in post-operative orthopedic trauma patients. The investigators aim to study the use of BFR to augment post-operative physical therapy in elderly patients (age >= 65) in the first 2-weeks after recovering from surgical treatment of hip fractures. Due to the profound muscle atrophy that occurs in the immediate postoperative period because of immobility and disuse, the investigators hypothesize that BFR may provide an anabolic effect and conserve muscle strength. The investigators hypothesis was inspired by the findings of the Nobel Prize in Physiology 2019 which describes how varying levels of oxygen shape both physiology and pathology. This is a prospective, randomized blinded 2-week study of elderly patients recovering from surgical treatment of hip fractures with two arms: 1) routine post-op physical therapy 2) routine physical therapy + BFR and neuromuscular electrical stimulation (NMES) beginning on postoperative day 1 and occurring 5 days per week for 2 weeks. To optimize safety, the study will be in an inpatient-only setting and supervised by team members certified in the application of BFR. The investigators plan to apply lessons learned to a larger 8-week intervention upon completion of this short-term pilot study. To our knowledge, this is the first study to use BFR in postoperative geriatric patients. Main outcomes will include thigh leg circumference on postoperative day 1 and at the end of week 2, adverse event log for complications, knee extension strength via handheld dynamometry (HHD) at post-op day 1 and week 2, gait speed, functional tests including timed up and go, opioid MME (morphine milligram equivalent) consumption and patient perceived pain and quality of life measures. The investigators anticipate BFR therapy will be tolerated well, improve global patient health and satisfaction, lead to lower extremity muscle hypertrophy, and enhance functional recovery after geriatric hip fracture carrying tremendous potential for extramural funding and scientific advancement.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Clay A Spitler, MD; Phone Number: 770-309-5377; Email: caspitler@uabmc.edu
• Study Contact Backup: Name: Matthew C Hess, MD; Phone Number: 706-288-4070; Email: mhess@uabmc.edu

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35223
      • University of Alabama at Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 63 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age >= 65 years old, any sex, any ethnicity
• Isolated, closed proximal femur fracture without any prior surgery or orthopedic implants to affected proximal femur. This includes all fractures with primary fracture line that is proximal to the lesser trochanter. For example, subtrochanteric femur fractures are excluded whereas reverse obliquity intertrochanteric femur fractures may be included.
• OTA codes 31A, 31B, and 31C
• Segmental and pathologic femur fractures are excluded.
• Ambulatory without assistive device prior to injury
• Community living prior to injury
• No injury or surgery to the contralateral lower extremity within past 1 year
• Alert and oriented and able to provide informed consent for self
• English speaking
• Able to weight bear as tolerated after surgery as deemed by treating orthopedic surgeon
• Able to tolerate light exercise (could walk approximately 0.5 mile without significant pain or shortness of breath) preoperatively as determined by patient self-reported history

Exclusion Criteria:

• Presence of other significant injuries at the time of injury to the proximal femur that would require additional surgery
• Significant delay in presentation to health care facility (>3 days from time of injury) for assessment and treatment of the proximal femur fracture
• History of DVT in any extremity, existing DVT in any extremity, or any condition known to increase risk for coagulopathy including but not exclusively current pregnancy, current diagnosis of cancer/cancer that is being treated
• Current use of any medication or supplement that may increase blood clotting risk
• History of: sickle cell anemia, peripheral arterial disease, dementia, actively treated cancer
• Varicose veins in either lower extremity
• Any significant medical condition that would preclude ability to bear weight as tolerated postoperatively
• Significant cardiac disease as defined by recent stent placement in the past year or presence of implantable pacemaker device
• Morbid obesity (BMI >40)
• Prior surgery to either lower extremity within one year
• Prior surgery or injury to either lower extremity that would preclude application of a tourniquet and includes but not exclusively: skin grafting, vascular bypass grafting, dialysis site, chronic wound, lymphotomies, varicose vein surgery, presence of tumor)
• Soft tissue injury to either lower extremity that precludes placement of tourniquet
• Diagnosis of uncontrolled hypertension (BP greater than 180/110 on at least two measurements as measured during inpatient stay before surgery)
• Patients with potentially severe problems with maintaining follow-up (ex. Patients who are prisoners, homeless at time of injury, severe dementia, intellectually challenged without adequate family support or have documented significant psychiatric disorder)
• COVID-19 positive
• Admission to ICU postoperatively
• Inadequate postop x-rays placing patient at high risk of implant-related failure

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Routine Post-operative Physical Therapy; The control group will undergo routine post-op and undergo a modified version of the graduated therapy protocol.	Other: Routine Post-operative Physical Therapy; The control group with undergo a post-op therapy protocol that mirrors that of the intervention group except that they will use a Delfi tourniquet system blood pressure cuff with a limb occlusion pressure (LOP) of only 10%. Participants will use a neuromuscular electrical stimulation device operating at a sub-therapeutic level.
Experimental: Routine Physical Therapy + Blood Flow Restriction and Neuromuscular Electrical Stimulation (NMES); The intervention group will start with a Delfi tourniquet system cuff set on a limb occlusion pressure (LOP) of 60-100%. The intervention group will also use a neuromuscular electrical stimulation device at therapeutic level in addition to BFR.	Device: Blood Flow Restriction with Delfi Tourniquet System Cuff; Postoperative rehabilitation will occur up to twice a day for 5 days a week for 2 weeks using a Delfi tourniquet system blood pressure cuff with a limb occlusion pressure (LOP) of 60-100%. For each physical therapy session, participants will undergo therapy following a standardized protocol of 3-5 difference exercises each with 4 sets total in addition to NMES.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participants thigh circumference measurement	10cm proximal to superior pole patella and leg circumference measured at 10 distal to inferior pole patella for both extremities	At enrollment
Participants thigh circumference measurement	10cm proximal to superior pole patella and leg circumference measured at 10 distal to inferior pole patella for both extremities	Post op 2 weeks
Therapist-reported compliance and adverse event logs	Specify if able to perform specific exercises to completion or not	Post op 2 weeks
Objective muscle strength measured by a handheld dynamometer	To assess strength of quadriceps extension	At enrollment
Objective muscle strength measured by a handheld dynamometer	To assess strength of quadriceps extension	Post op 2 weeks
Participant self-reported outcome for pain	The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain." The range of scores are from 0-100. A higher score indicates greater pain intensity.	Post op 2 weeks
Participant self-reported outcome: Perceived Exertion (Borg Rating of Perceived Exertion)	To assess effort and exertion, breathlessness and fatigue during exercise	Post op 2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Timed Up and Go Test (TUG)	Measurement of the time in seconds for a person to rise from sitting from a standard arm chair, walk 3 meters, walk back to the chair, and sit down.	Post op 2 weeks
Modified 30-second sit-to-stand test	Measurement of the number of sit-to-stands a person can complete in 30 seconds.	Post op 2 weeks
Five-times sit to stand test	Measures lower extremity strength and function. Participants are asked to stand up from a seated position and sit down 5 times as quickly as possible.	Post op 2 weeks
Functional testing performed	5 Meter gait speed test	Post op 2 weeks
12-Item Short Form Health Survey (SF-12) (Mental Health Component)	This is a general health questionnaire with higher scores representing better health. A summary score from the SF-12 (Mental Health Component) will be reported. The score may be represented as a Z-score. The average summary score is 50 points with a standard deviation of 10 points.	Post op 2 weeks
12-Item Short Form Health Survey (SF-12) (Physical Health Component)	This is a general health questionnaire with higher scores representing better health. A summary score from the SF-12 (Physical Health Component) will be reported. The score may be represented as Z-score. The average of the summary score is 50 points with a standard deviation of 10 points.	Post op 2 weeks
Patient-Reported Outcomes Measurement Information System (PROMIS)	This questionnaire measures physical, mental, and social health. Higher scores represents more of the concept being measured. A score of 40 is one standard deviation lower than the mean of the reference population while a score of 60 is one standard deviation higher than the mean of the reference population.	Post op 2 weeks
Pain medicine requirements during 2-week stay	To assess the milligram morphine equivalents of pain medicine used.	Post op 2 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative complications: Mortality	Mortality will be assessed by living status.	Post op 2 weeks
Post-operative complications: Blood Clots	Blood clots will be assessed by a detailed physical examination.	Post op 2 weeks
Post-operative complications: Deep Infection	Deep infection will be assessed by the need to return to the operating room for surgical debridement or by the presence of positive cultures.	Post op 2 weeks
Post-operative complications: Nerve Damage	Nerve damage will be assessed by a detailed physical examination assessing both sensory and motor functions.	Post op 2 weeks
Number of patient-reported falls	To assess tolerance of BFR we will record the incidence of falls.	Post op 2 weeks

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Investigators: Study Director: David A Patch, MD, University of Alabama at Birmingham

Publications and helpful links

General Publications

• Centner C, Wiegel P, Gollhofer A, Konig D. Effects of Blood Flow Restriction Training on Muscular Strength and Hypertrophy in Older Individuals: A Systematic Review and Meta-Analysis. Sports Med. 2019 Jan;49(1):95-108. doi: 10.1007/s40279-018-0994-1. Erratum In: Sports Med. 2018 Nov 9;:
• Prabhakar NR. 2019 Nobel Prize in Physiology or Medicine. Physiology (Bethesda). 2020 Mar 1;35(2):81-83. doi: 10.1152/physiol.00001.2020. No abstract available.
• Bhandari M, Devereaux PJ, Swiontkowski MF, Tornetta P 3rd, Obremskey W, Koval KJ, Nork S, Sprague S, Schemitsch EH, Guyatt GH. Internal fixation compared with arthroplasty for displaced fractures of the femoral neck. A meta-analysis. J Bone Joint Surg Am. 2003 Sep;85(9):1673-81. doi: 10.2106/00004623-200309000-00004.
• Simunovic N, Devereaux PJ, Sprague S, Guyatt GH, Schemitsch E, Debeer J, Bhandari M. Effect of early surgery after hip fracture on mortality and complications: systematic review and meta-analysis. CMAJ. 2010 Oct 19;182(15):1609-16. doi: 10.1503/cmaj.092220. Epub 2010 Sep 13.
• Baker BS, Stannard MS, Duren DL, Cook JL, Stannard JP. Does Blood Flow Restriction Therapy in Patients Older Than Age 50 Result in Muscle Hypertrophy, Increased Strength, or Greater Physical Function? A Systematic Review. Clin Orthop Relat Res. 2020 Mar;478(3):593-606. doi: 10.1097/CORR.0000000000001090.
• Bowman EN, Elshaar R, Milligan H, Jue G, Mohr K, Brown P, Watanabe DM, Limpisvasti O. Proximal, Distal, and Contralateral Effects of Blood Flow Restriction Training on the Lower Extremities: A Randomized Controlled Trial. Sports Health. 2019 Mar/Apr;11(2):149-156. doi: 10.1177/1941738118821929. Epub 2019 Jan 14.
• Natsume T, Ozaki H, Saito AI, Abe T, Naito H. Effects of Electrostimulation with Blood Flow Restriction on Muscle Size and Strength. Med Sci Sports Exerc. 2015 Dec;47(12):2621-7. doi: 10.1249/MSS.0000000000000722.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Estimated): December 13, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: March 6, 2021
• First Submitted That Met QC Criteria: March 18, 2021
• First Posted (Actual): March 22, 2021

Study Record Updates

• Last Update Posted (Estimated): June 19, 2023
• Last Update Submitted That Met QC Criteria: June 16, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Geriatric; Muscle atrophy; Hip Surgery; Blood flow restriction therapy; Muscle disuse
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Wounds and Injuries; Leg Injuries; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Femoral Fractures; Hip Injuries; Muscular Atrophy; Fractures, Bone; Hip Fractures; Atrophy
• Other Study ID Numbers: IRB-300006887

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: To be determined.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes