Muscle Strain, Multiple Sites Clinical Trial
Official title:
Skeletal Muscle Strain Injuries and the Connective Tissue: Optimal Nutritional Strategies During Rehabilitation After Acute Muscle Strain Injuries
| Verified date | January 2024 |
| Source | Bispebjerg Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 50 |
| Est. completion date | August 1, 2029 |
| Est. primary completion date | January 8, 2024 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Denmark | Institute of Sports Medicine Copenhagen, Bispebjerg Hospital, Nielsine Nielsen Vej 11, Building 8 | Copenhagen |
| Lead Sponsor | Collaborator |
|---|---|
| Bispebjerg Hospital | University Hospital Bispebjerg and Frederiksberg, University of Copenhagen |
Denmark,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 | |
| Secondary | Isokinetic muscle strength | Change in muscle strength in the injured leg compared to muscle strength in healthy, contralateral muscle | 3 months post injury | |
| Secondary | Isokinetic muscle strength | Change in muscle strength in the injured leg compared to muscle strength in healthy, contralateral muscle | 6 months post injury | |
| Secondary | Isokinetic muscle strength | Change in muscle strength in the injured leg compared to muscle strength in healthy, contralateral muscle | 12 months post injury | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | Injury screening Questionnaire | Assessment of subjective symptoms and pain during sports and daily activities | 3 months post | |
| Secondary | Injury screening Questionnaire | Assessment of subjective symptoms and pain during sports and daily activities | 6 months post | |
| Secondary | Injury screening Questionnaire | Assessment of subjective symptoms and pain during sports and daily activities | 12 months post | |
| Secondary | 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) | |
| Secondary | 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 | |
| Secondary | Ultrasound images | Fascicle length measurement, pennation angle, mechanical properties of the muscle (- tendon unit) in injured and healthy, contralateral muscle | 6 months post injury | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT06274151 -
Optimal Treatment of Acute Skeletal Muscle Injury
|
N/A |