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临床试验/NCT03690700
NCT03690700招募中不适用

The Feasibility and Effects of Low-load Blood-flow Restricted Exercise Following Spinal Cord Injury

Spinal Cord Injury Centre of Western Denmark2 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2020年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
28
试验地点
2
主要终点
Changes in MVC

研究概览

简要总结

Spinal cord injury (SCI): The World Health Organization estimates an incidence of 250,000 to 500,000 per year worldwide. In Denmark 130 new cases of SCI per year. SCI is a devastating condition: paresis/paralysis of the skeletal muscles below the injury site, partial or complete inability to walk, move and/or feel. Other sequelae are: infections, lifestyle diseases (cardiovascular, diabetes, nephrologic disease), mental wellbeing/suicide-risk profoundly raised , quality of life, next-of-kin affection. Recovery of motor function is high clinical priority and crucial for improved ADL outcomes. Strength training regimens have shown improved muscle strength in healthy subjects using near-maximal voluntary effort contractions, and few studies have demonstrated similar effects in a SCI population. Atrophy and fatigability and spasticity may reduce practical implementation for rehabilitation. Therefore, low-load blood-flow restricted exercise (BFRE) may prove beneficial as supplement to traditional rehabilitation, increasing muscle strength and inducing hypertrophy in healthy persons. BFRE is performed as low-intensity strength training (20-30 % of max) while simultaneously involving the use of circumferential placement of cuffs during exercise, to maintain arterial inflow to the muscle while preventing venous return. Based on existing scientific evidence, BFRE is acknowledged as a safe regime without serious side effects. Previously, the method has shown increased muscle strength and inducing skeletal muscle hypertrophy in addition to improvement in gait performance in individuals with various diseases causing reduced mobility. Purposes of this PhD project: to investigate the feasibility and effects of BFRE in individuals living with the consequences of SCI.

详细描述

BACKGROUND Spinal cord injury (SCI) represents a major health concern; the World Health Organization estimates an incidence of 250,000 to 500,000 per year worldwide. On average in Denmark we register 130 new cases of SCI per year. SCI is a devastating condition, in which paresis/paralysis of the skeletal muscles below the injury site results in a partial or complete inability to walk, move and/or feel. Concurrent to functional disabilities, infections, lifestyle diseases such as cardiovascular diseases are frequent sequelae due to inactivity and overweight. Affecting primarily younger and previously healthy individuals traumatic SCI also profoundly impacts the mental wellbeing of the patients and also their next-of-kin; quality of life (QoL) suffers and subsequently the risk of suicide for patients with SCI increases by two to five times as compared to the background population.

While a substantial effort is being put into the rehabilitation of individuals with SCI, large gaps in knowledge still exist on this area. Recovery of motor function is of high clinical priority as it is fundamental for improved ADL outcomes.

While various strength training regimens have been shown to increase muscle strength in neurologically intact individuals using near-maximal voluntary effort contractions, few studies have demonstrated similar effects from strength training regimens in persons with SCI. Complications such as atrophy and easily fatigable neuromuscular system with various degrees of spasticity often make these kinds of regimes less practical and rewarding for rehabilitation. Therefore, the addition of low-load blood-flow restricted exercise (BFRE) may prove beneficial as a supplement to traditional rehabilitation. Notable, BFRE is found to increase muscle strength and induces skeletal muscle hypertrophy in healthy individuals. Typically, BFRE is performed as low-load strength training (20-30 % 1 Repetition Maximum (RM)) combined with concurrent partial occlusion of limb blood flow by means of pneumatic cuffs placed proximal at the limb, to restrit arterial inflow to the exercising muscle and preventing venous return. Based on existing scientific evidence and applying pre-exercisescreening for known risk factors such as vascular dysfunction (AD) or prior history of trombosis, BFRE is acknowledged as a safe exercise regime without serious side effects. Previously, the method has shown increased muscle strength and skeletal muscle hypertrophy in addition to improvements in gait and sit-to-stand performance in individuals with various diseases causing reduced mobility.

The aim of this PhD project is to;

  1. To conduct a pilot study for investigate the safety and feasibility of low-load BFRE training in adults with SCI
  2. To conduct a RCT to investigate the effects of low-load blood-flow restricted exercise (BFRE) on physical function and neuromuscular recovery in individuals with SCI

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)

盲法说明

Prior to the first training session, participants will be block-randomized to either active BFRE (n=12) or sham BFRE (n=12), (control for gender). The participants will be blinded from the randomization

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

入选标准

  • Duration of SCI > 1 year,
  • 18 years of age or older
  • Exhibit a grade 2, 3 or 4 muscle function of the knee flexors and/or extensors
  • Classification of grades A, B, C or D on the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) scale
  • Cognitive ability to follow instructions

排除标准

  • Substance abuse
  • Severe mental illness
  • Uncontrolled hypertension
  • Severe arteriosclerosis, coronary arterial disease
  • History of severe autonomic dysreflexia
  • Deep venous thrombosis (or severe coagulation dysfunction)
  • Collagen diseases such as Ehlers-Danlos Syndrome and Marfan's Syndrome
  • Severe neuropathies

结局指标

主要结局

Changes in MVC

时间窗: 1 week before treatment; 4-, 8- and 12-weeks after start of treatment

Changes in maximum, voluntary, isometric muscle strength (Muscle torque, MVC) of the m. quadriceps and hamstrings from baseline to follow-up

次要结局

  • Timed 10 Meter Walk Test(1 week before treatment; 4-, 8- and 12-weeks after start of treatment)
  • Walking Index for Spinal Cord Injury (WISCI-II)(1 week before treatment; 4-, 8- and 12-weeks after start of treatment)
  • Changes in quality of life(1 week before treatment; 4-, 8- and 12-weeks after start of treatment)
  • Changes in WHODAS 2.0(1 week before treatment; 4-, 8- and 12-weeks after start of treatment)
  • Changes in blood marker - Growth hormone, Insulin-like growth factor 1 (IGF-1), creatine kinase, cortisol, testosterone, myoglobin(Immediately before and three hours after the first training session. Additionally, 4-, 8- and 12-weeks after start of treatment)
  • Changes in accelerometer data(Accelerometer data will be obtained 3 x 1 week prior to and during the intervention period.)
  • 6 Minute Walk Test(1 week before treatment; 4-, 8- and 12-weeks after start of treatment)
  • Change in Rate of force development (RFD)(1 week before treatment; 4-,8- and 12-weeks after start of treatment)
  • Change in muscle and tendon thickness(1 week before treatment; 4-, 8- and 12-weeks after start of treatment)
  • Change in The Spinal Cord Ability Ruler (SCAR)(1 week before treatment; 4-, 8- and 12-weeks after start of treatment)
  • Timed Up & Go Test (TUG)(1 week before treatment; 4-, 8- and 12-weeks after start of treatment)
  • Change in self-reported, neuropathic pain level(1 week before treatment; 4-, 8- and 12-weeks after start of treatment)

研究者

发起方
Spinal Cord Injury Centre of Western Denmark
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jørgen Feldbæk Nielsen

Research Director, Professor; PhD

Spinal Cord Injury Centre of Western Denmark

研究点 (2)

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