Hip FracturesNCT04809714
The Role of Blood Flow Restriction Therapy in Postoperative Elderly Patients With Hip Fracture
A study testing Blood Flow Restriction with Delfi Tourniquet System Cuff and Routine Post-operative Physical Therapy in people with Hip Fractures and Muscle Atrophy, run by University of Alabama at Birmingham at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hip Fractures, Muscle Atrophy
- What is being tested?
- Blood Flow Restriction with Delfi Tourniquet System Cuff and Routine Post-operative Physical Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2022to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35223
About this study
Official title: The Role of Blood Flow Restriction Therapy in the Postop Rehabilitation of Elderly Patients With Hip Fractures: A Randomized Controlled Pilot Study
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.
Read the 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.
- Conditions
- Hip Fractures, Muscle Atrophy
- Being tested
- Blood Flow Restriction with Delfi Tourniquet System Cuff, Routine Post-operative Physical Therapy
- Keywords
- Hip Surgery, Geriatric, Blood flow restriction therapy, Muscle atrophy, Muscle disuse
- Medical subject headings
- Hip Fractures, Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Flow Restriction with Delfi Tourniquet System CuffDevice
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.
Routine Post-operative Physical TherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Routine Post-operative Physical Therapy |
| 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. Receives: Device: Blood Flow Restriction with Delfi Tourniquet System Cuff |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants thigh circumference measurement
10cm proximal to superior pole patella and leg circumference measured at 10 distal to inferior pole patella for both extremities
Measured: 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
Measured: Post op 2 weeks
Therapist-reported compliance and adverse event logs
Specify if able to perform specific exercises to completion or not
Measured: Post op 2 weeks
Objective muscle strength measured by a handheld dynamometer
To assess strength of quadriceps extension
Measured: At enrollment
Objective muscle strength measured by a handheld dynamometer
To assess strength of quadriceps extension
Measured: 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.
Measured: Post op 2 weeks
Participant self-reported outcome: Perceived Exertion (Borg Rating of Perceived Exertion)
To assess effort and exertion, breathlessness and fatigue during exercise
Measured: Post op 2 weeks
Secondary outcomes (8)
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.
Measured: Post op 2 weeks
Modified 30-second sit-to-stand test
Measurement of the number of sit-to-stands a person can complete in 30 seconds.
Measured: 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.
Measured: Post op 2 weeks
Functional testing performed
5 Meter gait speed test
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Post op 2 weeks
Pain medicine requirements during 2-week stay
To assess the milligram morphine equivalents of pain medicine used.
Measured: Post op 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2021
- Study start1 Jan 2022
- Primary completion13 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Clay Spitler, University of Alabama at Birmingham
- Investigators
- David A Patch, MD, Study director, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04809714
- Sponsor's protocol ID
- IRB-300006887
- Other IDs
- UL 1 TR003096
- Status last verified
- Jan 2026
- First submitted
- 6 Mar 2021
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: To be determined.
Publications
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.
PubMed 32024429Bhandari 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.
PubMed 12954824Simunovic 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.
PubMed 20837683Baker 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.
PubMed 31860546Bowman 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.
PubMed 30638439Centner 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.
PubMed 30306467Natsume 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.
PubMed 26110693
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Blood Flow Restriction Therapy in the Postop Rehabilitation of Elderly Patients With Hip Fractures: A Randomized Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT04809714
- Acronym / sponsor ID
- IRB-300006887
- Conditions
- Hip Fractures, Muscle Atrophy
- Keywords
- Hip Surgery, Geriatric, Blood flow restriction therapy, Muscle atrophy, Muscle disuse
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 13 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 22 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine Post-operative Physical Therapy | Active comparator | Other: Routine Post-operative Physical TherapyThe 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 | Device: Blood Flow Restriction with Delfi Tourniquet System CuffThe 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood Flow Restriction with Delfi Tourniquet System CuffPostoperative 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. | Device | Routine Physical Therapy + Blood Flow Restriction and Neuromuscular Electrical Stimulation (NMES) |
| Routine Post-operative Physical TherapyThe 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. | Other | Routine Post-operative Physical Therapy |
Primary outcome
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
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
Therapist-reported compliance and adverse event logs
Time frame: Post op 2 weeks
Specify if able to perform specific exercises to completion or not
Objective muscle strength measured by a handheld dynamometer
Time frame: At enrollment
To assess strength of quadriceps extension
Objective muscle strength measured by a handheld dynamometer
Time frame: Post op 2 weeks
To assess strength of quadriceps extension
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.
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
8 secondary outcomes
Timed Up and Go Test (TUG)
Time frame: Post op 2 weeks
Modified 30-second sit-to-stand test
Time frame: Post op 2 weeks
Five-times sit to stand test
Time frame: Post op 2 weeks
Functional testing performed
Time frame: Post op 2 weeks
12-Item Short Form Health Survey (SF-12) (Mental Health Component)
Time frame: Post op 2 weeks
12-Item Short Form Health Survey (SF-12) (Physical Health Component)
Time frame: Post op 2 weeks
Patient-Reported Outcomes Measurement Information System (PROMIS)
Time frame: Post op 2 weeks
Pain medicine requirements during 2-week stay
Time frame: Post op 2 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Background: PubMed 32024429Prabhakar 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.
- Background: PubMed 12954824Bhandari 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.
- Background: PubMed 20837683Simunovic 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.
- Background: PubMed 31860546Baker 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.
- Background: PubMed 30638439Bowman 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.
- Background: PubMed 30306467Centner 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.
- Background: PubMed 26110693Natsume 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.
- Individual participant dataSharing planned: No. To be determined.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David A Patch, MD study director
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood Flow Restriction with Delfi Tourniquet System Cuff and Routine Post-operative Physical Therapy in people with Hip Fractures and Muscle Atrophy, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants thigh circumference measurement (time frame: At enrollment). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04809714, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.