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临床试验/NCT04100161
NCT04100161进行中(未招募)不适用

Skeletal Muscle Strain Injuries and the Connective Tissue: Optimal Nutritional Strategies During Rehabilitation After Acute Muscle Strain Injuries

Bispebjerg Hospital2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年1月16日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
50
试验地点
2
主要终点
Muscle volume

研究概览

简要总结

Muscle strain injuries are a particularly frequent type of sports injury in soccer, athletics, badminton/ tennis and cross-fit fitness, thereby affecting a broad range of popular leisure time activities. Depending on severity, sports-active individuals may experience long-term functional impairment and pain. Additionally, individuals having sustained one strain injury have a substantially increased risk of injuring the same muscle again. Strain injuries lead to long-term, potentially permanent, loss of muscle mass, thereby weakening the muscle. Muscle atrophy is likely a major factor in the high re-injury risk. Further, strain injuries are associated with a long-term inflammatory response.

In the current study, the investigators seek to study interventions to prevent the loss of muscle mass and elaborate on strategies to address the prolonged inflammation observed at the site of the injured muscle.

The primary aim of this study is to investigate the effect of protein supplementation on the reduction of muscle atrophy following a severe muscle strain injury in comparison to a carbohydrate supplement. As a second purpose, this study aims to elaborate on findings of prolonged inflammation intra-/ intermuscular by large-scale protein analysis and the characterization of cells active at the site of injury.

The study includes the following hypotheses:

  1. Protein supplementation administered in combination with a gradually increasing loading regime (rehabilitation with weekly progression in load/ intensity) will be effective in reducing the injury-related loss of muscle mass.
  2. The environment at the site of injury is not only pro-inflammatory, but contains proteins associated with proteolysis.
  3. Cells belonging to the group of fibro-adipogenic progenitors will be accumulating intra- and inter-muscularly.

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
Double (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Muscle volume

时间窗: 3 months post injury

Change in muscle volume in the injured muscle comparing immediate post injury scan with 3 months post scan plus comparison of change with healthy, contralateral muscle over the same time span.

次要结局

  • Muscle volume(12 months post injury)
  • Fat infiltration(12 months post injury)
  • Ultrasound images(12 months post injury)
  • Isokinetic muscle strength(12 months post injury)
  • Injury screening Questionnaire(12 months post)
  • Assessment injury exudate(<1 week post injury -12 weeks post injury)

研究者

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

Monika Lucia Bayer

Senior Researcher

Bispebjerg Hospital

研究点 (2)

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