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Clinical Trials/NCT04100161
NCT04100161
Active, not recruiting
Not Applicable

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

Bispebjerg Hospital1 site in 1 country50 target enrollmentJanuary 16, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Muscle Strain, Multiple Sites
Sponsor
Bispebjerg Hospital
Enrollment
50
Locations
1
Primary Endpoint
Muscle volume
Status
Active, not recruiting
Last Updated
2 years ago

Overview

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.
Registry
clinicaltrials.gov
Start Date
January 16, 2020
End Date
August 1, 2029
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Monika Lucia Bayer

Senior Researcher

Bispebjerg Hospital

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Muscle volume

Time Frame: 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.

Secondary Outcomes

  • 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)

Study Sites (1)

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