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

NCT04809714 | Active Not Recruiting FDA Device

• 2 other identifiers: IRB-300006887UL 1 TR003096
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hip Fractures; Muscle Atrophy

Keywords

Hip Surgery; Geriatric; Blood flow restriction therapy; Muscle atrophy; Muscle disuse

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (8)

• Timed Up and Go Test (TUG)

  Post op 2 weeks

• Modified 30-second sit-to-stand test

  Post op 2 weeks

• Five-times sit to stand test

  Post op 2 weeks

• Functional testing performed

  Post op 2 weeks

• 12-Item Short Form Health Survey (SF-12) (Mental Health Component)

  Post op 2 weeks

Other Outcomes (5)

• Post-operative complications: Mortality

  Post op 2 weeks

• Post-operative complications: Blood Clots

  Post op 2 weeks

• Post-operative complications: Deep Infection

  Post op 2 weeks

Study Arms (2)

Routine Post-operative Physical Therapy

ACTIVE COMPARATOR

The control group will undergo routine post-op and undergo a modified version of the graduated therapy protocol.

Other: Routine Post-operative Physical Therapy

Routine Physical Therapy + Blood Flow Restriction and Neuromuscular Electrical Stimulation (NMES)

EXPERIMENTAL

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

Interventions

Routine Post-operative Physical Therapy OTHER

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.

Routine Post-operative Physical Therapy

Blood Flow Restriction with Delfi Tourniquet System Cuff DEVICE

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.

Routine Physical Therapy + Blood Flow Restriction and Neuromuscular Electrical Stimulation (NMES)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35223, United States

Location

Related Publications (7)

• 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.

  PMID: 32024429 BACKGROUND

• 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.

  PMID: 12954824 BACKGROUND

• 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.

  PMID: 20837683 BACKGROUND

• 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.

  PMID: 31860546 BACKGROUND

• 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.

  PMID: 30638439 BACKGROUND

• 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.

  PMID: 30306467 BACKGROUND

• 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.

  PMID: 26110693 BACKGROUND

MeSH Terms

Conditions

Hip Fractures; Muscular Atrophy

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• David A Patch, MD

  University of Alabama at Birmingham

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The control group will undergo a graduated 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%. This is compared to the intervention group that will have a therapeutic LOP of 60-100%. This means that patients will have a cuff on their limb and are thus blinded to their group allocation but the pressure is set to such a low level that no additional effect on muscle hypertrophy is expected based on prior research.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: March 6, 2021
• First Posted: March 22, 2021
• Study Start: January 1, 2022
• Primary Completion (Estimated): December 13, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)