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

Hip Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04809714
• Other study ID #: IRB-300006887
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: June 2023
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: December 31, 2025
• Est. primary completion date: December 13, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrophy
• Fractures, Bone
• Hip Fractures
• Muscle Atrophy
• Muscular Atrophy

Intervention

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.

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.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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;: — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Post-operative complications: Mortality	Mortality will be assessed by living status.	Post op 2 weeks
Other	Post-operative complications: Blood Clots	Blood clots will be assessed by a detailed physical examination.	Post op 2 weeks
Other	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
Other	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
Other	Number of patient-reported falls	To assess tolerance of BFR we will record the incidence of falls.	Post op 2 weeks
Primary	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
Primary	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
Primary	Therapist-reported compliance and adverse event logs	Specify if able to perform specific exercises to completion or not	Post op 2 weeks
Primary	Objective muscle strength measured by a handheld dynamometer	To assess strength of quadriceps extension	At enrollment
Primary	Objective muscle strength measured by a handheld dynamometer	To assess strength of quadriceps extension	Post op 2 weeks
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	Functional testing performed	5 Meter gait speed test	Post op 2 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	Pain medicine requirements during 2-week stay	To assess the milligram morphine equivalents of pain medicine used.	Post op 2 weeks