Clinical trial NCT04100161: Nutritional Strategies After Muscle Strain Injuries
Official title: Skeletal Muscle Strain Injuries and the Connective Tissue: Optimal Nutritional Strategies During Rehabilitation After Acute Muscle Strain Injuries
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Muscle Strain, Multiple Sites
Keywords: muscle strain, atrophy, protein, rehabilitation
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
name: University Hospital Bispebjerg and Frederiksberg
First posted: 2019-09-24
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Muscle volume
timeFrame: 3 months post injury
Secondary outcomes:
measure: Muscle volume
timeFrame: 12 months post injury
measure: Isokinetic muscle strength
timeFrame: 3 months post injury
measure: Isokinetic muscle strength
timeFrame: 6 months post injury
measure: Isokinetic muscle strength
timeFrame: 12 months post injury
measure: Fat infiltration
timeFrame: 3 months post injury
measure: Fat infiltration
timeFrame: 12 months post injury
measure: Injury screening Questionnaire
timeFrame: 3 months post
measure: Injury screening Questionnaire
timeFrame: 6 months post
measure: Injury screening Questionnaire
timeFrame: 12 months post
measure: Ultrasound images
timeFrame: Baseline (Acute post injury)
measure: Ultrasound images
timeFrame: 3 months post injury
measure: Ultrasound images
timeFrame: 6 months post injury
measure: Ultrasound images
timeFrame: 12 months post injury
measure: Assessment injury exudate
timeFrame: Within 7 days post injury
measure: Assessment injury exudate
timeFrame: <1 week post injury -12 weeks post injury
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Institute of Sports Medicine Copenhagen, Bispebjerg Hospital, Nielsine Nielsen Vej 11, Building 8
Study officials:
affiliation: Institute of Sports Medicine, Copenhagen
name: Monika L Bayer, PhD
role: PRINCIPAL_INVESTIGATOR
References: