We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04809714
Recruitment Status : Recruiting
First Posted : March 22, 2021
Last Update Posted : December 20, 2022
Sponsor:
Information provided by (Responsible Party):
Clay Spitler, University of Alabama at Birmingham

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.

Condition or disease Intervention/treatment Phase
Hip Fractures Muscle Atrophy Device: Blood Flow Restriction with Delfi Tourniquet System Cuff Other: Routine Post-operative Physical Therapy Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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.
Primary Purpose: Prevention
Official Title: The Role of Blood Flow Restriction Therapy in the Postop Rehabilitation of Elderly Patients With Hip Fractures: A Randomized Controlled Pilot Study
Actual Study Start Date : January 1, 2022
Actual Primary Completion Date : December 13, 2022
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Participants thigh circumference measurement [ Time Frame: At enrollment ]
    10cm proximal to superior pole patella and leg circumference measured at 10 distal to inferior pole patella for both extremities

  2. Participants thigh circumference measurement [ Time Frame: Post op 2 weeks ]
    10cm proximal to superior pole patella and leg circumference measured at 10 distal to inferior pole patella for both extremities

  3. Therapist-reported compliance and adverse event logs [ Time Frame: Post op 2 weeks ]
    Specify if able to perform specific exercises to completion or not

  4. Objective muscle strength measured by a handheld dynamometer [ Time Frame: At enrollment ]
    To assess strength of quadriceps extension

  5. Objective muscle strength measured by a handheld dynamometer [ Time Frame: Post op 2 weeks ]
    To assess strength of quadriceps extension

  6. Participant self-reported outcome for pain [ Time Frame: Post op 2 weeks ]
    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.

  7. Participant self-reported outcome: Perceived Exertion (Borg Rating of Perceived Exertion) [ Time Frame: Post op 2 weeks ]
    To assess effort and exertion, breathlessness and fatigue during exercise


Secondary Outcome Measures :
  1. Timed Up and Go Test (TUG) [ Time Frame: Post op 2 weeks ]
    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.

  2. Modified 30-second sit-to-stand test [ Time Frame: Post op 2 weeks ]
    Measurement of the number of sit-to-stands a person can complete in 30 seconds.

  3. Five-times sit to stand test [ Time Frame: Post op 2 weeks ]
    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.

  4. Functional testing performed [ Time Frame: Post op 2 weeks ]
    5 Meter gait speed test

  5. 12-Item Short Form Health Survey (SF-12) (Mental Health Component) [ Time Frame: Post op 2 weeks ]
    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.

  6. 12-Item Short Form Health Survey (SF-12) (Physical Health Component) [ Time Frame: Post op 2 weeks ]
    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.

  7. Patient-Reported Outcomes Measurement Information System (PROMIS) [ Time Frame: Post op 2 weeks ]
    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.

  8. Pain medicine requirements during 2-week stay [ Time Frame: Post op 2 weeks ]
    To assess the milligram morphine equivalents of pain medicine used.


Other Outcome Measures:
  1. Post-operative complications: Mortality [ Time Frame: Post op 2 weeks ]
    Mortality will be assessed by living status.

  2. Post-operative complications: Blood Clots [ Time Frame: Post op 2 weeks ]
    Blood clots will be assessed by a detailed physical examination.

  3. Post-operative complications: Deep Infection [ Time Frame: Post op 2 weeks ]
    Deep infection will be assessed by the need to return to the operating room for surgical debridement or by the presence of positive cultures.

  4. Post-operative complications: Nerve Damage [ Time Frame: Post op 2 weeks ]
    Nerve damage will be assessed by a detailed physical examination assessing both sensory and motor functions.

  5. Number of patient-reported falls [ Time Frame: Post op 2 weeks ]
    To assess tolerance of BFR we will record the incidence of falls.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04809714


Contacts
Layout table for location contacts
Contact: Clay A Spitler, MD 770-309-5377 caspitler@uabmc.edu
Contact: Matthew C Hess, MD 706-288-4070 mhess@uabmc.edu

Locations
Layout table for location information
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35223
Contact: Clay A Spitler, MD    770-309-5377    caspitler@uabmc.edu   
Contact: Matthew C Hess, MD    706-288-4070    mhess@uabmc.edu   
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Layout table for investigator information
Study Director: David A Patch, MD University of Alabama at Birmingham
Publications:

Layout table for additonal information
Responsible Party: Clay Spitler, Principle Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT04809714    
Other Study ID Numbers: IRB-300006887
First Posted: March 22, 2021    Key Record Dates
Last Update Posted: December 20, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: To be determined.

Layout table for additional information
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
Keywords provided by Clay Spitler, University of Alabama at Birmingham:
Hip Surgery
Geriatric
Blood flow restriction therapy
Muscle atrophy
Muscle disuse
Additional relevant MeSH terms:
Layout table for MeSH terms
Muscular Atrophy
Atrophy
Fractures, Bone
Hip Fractures
Wounds and Injuries
Pathological Conditions, Anatomical
Femoral Fractures
Hip Injuries
Leg Injuries
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases