Nutritional Strategies After Muscle Strain Injuries

Study Overview
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Brief Summary
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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.

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

Conditions
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Muscle Strain, Multiple Sites

Intervention / Treatment
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* Dietary Supplement: Protein supplementation
* Dietary Supplement: Carbohydrate supplementation
* Procedure: Active rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: 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 Exclusion criteria: Unwillingness to return to sports Claustrophobia Daily intake of non-steroidal anti-inflammatory drugs (NSAIDs) within 3 months prior to the strain injury Smoking Diagnosed or suspected type I or type II diabetes Diagnosed or suspected connective tissue and/or rheumatic diseases Any observed organ dysfunctions

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Protein supplementation<br>20g protein supplementation twice daily for 3 months | Dietary Supplement: Protein supplementation<br>* Daily dose of 40 g whey protein for 3 months<br>Procedure: Active rehabilitation<br>* Progressive rehabilitation following a muscle strain injury for 3 months<br>|
| Active Comparator: Carbohydrate supplementation<br>20g maltodextrin supplementation twice daily for 3 months | Dietary Supplement: Carbohydrate supplementation<br>* Daily dose of 40 g maltodextrin for 3 months<br>Procedure: Active rehabilitation<br>* Progressive rehabilitation following a muscle strain injury for 3 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle volume | 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. | 3 months post injury | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle volume | Change in muscle volume in the injured muscle comparing immediate post injury scan with 12 months post scan plus comparison of change with healthy, contralateral muscle over the same time span. | 12 months post injury | 
| Isokinetic muscle strength | Change in muscle strength in the injured leg compared to muscle strength in healthy, contralateral muscle | 3 months post injury | 
| Isokinetic muscle strength | Change in muscle strength in the injured leg compared to muscle strength in healthy, contralateral muscle | 6 months post injury | 
| Isokinetic muscle strength | Change in muscle strength in the injured leg compared to muscle strength in healthy, contralateral muscle | 12 months post injury | 
| Fat infiltration | Assessment of fat content in the injured muscle comparing immediate post injury scan with 3 months post scan plus comparison of change with healthy, contralateral muscle over same time range | 3 months post injury | 
| Fat infiltration | Assessment of fat content in the injured muscle comparing immediate post injury scan with 12 months post scan plus comparison of change with healthy, contralateral muscle over same time range | 12 months post injury | 
| Injury screening Questionnaire | Assessment of subjective symptoms and pain during sports and daily activities | 3 months post | 
| Injury screening Questionnaire | Assessment of subjective symptoms and pain during sports and daily activities | 6 months post | 
| Injury screening Questionnaire | Assessment of subjective symptoms and pain during sports and daily activities | 12 months post | 
| Ultrasound images | Fascicle length measurement, pennation angle, mechanical properties of the muscle (- tendon unit) in the injured and healthy, contralateral muscle | Baseline (Acute post injury) | 
| Ultrasound images | Fascicle length measurement, pennation angle, mechanical properties of the muscle (- tendon unit) in the injured and healthy, contralateral muscle | 3 months post injury | 
| Ultrasound images | Fascicle length measurement, pennation angle, mechanical properties of the muscle (- tendon unit) in injured and healthy, contralateral muscle | 6 months post injury | 
| Ultrasound images | Fascicle length measurement, pennation angle, mechanical properties of the muscle (- tendon unit) in the injured and healthy, contralateral muscle | 12 months post injury | 
| Assessment injury exudate | Assessment and characterization of cells and soluble factors released after a strain injury into the intra-/ intermuscular space | Within 7 days post injury | 
| Assessment injury exudate | Assessment and characterization of cells and soluble factors released after a strain injury into the intra-/ intermuscular space | <1 week post injury -12 weeks post injury | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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muscle strain, atrophy, protein, rehabilitation