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| ID | Type | Description | Link |
|---|---|---|---|
| UL 1 TR003096 | Other Grant/Funding Number | Foundation for Orthopaedic Trauma |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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) |
| 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 |
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David A Patch, MD | University of Alabama at Birmingham | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35223 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32024429 | Background | 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. | |
| 12954824 | 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. |
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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.
|
| 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. |
|
To assess effort and exertion, breathlessness and fatigue during exercise
| Post op 2 weeks |
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 |
| 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 |
| 20837683 | 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. |
| 31860546 | 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. |
| 30638439 | 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. |
| 30306467 | 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. |
| 26110693 | 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. |
| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| D009133 | Muscular Atrophy |
| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
| D007869 | Leg Injuries |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
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