The Role of Blood Flow Restriction Therapy in the Postop Rehabilitation of Elderly Patients With Hip Fractures: A Randomized Controlled Pilot Study
概览
- 阶段
- 不适用
- 干预措施
- Routine Post-operative Physical Therapy
- 疾病 / 适应症
- Hip Fractures
- 发起方
- University of Alabama at Birmingham
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Participants thigh circumference measurement
- 状态
- 进行中（未招募）
- 最后更新
- 3个月前
概览
简要总结
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.
详细描述
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.
研究者
Clay Spitler
Principle Investigator
University of Alabama at Birmingham
入排标准
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Routine Post-operative Physical Therapy
The control group will undergo routine post-op and undergo a modified version of the graduated therapy protocol.
干预措施: Routine Post-operative Physical Therapy
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.
干预措施: Blood Flow Restriction with Delfi Tourniquet System Cuff
结局指标
主要结局
Participants thigh circumference measurement
时间窗: Post op 2 weeks
10cm proximal to superior pole patella and leg circumference measured at 10 distal to inferior pole patella for both extremities
Participant self-reported outcome: Perceived Exertion (Borg Rating of Perceived Exertion)
时间窗: Post op 2 weeks
To assess effort and exertion, breathlessness and fatigue during exercise
Therapist-reported compliance and adverse event logs
时间窗: Post op 2 weeks
Specify if able to perform specific exercises to completion or not
Objective muscle strength measured by a handheld dynamometer
时间窗: Post op 2 weeks
To assess strength of quadriceps extension
Participant self-reported outcome for pain
时间窗: 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.
Participants thigh circumference measurement
时间窗: At enrollment
10cm proximal to superior pole patella and leg circumference measured at 10 distal to inferior pole patella for both extremities
Objective muscle strength measured by a handheld dynamometer
时间窗: At enrollment
To assess strength of quadriceps extension
次要结局
- Modified 30-second sit-to-stand test(Post op 2 weeks)
- Timed Up and Go Test (TUG)(Post op 2 weeks)
- Patient-Reported Outcomes Measurement Information System (PROMIS)(Post op 2 weeks)
- Functional testing performed(Post op 2 weeks)
- 12-Item Short Form Health Survey (SF-12) (Physical Health Component)(Post op 2 weeks)
- Five-times sit to stand test(Post op 2 weeks)
- Pain medicine requirements during 2-week stay(Post op 2 weeks)
- 12-Item Short Form Health Survey (SF-12) (Mental Health Component)(Post op 2 weeks)