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

Primary Purpose

Hip Fractures, Muscle Atrophy

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Blood Flow Restriction with Delfi Tourniquet System Cuff
Routine Post-operative Physical Therapy
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hip Fractures focused on measuring Hip Surgery, Geriatric, Blood flow restriction therapy, Muscle atrophy, Muscle disuse

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Routine Post-operative Physical Therapy

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

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Participants thigh circumference measurement
10cm proximal to superior pole patella and leg circumference measured at 10 distal to inferior pole patella for both extremities
Participants thigh circumference measurement
10cm proximal to superior pole patella and leg circumference measured at 10 distal to inferior pole patella for both extremities
Therapist-reported compliance and adverse event logs
Specify if able to perform specific exercises to completion or not
Objective muscle strength measured by a handheld dynamometer
To assess strength of quadriceps extension
Objective muscle strength measured by a handheld dynamometer
To assess strength of quadriceps extension
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.
Participant self-reported outcome: Perceived Exertion (Borg Rating of Perceived Exertion)
To assess effort and exertion, breathlessness and fatigue during exercise

Secondary Outcome Measures

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.
Modified 30-second sit-to-stand test
Measurement of the number of sit-to-stands a person can complete in 30 seconds.
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.
Functional testing performed
5 Meter gait speed test
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.
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.
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.
Pain medicine requirements during 2-week stay
To assess the milligram morphine equivalents of pain medicine used.

Full Information

First Posted
March 6, 2021
Last Updated
June 16, 2023
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT04809714
Brief Title
The Role of Blood Flow Restriction Therapy in Postoperative Elderly Patients With Hip Fracture
Official Title
The Role of Blood Flow Restriction Therapy in the Postop Rehabilitation of Elderly Patients With Hip Fractures: A Randomized Controlled Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
December 13, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures, Muscle Atrophy
Keywords
Hip Surgery, Geriatric, Blood flow restriction therapy, Muscle atrophy, Muscle disuse

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
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.
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Routine Post-operative Physical Therapy
Arm Type
Active Comparator
Arm Description
The control group will undergo routine post-op and undergo a modified version of the graduated therapy protocol.
Arm Title
Routine Physical Therapy + Blood Flow Restriction and Neuromuscular Electrical Stimulation (NMES)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Blood Flow Restriction with Delfi Tourniquet System Cuff
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Routine Post-operative Physical Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Participants thigh circumference measurement
Description
10cm proximal to superior pole patella and leg circumference measured at 10 distal to inferior pole patella for both extremities
Time Frame
At enrollment
Title
Participants thigh circumference measurement
Description
10cm proximal to superior pole patella and leg circumference measured at 10 distal to inferior pole patella for both extremities
Time Frame
Post op 2 weeks
Title
Therapist-reported compliance and adverse event logs
Description
Specify if able to perform specific exercises to completion or not
Time Frame
Post op 2 weeks
Title
Objective muscle strength measured by a handheld dynamometer
Description
To assess strength of quadriceps extension
Time Frame
At enrollment
Title
Objective muscle strength measured by a handheld dynamometer
Description
To assess strength of quadriceps extension
Time Frame
Post op 2 weeks
Title
Participant self-reported outcome for pain
Description
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.
Time Frame
Post op 2 weeks
Title
Participant self-reported outcome: Perceived Exertion (Borg Rating of Perceived Exertion)
Description
To assess effort and exertion, breathlessness and fatigue during exercise
Time Frame
Post op 2 weeks
Secondary Outcome Measure Information:
Title
Timed Up and Go Test (TUG)
Description
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.
Time Frame
Post op 2 weeks
Title
Modified 30-second sit-to-stand test
Description
Measurement of the number of sit-to-stands a person can complete in 30 seconds.
Time Frame
Post op 2 weeks
Title
Five-times sit to stand test
Description
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.
Time Frame
Post op 2 weeks
Title
Functional testing performed
Description
5 Meter gait speed test
Time Frame
Post op 2 weeks
Title
12-Item Short Form Health Survey (SF-12) (Mental Health Component)
Description
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.
Time Frame
Post op 2 weeks
Title
12-Item Short Form Health Survey (SF-12) (Physical Health Component)
Description
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.
Time Frame
Post op 2 weeks
Title
Patient-Reported Outcomes Measurement Information System (PROMIS)
Description
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.
Time Frame
Post op 2 weeks
Title
Pain medicine requirements during 2-week stay
Description
To assess the milligram morphine equivalents of pain medicine used.
Time Frame
Post op 2 weeks
Other Pre-specified Outcome Measures:
Title
Post-operative complications: Mortality
Description
Mortality will be assessed by living status.
Time Frame
Post op 2 weeks
Title
Post-operative complications: Blood Clots
Description
Blood clots will be assessed by a detailed physical examination.
Time Frame
Post op 2 weeks
Title
Post-operative complications: Deep Infection
Description
Deep infection will be assessed by the need to return to the operating room for surgical debridement or by the presence of positive cultures.
Time Frame
Post op 2 weeks
Title
Post-operative complications: Nerve Damage
Description
Nerve damage will be assessed by a detailed physical examination assessing both sensory and motor functions.
Time Frame
Post op 2 weeks
Title
Number of patient-reported falls
Description
To assess tolerance of BFR we will record the incidence of falls.
Time Frame
Post op 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David A Patch, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35223
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
To be determined.
Citations:
PubMed Identifier
32024429
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.
Results Reference
background
PubMed Identifier
12954824
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.
Results Reference
background
PubMed Identifier
20837683
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.
Results Reference
background
PubMed Identifier
31860546
Citation
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.
Results Reference
background
PubMed Identifier
30638439
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.
Results Reference
background
PubMed Identifier
30306467
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;:
Results Reference
background
PubMed Identifier
26110693
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.
Results Reference
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The Role of Blood Flow Restriction Therapy in Postoperative Elderly Patients With Hip Fracture

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