Skeletal Muscle Strain Injuries and the Connective Tissue: Optimal Nutritional Strategies During Rehabilitation After Acute Muscle Strain Injuries
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
- 1
- 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:
- 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.
- The environment at the site of injury is not only pro-inflammatory, but contains proteins associated with proteolysis.
- 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
- 是
入选标准
- •Sports-active men and women
- •Acute muscle strain injury in either the calf muscles or the hamstring muscles
- •Visible tear at the muscle-connective tissue interface visible on an US scan as a hypo-/ hyperechoic area
排除标准
- •Unwillingness to return to sports
- •Claustrophobia
- •Daily intake of non-steroidal anti-inflammatory drugs (NSAIDs) within 3 months prior to the strain injury
- •Diagnosed or suspected type I or type II diabetes
- •Diagnosed or suspected connective tissue and/or rheumatic diseases
- •Any observed organ dysfunctions
研究组 & 干预措施
Protein supplementation
20g protein supplementation twice daily for 3 months
干预措施: Protein supplementation (Dietary Supplement)
Protein supplementation
20g protein supplementation twice daily for 3 months
干预措施: Active rehabilitation (Procedure)
Carbohydrate supplementation
20g maltodextrin supplementation twice daily for 3 months
干预措施: Carbohydrate supplementation (Dietary Supplement)
Carbohydrate supplementation
20g maltodextrin supplementation twice daily for 3 months
干预措施: Active rehabilitation (Procedure)
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)
- Isokinetic muscle strength(3 months post injury)
- Isokinetic muscle strength(6 months post injury)
- Fat infiltration(3 months post injury)
- Injury screening Questionnaire(3 months post)
- Injury screening Questionnaire(6 months post)
- Ultrasound images(Baseline (Acute post injury))
- Ultrasound images(3 months post injury)
- Ultrasound images(6 months post injury)
- Assessment injury exudate(Within 7 days post injury)
研究者
Monika Lucia Bayer
Senior Researcher
Bispebjerg Hospital