Blood Flow Restriction Exercise for Older Adults Undergoing Knee Replacement Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Changes between the two group assessed by muscle strength
研究概览
简要总结
This pilot study will investigate the effects of blood flow restriction (BFR) exercise for up to 4-6 weeks prior to total knee arthroplasty (TKA) surgery in older patients to measure clinical outcomes such as strength, lower extremity function, and pain.
详细描述
The purpose of this study is to test the feasibility and efficacy of a low-resistance exercise protocol with blood flow restriction (BFR) using a tourniquet in the preoperative period of patients awaiting TKA. BFR exercise is a new exercise method that has not been studied in the perioperative period. The investigators will compare our intervention to a no-exercise group up to 4 - 6 weeks prior to surgery to determine if this type of exercise is feasible in the preoperative period and if BFR exercise will improve functional, physiological, and molecular outcomes when compared to patients without exercise.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •are scheduled for elective TKA for osteoarthritis
- •are scheduled for unilateral joint replacement surgery only
- •are able to give consent and follow instructions
- •are willing to complete up to 15 study visits
排除标准
- •patients below the age of 55 years old
- •patients over the age of 80 years old
- •patients who live in a radius greater than 45 miles from the University of Florida (a feasible distance to allow for transportation to and from the clinical center for assessment visits)
- •patients with impaired cognitive function and mental disease, (e.g. diagnosis of Alzheimer's disease)
- •patients with paraplegia/extremity amputation
- •patients with end stage renal disease requiring dialysis
- •patients with uncontrolled diabetes and insulin-dependent diabetes
- •patients with uncontrolled cardiovascular disease e.g. (Classes of Heart Failure (CHF) New York Heart Association (NYHA) class 3 or higher, BP > 180/110 mmHg)
- •patients with severe pulmonary disease requiring continuous oxygen therapy
- •patients with active neoplasm
- •patients with peripheral vascular disease or deep vein thrombosis (within the last 3 years)
- •patients with structured exercise/Physical Therapy(PT)/Occupational Therapy (OT)/fitness program enrollment within 12 weeks prior to surgery and/or more than 2 hours per month on gym/fitness room exercises
- •patients with BMI greater than 40 kg/m2
- •patients with opioid use of more than 30 mg Morphine-equivalents per day
- •patients with chronic oral steroid use
- •patients with chronic anticoagulation (e.g. Plavix, Warfarin)
- •patients with planned postoperative admission to a skilled nursing/inpatient rehab facility
- •patients with ipsilateral joint disease involving hip, ankle or spine
- •neurologic or other etiology of quadriceps wasting
- •surgery within less than 4 weeks
- •patients with comorbidities that the PI judges as not suitable for the study
- •patients with a minimal mental status (MMSE) score below 24
研究组 & 干预措施
NO-EX group
Subjects allocated to the No Exercise (NO-EX) group will undergo: Strength testing, Short Physical Performance Battery (SPPB), Six-minute walk (SMW), Numerical pain scale, Self-assessed function and Six-minute walk (SMW) test. Intra-op muscle biopsies.
干预措施: Six-minute walk (SMW) (Behavioral)
NO-EX group
Subjects allocated to the No Exercise (NO-EX) group will undergo: Strength testing, Short Physical Performance Battery (SPPB), Six-minute walk (SMW), Numerical pain scale, Self-assessed function and Six-minute walk (SMW) test. Intra-op muscle biopsies.
干预措施: Numerical pain scale (Behavioral)
NO-EX group
Subjects allocated to the No Exercise (NO-EX) group will undergo: Strength testing, Short Physical Performance Battery (SPPB), Six-minute walk (SMW), Numerical pain scale, Self-assessed function and Six-minute walk (SMW) test. Intra-op muscle biopsies.
干预措施: Self-assessed function (Behavioral)
NO-EX group
Subjects allocated to the No Exercise (NO-EX) group will undergo: Strength testing, Short Physical Performance Battery (SPPB), Six-minute walk (SMW), Numerical pain scale, Self-assessed function and Six-minute walk (SMW) test. Intra-op muscle biopsies.
干预措施: Muscle biopsies (Procedure)
NO-EX group
Subjects allocated to the No Exercise (NO-EX) group will undergo: Strength testing, Short Physical Performance Battery (SPPB), Six-minute walk (SMW), Numerical pain scale, Self-assessed function and Six-minute walk (SMW) test. Intra-op muscle biopsies.
干预措施: Strength testing (Device)
NO-EX group
Subjects allocated to the No Exercise (NO-EX) group will undergo: Strength testing, Short Physical Performance Battery (SPPB), Six-minute walk (SMW), Numerical pain scale, Self-assessed function and Six-minute walk (SMW) test. Intra-op muscle biopsies.
干预措施: Short Physical Performance Battery (SPPB) (Behavioral)
EX-BFR group
Subjects allocated to the EX-BFR group will undergo baseline strength testing, Short Physical Performance Battery (SPPB), Numerical pain scale, Six-minute walk (SMW), Self-assessed function, and determination of 1 Repetition Maximum (1-RM). Blood flow restriction exercise, Borg Category Ratio 10 (Borg CR10) scale. Intra-op muscle biopsies.
干预措施: Strength testing (Device)
EX-BFR group
Subjects allocated to the EX-BFR group will undergo baseline strength testing, Short Physical Performance Battery (SPPB), Numerical pain scale, Six-minute walk (SMW), Self-assessed function, and determination of 1 Repetition Maximum (1-RM). Blood flow restriction exercise, Borg Category Ratio 10 (Borg CR10) scale. Intra-op muscle biopsies.
干预措施: Short Physical Performance Battery (SPPB) (Behavioral)
EX-BFR group
Subjects allocated to the EX-BFR group will undergo baseline strength testing, Short Physical Performance Battery (SPPB), Numerical pain scale, Six-minute walk (SMW), Self-assessed function, and determination of 1 Repetition Maximum (1-RM). Blood flow restriction exercise, Borg Category Ratio 10 (Borg CR10) scale. Intra-op muscle biopsies.
干预措施: Six-minute walk (SMW) (Behavioral)
EX-BFR group
Subjects allocated to the EX-BFR group will undergo baseline strength testing, Short Physical Performance Battery (SPPB), Numerical pain scale, Six-minute walk (SMW), Self-assessed function, and determination of 1 Repetition Maximum (1-RM). Blood flow restriction exercise, Borg Category Ratio 10 (Borg CR10) scale. Intra-op muscle biopsies.
干预措施: Numerical pain scale (Behavioral)
EX-BFR group
Subjects allocated to the EX-BFR group will undergo baseline strength testing, Short Physical Performance Battery (SPPB), Numerical pain scale, Six-minute walk (SMW), Self-assessed function, and determination of 1 Repetition Maximum (1-RM). Blood flow restriction exercise, Borg Category Ratio 10 (Borg CR10) scale. Intra-op muscle biopsies.
干预措施: Self-assessed function (Behavioral)
EX-BFR group
Subjects allocated to the EX-BFR group will undergo baseline strength testing, Short Physical Performance Battery (SPPB), Numerical pain scale, Six-minute walk (SMW), Self-assessed function, and determination of 1 Repetition Maximum (1-RM). Blood flow restriction exercise, Borg Category Ratio 10 (Borg CR10) scale. Intra-op muscle biopsies.
干预措施: Muscle biopsies (Procedure)
EX-BFR group
Subjects allocated to the EX-BFR group will undergo baseline strength testing, Short Physical Performance Battery (SPPB), Numerical pain scale, Six-minute walk (SMW), Self-assessed function, and determination of 1 Repetition Maximum (1-RM). Blood flow restriction exercise, Borg Category Ratio 10 (Borg CR10) scale. Intra-op muscle biopsies.
干预措施: Determination of 1 Repetition Maximum (1-RM) (Device)
EX-BFR group
Subjects allocated to the EX-BFR group will undergo baseline strength testing, Short Physical Performance Battery (SPPB), Numerical pain scale, Six-minute walk (SMW), Self-assessed function, and determination of 1 Repetition Maximum (1-RM). Blood flow restriction exercise, Borg Category Ratio 10 (Borg CR10) scale. Intra-op muscle biopsies.
干预措施: Blood flow restriction exercise (Device)
EX-BFR group
Subjects allocated to the EX-BFR group will undergo baseline strength testing, Short Physical Performance Battery (SPPB), Numerical pain scale, Six-minute walk (SMW), Self-assessed function, and determination of 1 Repetition Maximum (1-RM). Blood flow restriction exercise, Borg Category Ratio 10 (Borg CR10) scale. Intra-op muscle biopsies.
干预措施: Borg CR10 scale (Behavioral)
结局指标
主要结局
Changes between the two group assessed by muscle strength
时间窗: Changes from baseline (pre-op) up to 2 weeks post-op
Test the strength of subject's lower extremity muscles on the dynamometer system
次要结局
- Changes between the two group assessed by Short Physical Performance Battery (SPPB)(Changes from baseline (pre-op) up to 2 weeks post-op)
- Changes between the two group assessed by self-assessment outcomes(Changes from baseline (pre-op) up to 2 weeks post-op)
- Changes between the two group assessed by pain(Changes from baseline (pre-op) up to 2 weeks post-op)
- Changes between the two group assessed by biological targets on the muscle tissue(Up to 4 hours (end of surgery))
- Changes between the two group assessed by Six-minute walk (SMW) test(Changes from baseline (pre-op) up to 2 weeks post-op)