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| Name | Class |
|---|---|
| University of Copenhagen | OTHER |
| University Hospital Bispebjerg and Frederiksberg | OTHER |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Protein supplementation | Experimental | 20g protein supplementation twice daily for 3 months |
|
| Carbohydrate supplementation | Active Comparator | 20g maltodextrin supplementation twice daily for 3 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Protein supplementation | Dietary Supplement | Daily dose of 40 g whey protein for 3 months |
|
| 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 |
| 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 |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Monika L Bayer, PhD | Institute of Sports Medicine, Copenhagen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Sports Medicine Copenhagen, Bispebjerg Hospital, Nielsine Nielsen Vej 11, Building 8 | Copenhagen | 2400 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40145631 | Derived | Mertz KH, Sorensen HH, Lorentz C, Johansen E, Fredskild NU, Wulff MW, Svensson RB, Kjaer MB, Linden FH, Kjaer M, Bayer ML. Effects of Protein Supplementation During Early Rehabilitation on Muscle Volume and Function After Acute Muscle Strain Injuries: A Randomized Controlled Trial. Scand J Med Sci Sports. 2025 Apr;35(4):e70043. doi: 10.1111/sms.70043. |
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Individual de-identified participant data or other documents such as study protocol will not be shared with any third party. A potential change in the data sharing plan after registration will be acknowledged as a statement in a submitted/ published manuscript. A change in the data sharing statement will furthermore be updated in the registry record.
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| ID | Term |
|---|---|
| D013180 | Sprains and Strains |
| D001284 | Atrophy |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Carbohydrate supplementation | Dietary Supplement | Daily dose of 40 g maltodextrin for 3 months |
|
| Active rehabilitation | Procedure | Progressive rehabilitation following a muscle strain injury for 3 months |
|
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 |