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临床试验/NCT04390035
NCT04390035招募中不适用

Blood Flow Restriction Training in the Adolescent Patient: Effects on Muscle Strength and Overall Function Following Anterior Cruciate Ligament Reconstruction Surgery

Children's Healthcare of Atlanta2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2020年9月23日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
120
试验地点
2
主要终点
Quadriceps Strength

研究概览

简要总结

This is an interventional study that will examine effects of blood flow restriction training (BFRT) in adolescents aged 12-18 after anterior cruciate ligament reconstruction surgery (ACLR). The study aims to identify the effect of BFRT on quadriceps muscle strength and the patient's quality of life, and the overall tolerability of BFRT will be examined. Eight physical therapists at four sports medicine physical therapy (PT) sites will oversee all post-operative PT sessions. Subjects allocated to the BFR group will undergo BFRT, while control group will undergo standard-of-care ACLR rehabilitation, 2 days per week for 16 weeks. Measurements of strength, quality of life, and overall function will be completed at regular intervals.

详细描述

Background:

Approximately 100,000 anterior cruciate ligament reconstructions (ACLR) are performed yearly, and rates of these surgeries in patients younger than 15 years increased by 924% between 1990 and 2007.1 Persistent strength deficits in quadriceps musculature following ACLR are common, even several months after surgery and despite targeted physical therapy to address atrophy.2 Quadriceps atrophy and weakness are associated with worse patient-reported outcomes (PROs),3 as well as altered movement strategies and increased risk of reinjury.4,6 Approximately 20% of teenagers returning to sports will sustain a second ACL injury in the first two years following their ACLR.5 Regaining neuromuscular activation and strength of the quadriceps muscle safely and efficiently is vital to full recovery, and current post-operative physical therapy regimens have not sufficiently addressed this impairment.

Strength training models recommend utilizing high resistance workloads to produce substantial strength gains,7 yet those recovering from orthopedic surgery are unable to tolerate heavy loads.8 Supplementing low-load resistance training with blood flow restriction (BFR-LLT) produces significant muscle hypertrophy and strength gains previously only thought to be achievable with high-load resistance training.9 BFR-LLT uses a tourniquet around the leg (see Appendix 4) to partially occlude venous return and decrease blood supply to the muscle being exercised. The generation of a low-oxygen environment and increases in plasma growth hormone levels has been shown to promote recruitment of motor units, improve neuromuscular activation, and result in muscular hypertrophy and growth.10-13 In adults and the elderly, improvements in quadriceps strength have been reported in up to 19%14 and increased quadriceps cross-sectional area in up to 6-7% compared to controls.15-16 To date there have only been four high-level studies investigating effects of BFR training in patients following ACLR17-20 and limited conclusions can be drawn from these studies due to lack of consistent methodology (variable cuff pressures and treatment frequency). More high-quality research is needed to determine treatment parameters that produce the most optimal results from this intervention in ACLR patients.

Additionally, there are no published randomized controlled trials investigating the effects of BFR training on exclusively adolescent patients. All high-quality BFR training research in patients following knee surgery have been conducted in late adolescent, young adult and adult populations.17-21 Therefore, the purpose of this study is to assess the effect of BFR-LLT on quadriceps strength and outcomes in adolescents following ACLR.

This study's adolescent-specific focus provides a significant contribution to ACLR research, as younger patients demonstrate higher risk of reinjury.22-24 The results from this preliminary study will ultimately provide data to guide clinicians in optimizing quadriceps strength and utilizing BFR-LLT in younger post-operative ACLR patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

盲法说明

Given that the intervention involves a device that will be physically applied to the participant's post-operative leg, masking is not feasible for this study.

入排标准

年龄范围
12 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Adolescent male and female patients, age 12-18
  • Skeletally mature at time of diagnosis, with closed growth plates, as determined via standard clinic x-ray imaging (this specification automatically excludes pre-pubescent children.
  • Underwent transphyseal ACLR with quadriceps tendon autograft with one of three sports orthopedic surgeons at CHOA
  • Completed pre-surgery strength assessment of bilateral quadriceps, hamstrings, hip abductor and hip adductor musculature.
  • English-speaking adolescents and parents of all races and ethnicities (after preliminary data is achieved, PI will coordinate a larger multi-center study that will include all non-English speaking participants.

排除标准

  • Skeletally immature patients with open growth plates, as determined via standard clinic x-ray imaging
  • Concomitant procedures performed during ACLR which require weight-bearing restrictions (i.e. meniscus repair, microfracture, multi-ligament knee reconstruction)
  • History of previous knee surgery
  • History of cardiovascular disease (e.g. coronary artery disease, unstable hypertension, vascular endothelial dysfunction, peripheral artery disease, varicose veins)
  • ICD-10 diagnosis of bleeding disorder (e.g. hemophilia or blood clotting disorder) or use of anticoagulants or other medications that may affect blood clotting
  • Inability to adhere to treatment protocol (as described in study procedures, BFR-LLT treatment requirements)
  • Any adverse events intra-operatively or post-operatively that lead to delay in care, including infection
  • Failure to adhere to attendance requirements as detailed below:
  • Attend first PT visit (PTV) within 5 days post-surgery
  • Attend a minimum of 20 total PTVs during weeks 1-16 post-surgery

结局指标

主要结局

Quadriceps Strength

时间窗: 0-24 weeks post-surgery

Quadriceps strength will be evaluated throughout the study using handheld dynamometry and percentage improvement will be compared between the control group and intervention group.

Hop Test Results

时间窗: 24 weeks

The hop test battery includes four hop tests (single leg hop for distance, triple hop for distance, 6-meter timed hop, triple crossover hop). Symmetry of performance between operative and non-operative lower extremity will be compared between control group and intervention group. The test will be performed at 24 weeks post-surgery.

Y-Balance Test Results

时间窗: 24 weeks

Symmetry of performance between operative and non-operative lower extremity will be compared between control group and intervention group. This test will be performed at 24 weeks post-surgery.

次要结局

  • Discomfort during BFRT via Visual Analogue Scale(0-16 weeks post-surgery)
  • Quality of life via Lysholm Knee Scale Score(At time of enrollment and 6, 12, and 24 weeks post-surgery)
  • Perceived Exertion during BFRT via the Children's OMNI Resistance Training Scale.(0-16 weeks post-surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jeanne Perkis

Clinical Site Supervisor, Physical Therapist

Children's Healthcare of Atlanta

研究点 (2)

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