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Nutritional Strategies After Muscle Strain Injuries

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ClinicalTrials.gov Identifier: NCT04100161
Recruitment Status : Not yet recruiting
First Posted : September 24, 2019
Last Update Posted : September 24, 2019
Sponsor:
Collaborators:
University of Copenhagen
University Hospital Bispebjerg and Frederiksberg
Information provided by (Responsible Party):
Monika Lucia Bayer, Bispebjerg Hospital

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, we 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.

Condition or disease Intervention/treatment Phase
Muscle Strain, Multiple Sites Dietary Supplement: Protein supplementation Dietary Supplement: Carbohydrate supplementation Procedure: Active rehabilitation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Skeletal Muscle Strain Injuries and the Connective Tissue: Optimal Nutritional Strategies During Rehabilitation After Acute Muscle Strain Injuries
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : August 31, 2022
Estimated Study Completion Date : August 1, 2029

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: Protein supplementation
20g protein supplementation twice daily for 3 months
Dietary Supplement: Protein supplementation
Daily dose of 40 g whey protein for 3 months

Procedure: Active rehabilitation
Progressive rehabilitation following a muscle strain injury for 3 months

Active Comparator: Carbohydrate supplementation
20g maltodextrin supplementation twice daily for 3 months
Dietary Supplement: Carbohydrate supplementation
Daily dose of 40 g maltodextrin for 3 months

Procedure: Active rehabilitation
Progressive rehabilitation following a muscle strain injury for 3 months




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04100161


Contacts
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Contact: Niels U Fredskild, BSc. +4530634862 qbs262@alumni.ku.dk
Contact: Kenneth H Mertz, MSc. +4522937397 khudlemertz@gmail.com

Locations
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Denmark
Institute of Sports Medicine Copenhagen, Bispebjerg Hospital, Nielsine Nielsen Vej 11, Building 8 Not yet recruiting
Copenhagen, Denmark, 2400
Contact: Monika L Bayer, PhD    +4525687931    Monika.Lucia.Bayer@regionh.dk   
Sponsors and Collaborators
Bispebjerg Hospital
University of Copenhagen
University Hospital Bispebjerg and Frederiksberg
Investigators
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Principal Investigator: Monika L Bayer, PhD Institute of Sports Medicine, Copenhagen

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Responsible Party: Monika Lucia Bayer, PhD, Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT04100161     History of Changes
Other Study ID Numbers: BBH P147
First Posted: September 24, 2019    Key Record Dates
Last Update Posted: September 24, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: 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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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Monika Lucia Bayer, Bispebjerg Hospital:
muscle strain, atrophy, protein, rehabilitation
Additional relevant MeSH terms:
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Sprains and Strains
Wounds and Injuries