Feasibility of Prehabilitation Blood-flow Restriction Training in Individuals Awaiting Total Knee Replacement.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Quadricep Muscle Strength
研究概览
简要总结
The aim is to demonstrate that preoperative exercises (pre-habilitation) using blood-flow restriction training (BFRT) is safe, well tolerated, improves muscle function, decreases functional limitation, and increases physical activity in older adults awaiting total knee replacement (TKR).
详细描述
Twenty individuals ≥60 years old awaiting TKR due to diagnosis of end-stage knee osteoarthritis who meet the inclusion/exclusion criteria will be invited to participate in a 6 weeks of low-intensity BFRT prehabilitation. We will assess muscle functional (i.e., cross-sectional area and intramuscular fatty content) using computerized tomography, quadriceps muscle strength using an isokinetic dynamometer, a battery of performance-based physical function, self-reported physical function and quality of life, and biomarkers of inflammation using blood serum. Feasibility assessment will be done by looking at safety (i.e., adverse events), compliance, and attrition rate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants are awaiting primary unilateral TKR due to diagnosis of end-stage KOA. Potential individuals must have at least 8 weeks waiting time in between study baseline assessment and surgery. This 8-week timeframe will allow for completion of baseline (T0) and follow-up assessments (T1: immediately after 6-week prehabilitation program);
- •are older than 60 years;
- •speak fluent English to reliably complete the study questionnaires and understand study instructions.
排除标准
- •have a history of cardiovascular disease, uncontrolled hypertension (blood pressure ≥140/90 mmHg), deep-vein thrombosis, varicose veins, or rhabdomyolysis;
- •have absolute contraindications to exercise, as established by the American College of Sports Medicine (uncontrolled arrhythmias, third degree heart block, recent EKG changes, unstable angina, acute myocardial infarction, and acute congestive heart failure);
- •report of 2 or more falls within the past year;
- •cannot walk a distance of 100 feet (30.5 meters) without an assistive device or need of a rest period;
- •have bilateral TKR or undergoing TKR revision or other total joint replacement in the lower extremities; or
- •have severe visual or hearing impairment. In addition to the affects that these impairments have on safety during participation in the intervention, they may also interfere with data collection (questionnaires and telephone checks);
- •have a lower extremity amputation;
- •are unable to comfortably bear weight on the affected knee;
- •have a BMI above
- •history of muscular disease (e.g., muscular dystrophy) or neurological disorder that may affect lower extremity function (e.g., cerebrovascular accident, neuropathy, Parkinson's disease, multiple sclerosis);
- •had additional surgery to the lower extremities within the past 12 months.
- •a Folstein Mini-Mental State Examination score of <
- •have acute or terminal illness;
- •are planning to have another TKR (primary on contralateral, or revision on same knee) within 4 months;
- •are planning to relocate to another city within 4 months.
- •Subjects with Sickle cell disease
- •lymphedema or vascular access restrictions
- •Subjects who have any on-going medical emergency
- •An ankle-brachial index outside of the expected range 0.9 and 1.3
结局指标
主要结局
Quadricep Muscle Strength
时间窗: Baseline, 8 weeks and 16 weeks
Quadricep Muscle Strength will be measured using an isokinetic dynamometer. Quadriceps femoris maximum voluntary isometric contraction (MVIC) as torque output (Nm) will be measured. Subjects will be seated in the dynamometer's chair with their knee at 60 degrees of flexion.
Leg Muscles Percentage of Fat Mass
时间窗: Baseline, 8 weeks and 16 weeks
Leg muscles % fat mass will be measured using a DXA scan.
Leg Muscles Lean Mass in Kilograms
时间窗: Baseline, 8 weeks and 16 weeks
Leg muscles lean mass in kilograms will be measured using a DXA scan.
次要结局
- 6-minute Walk Test(Baseline, 8 weeks and 16 weeks)
- Inflammatory Biomarkers(Baseline, 8 weeks and 16 weeks)
- Timed up and go Test(Baseline, 8 weeks and 16 weeks)
- Self-selected Gait Speed(Baseline, 8 weeks and 16 weeks)
- Real-time Physical Activity(Baseline, 8 weeks and 16 weeks)
- Health Related Quality of Life (RAND-36)(Baseline, 8 weeks and 16 weeks)
- 30-second Chair Stand Test(Baseline, 8 weeks and 16 weeks)
- Stair Climb Test(Baseline, 8 weeks and 16 weeks)
- Patient-Reported Physical Outcomes Measurement Information System (PROMIS(Baseline, 8 weeks and 16 weeks)
研究者
Gustavo Almeida
Assistant Professor
The University of Texas Health Science Center at San Antonio