Post-surgery Muscle Preservation Through Blood Flow Restriction Training in Orthopedic Spinal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Muscle Mass
研究概览
简要总结
This project investigates the effects of the Blood-Flow-Restriction (BFR) training method on postoperative muscle atrophy and pain after spinal surgery. Two groups are formed for this purpose. The intervention group receives a everyday BFR training during the postoperative stay at an individually measured occlusion pressure of 60-80%. The control group performs sham-BFR training at a fixed occlusion pressure of 20mmHg. The examinations are carried out before and several times after the operation (longest follow-up: 6 months). Among other things, muscle mass, muscle strength, pain perception and quality of life are assessed using questionnaires.
详细描述
Methodology and implementation Type of study
Prospective, interventional study in the context of clinical orthopedic routine (Non-AMG, Non-MPG):
This scientific project investigates the influence of blood-flow restriction training as a therapeutic intervention after spinal surgery for postoperative muscle preservation.
Study design Parallel study design The aim of this study is to investigate the influence of postoperative blood-flow restriction (BFR) application on muscle preservation and muscular-functional rehabilitation after spinal surgery. Postoperative muscle mass and strength loss is related not only to the size of the surgical procedure, but also to the prolonged rehabilitation after spine surgery. Since our patients are not able to perform large mechanical loads for a longer period of time (usually six weeks), we use the BFR training method as a training intervention.
The thesis of this work focuses the postoperative use of BFR training to reduce muscle atrophy during hospitalisation phase, and the supporting effects of BFR-Training on functional rehabilitation. For this purpose, a partially blinded randomised controlled trial will treat one group with BFR and one group with Sham-BFR and compare the results.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The study includes all patients with a medical indication for spinal surgical therapy (including herniated disc, vertebral fracture, spinal stenosis, spondylodiscitis, etc).
- •All participating patients have given their written informed consent to participate in the study.
- •Patients aged between 18-85 years will be included.
排除标准
- •Acute or chronic infections of the extremities.
- •Pregnancy and lactation
- •Inability to undergo surgery
研究组 & 干预措施
Control Group
The first group will serve as the control group and will receive an additional daily Sham BFR intervention of 20mmHg postoperatively as part of routine clinical care.
干预措施: Sham-BFR (Other)
Intervention Group
The second group will serve as the intervention group and will receive an additional daily passiveBFR intervention with 80% of the individual LOP postoperatively as part of routine clinical care.
干预措施: Blood-Flow-Restriction Training (Other)
结局指标
主要结局
Muscle Mass
时间窗: Pre- to 6 weeks Post Surgery
BIA-/ DXA-Measurement
次要结局
- Perceived Pain(Pre- to 6 weeks Post Surgery)
研究者
Alexander Franz
Dr. med., B.Sc.
University Hospital, Bonn