Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
4 participants
INTERVENTIONAL
2022-05-26
2023-05-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Standard of Care
Standard of Care Physical Therapy
Group 1 (Control) will receive standard of care physical therapy.
Blood Flow Restriction Supplemented
Blood Flow Restriction
Group 2 (experimental) will receive standard of care physical therapy to be done with blood flow restriction therapy (BFR). This method includes standard of care physical therapy while occluding blood flow.
Interventions
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Blood Flow Restriction
Group 2 (experimental) will receive standard of care physical therapy to be done with blood flow restriction therapy (BFR). This method includes standard of care physical therapy while occluding blood flow.
Standard of Care Physical Therapy
Group 1 (Control) will receive standard of care physical therapy.
Eligibility Criteria
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Inclusion Criteria
* Age 50 - 75
* Fall onto outstretched hand injury
Exclusion Criteria
* Fall from an elevated position greater than 12 inches
* Motor vehicle collision
* Any activity involving a powered vehicle (scooter, car, truck, ATV, motorcycle, tractor, etc.)
* any concomitant injury to the affected limb
* Bilateral distal radius fracture
* Revision procedures
* Worker's compensation status
* Non-English speaking
* No Internet Access
* Inability to provide informed consent
* Patients with known lymphovascular disorders, including peripheral arterial disease (PAD), prior deep vein thrombosis (DVT) or chronic lymphedema
* Patients with known genetic or other hypercoagulability disorders including those on long-term anticoagulation or anti-platelet therapy (other than prophylactic aspirin)
* Uncontrolled hypertension
* Patients with dialysis catheters or AV fistula
* Any other medical condition that affects the risk profile of the patient or that affects the normal physiologic function of the circulatory system of the extremities, based on sole discretion and medical judgement of the Primary Investigator
50 Years
75 Years
ALL
Yes
Sponsors
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Virginia Polytechnic Institute and State University
OTHER
Carilion Clinic
OTHER
Responsible Party
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Peter J Apel
Orthopaedic surgeon
Locations
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Carilion Clinic
Roanoke, Virginia, United States
Countries
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References
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Corsino CB, Reeves RA, Sieg RN. Distal Radius Fractures. 2023 Aug 8. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK536916/
Pope D, Tang P. Carpal Tunnel Syndrome and Distal Radius Fractures. Hand Clin. 2018 Feb;34(1):27-32. doi: 10.1016/j.hcl.2017.09.003.
Kooner P, Grewal R. Is Therapy Needed After Distal Radius Fracture Treatment, What Is the Evidence? Hand Clin. 2021 May;37(2):309-314. doi: 10.1016/j.hcl.2021.02.012.
Shinohara M, Kouzaki M, Yoshihisa T, Fukunaga T. Efficacy of tourniquet ischemia for strength training with low resistance. Eur J Appl Physiol Occup Physiol. 1998;77(1-2):189-91. doi: 10.1007/s004210050319.
Takarada Y, Takazawa H, Ishii N. Applications of vascular occlusion diminish disuse atrophy of knee extensor muscles. Med Sci Sports Exerc. 2000 Dec;32(12):2035-9. doi: 10.1097/00005768-200012000-00011.
Gundermann DM, Walker DK, Reidy PT, Borack MS, Dickinson JM, Volpi E, Rasmussen BB. Activation of mTORC1 signaling and protein synthesis in human muscle following blood flow restriction exercise is inhibited by rapamycin. Am J Physiol Endocrinol Metab. 2014 May 15;306(10):E1198-204. doi: 10.1152/ajpendo.00600.2013. Epub 2014 Apr 1.
Loenneke JP, Fahs CA, Wilson JM, Bemben MG. Blood flow restriction: the metabolite/volume threshold theory. Med Hypotheses. 2011 Nov;77(5):748-52. doi: 10.1016/j.mehy.2011.07.029. Epub 2011 Aug 12.
Fry CS, Rasmussen BB. Skeletal muscle protein balance and metabolism in the elderly. Curr Aging Sci. 2011 Dec;4(3):260-8. doi: 10.2174/1874609811104030260.
Nielsen JL, Aagaard P, Bech RD, Nygaard T, Hvid LG, Wernbom M, Suetta C, Frandsen U. Proliferation of myogenic stem cells in human skeletal muscle in response to low-load resistance training with blood flow restriction. J Physiol. 2012 Sep 1;590(17):4351-61. doi: 10.1113/jphysiol.2012.237008. Epub 2012 Jul 16.
Moritani T, Sherman WM, Shibata M, Matsumoto T, Shinohara M. Oxygen availability and motor unit activity in humans. Eur J Appl Physiol Occup Physiol. 1992;64(6):552-6. doi: 10.1007/BF00843767.
Wernbom M, Augustsson J, Raastad T. Ischemic strength training: a low-load alternative to heavy resistance exercise? Scand J Med Sci Sports. 2008 Aug;18(4):401-16. doi: 10.1111/j.1600-0838.2008.00788.x. Epub 2008 May 3.
Shakeel R, Khan AA, Ayyub A, Masood Z. Impact of strengthening exercises with and without blood flow restriction on quadriceps of knee osteoarthritis patients. J Pak Med Assoc. 2021 Sep;71(9):2173-2176. doi: 10.47391/JPMA.377.
Cheema AS, O'Brien PJ, Broekhuyse HM, Lefaivre KA. Measuring Outcomes Over Time in Distal Radius Fractures: A Comparison of Generic, Upper Extremity-Specific and Wrist-Specific Outcome Measures. J Hand Surg Glob Online. 2020 Aug 14;2(5):272-276. doi: 10.1016/j.jhsg.2020.06.006. eCollection 2020 Sep.
MacDermid JC. The PRWE/PRWHE update. J Hand Ther. 2019 Apr-Jun;32(2):292-294. doi: 10.1016/j.jht.2019.01.001. Epub 2019 Mar 25. No abstract available.
Other Identifiers
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IRB-21-1514
Identifier Type: -
Identifier Source: org_study_id
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