Blood Flow Restriction Training After Bicep Tenodesis: A Pilot Study
试验速览
- 阶段
- 不适用
- 入组人数
- 56
- 主要终点
- Elbow Flexion Strength
研究概览
简要总结
A randomized controlled pilot study evaluating the effect of occlusion training on bone density and function of the upper extremity following a biceps tenodesis.
详细描述
Blood flow restriction training, resistance exercise performed with a specialized venous tourniquet, leads to beneficial changes in muscle strength at low resistance and minimal stress on the nearby joint. Early research further indicates that it improves systemic bone mineral density with change in bone turnover markers. This novel resistance training has the potential to improve muscle strength and bone density in individuals who are medically unable to perform high resistance exercises typically required to improve these attributes. Our study will examine the effect of occlusion training on bone density and function of the upper extremity following a bicep tenodesis. The primary objective of the intervention is to achieve improved bone density and accelerated recovery of upper extremity function as assessed using measures such as validated questionnaires, functional outcome testing, strength testing, and dual energy x-ray absorptiometry.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Selected to undergo a unilateral bicep tenodesis
- •Males and females age 18-65
- •DoD beneficiaries
- •Must be able to read and write in English in order to consent
排除标准
- •Contralateral upper extremity involvement resulting in less than normal range of motion, muscle strength, or daily pain greater than 1/
- •Rehabilitation protocol with prohibited muscle strengthening greater than 6 weeks post-operation.
- •Current metallic implants that contraindicate or significantly affect the sensitivity of DEXA scan
- •Current implanted defibrillator or pacemaker
- •Pregnancy - per patient self-report. Due to the expected small number of pregnant individuals and resulting inability to account for its effect on resulting outcomes, these patients will not be included in this study.
- •Recent history of deep vein thrombosis within the 12 months or on active treatment with anticoagulants
- •Currently taking medications that are known to affect bone density to include heparin, warfarin, glucocorticoids, medroxyprogesterone acetate, cancer treatment medications, bisphosphonates or other osteoporosis treatment medications, and thyroid hormone.
- •History of hyperparathyroidism
- •History of upper quadrant lymph node dissection
- •Patient endorsement of easy bruising
- •History of an upper extremity amputation
- •Active infection in the operative extremity
- •Cancer (current diagnosis per medical record)
研究组 & 干预措施
Occlusion Training
Patients undergoing a biceps tenodesis that are expected to begin a rehabilitation protocol with strength training by 6 weeks postoperatively for a continued 12 weeks course of 2-3 times per week of occupational therapy to include occlusion training.
干预措施: Delfi PTS II Portable Tourniquet System (Device)
Non-occlusion Training
Patients undergoing a biceps tenodesis that are expected to begin a rehabilitation protocol with strength training by 6 weeks postoperatively for a continued 12 weeks course of 2-3 times per week of occupational therapy without occlusion training (standard of care).
结局指标
主要结局
Elbow Flexion Strength
时间窗: 18 weeks
Elbow Flexion Strength will be assessed using the BTE PrimusRS dynamometer after the completion of the rehabilitation protocol, approximately 18 weeks postoperative. The patient will be seated with a lap belt to perform testing, to include isokinetic measurements of elbow flexion and forearm supination. The patient will perform 3 trials of one repetition on both the operative forearm and the contralateral arm of both elbow flexion and supination. The PrimusRS will generate a number of pounds of force used, which will be averaged for each side and used for analysis to represent strength. The BTE PrimusRS has been validated for measuring strength and used in numerous studies for various joints and movements to include elbow flexion and forearm supination
Operative Forearm Bone Density
时间窗: 24 weeks
Bone Density will be measured using the GE Lunar Dual Energy X-ray Absorptiometry (iDXA) device maintained and operated by the Nuclear Medicine clinic at SAMMC in accordance with the International Society for Clinical Densitometry (ISCD) Best Practices for dual energy x-ray absorptiometry guidance
Total Body Bone Density
时间窗: 24 weeks
Bone Density will be measured using the GE Lunar Dual Energy X-ray Absorptiometry (iDXA) device maintained and operated by the Nuclear Medicine clinic at SAMMC in accordance with the International Society for Clinical Densitometry (ISCD) Best Practices for dual energy x-ray absorptiometry guidance
Forearm Supination Strength
时间窗: 18 weeks
Forearm Supination Strength will be assessed using the BTE PrimusRS dynamometer after the completion of the rehabilitation protocol, approximately 18 weeks postoperative. The patient will be seated with a lap belt to perform testing, to include isokinetic measurements of elbow flexion and forearm supination. The patient will perform 3 trials of one repetition on both the operative forearm and the contralateral arm of both elbow flexion and supination. The PrimusRS will generate a number of pounds of force used, which will be averaged for each side and used for analysis to represent strength. The BTE PrimusRS has been validated for measuring strength and used in numerous studies for various joints and movements to include elbow flexion and forearm supination
Grip Strength
时间窗: 18 weeks.
Grip strength will be assessed using the JAMAR Hand Dynamometer. It has been selected for use in this study as per the recommendation by the American Society for the Surgery of the Hand and American Society of Hand Therapists ASHT) as the tool of choice to measure grip strength. Studies have shown that the JAMAR dynamometer has high instrument and test-retest reliability. Grip strength will be tested according to the testing position and procedure recommended by the ASHT. The mean of three successive trials will be recorded. There are established normative data for grip strength by both age and hand dominance.
次要结局
- Lumbar Spine Bone Density(24 weeks)
- Pain(24 weeks)
- Disability of the Arm, Shoulder, and Hand(24 weeks)
- Femoral Neck Bone Density(24 weeks)
- Functional Scale(24 weeks)
研究者
Griffin Holauchock
Orthopaedic Physician Assistant Certified Resident
Brooke Army Medical Center