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NCT Number: NCT04100161

Nutritional Strategies After Muscle Strain Injuries

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Muscle Strain, Multiple Sites Atrophy Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Sprains and Strains Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Sports Medicine Copenhagen, Bispebjerg Hospital, Nielsine Nielsen Vej 11, Building 8

Copenhagen, 2400, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Protein supplementation

Dietary Supplement

Daily dose of 40 g whey protein for 3 months

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

Primary outcomes

  1. 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

  1. Muscle volume

    Time frame: 12 months post injury

    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.

  2. Isokinetic muscle strength

    Time frame: 3 months post injury

    Change in muscle strength in the injured leg compared to muscle strength in healthy, contralateral muscle

  3. Isokinetic muscle strength

    Time frame: 6 months post injury

    Change in muscle strength in the injured leg compared to muscle strength in healthy, contralateral muscle

  4. Isokinetic muscle strength

    Time frame: 12 months post injury

    Change in muscle strength in the injured leg compared to muscle strength in healthy, contralateral muscle

  5. Fat infiltration

    Time frame: 3 months post injury

    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

  6. Fat infiltration

    Time frame: 12 months post injury

    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

  7. Injury screening Questionnaire

    Time frame: 3 months post

    Assessment of subjective symptoms and pain during sports and daily activities

  8. Injury screening Questionnaire

    Time frame: 6 months post

    Assessment of subjective symptoms and pain during sports and daily activities

  9. Injury screening Questionnaire

    Time frame: 12 months post

    Assessment of subjective symptoms and pain during sports and daily activities

  10. Ultrasound images

    Time frame: Baseline (Acute post injury)

    Fascicle length measurement, pennation angle, mechanical properties of the muscle (- tendon unit) in the injured and healthy, contralateral muscle

  11. Ultrasound images

    Time frame: 3 months post injury

    Fascicle length measurement, pennation angle, mechanical properties of the muscle (- tendon unit) in the injured and healthy, contralateral muscle

  12. Ultrasound images

    Time frame: 6 months post injury

    Fascicle length measurement, pennation angle, mechanical properties of the muscle (- tendon unit) in injured and healthy, contralateral muscle

  13. Ultrasound images

    Time frame: 12 months post injury

    Fascicle length measurement, pennation angle, mechanical properties of the muscle (- tendon unit) in the injured and healthy, contralateral muscle

  14. Assessment injury exudate

    Time frame: Within 7 days post injury

    Assessment and characterization of cells and soluble factors released after a strain injury into the intra-/ intermuscular space

  15. Assessment injury exudate

    Time frame: <1 week post injury -12 weeks post injury

    Assessment and characterization of cells and soluble factors released after a strain injury into the intra-/ intermuscular space

Sponsors and collaborators

Lead sponsor

Bispebjerg Hospital

Other

Collaborators

  • University Hospital Bispebjerg and Frederiksberg
  • University of Copenhagen

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2024
Study completion
2029
First posted
Sep 24, 2019
Registry last updated
Jan 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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