Nutritional Strategies After Muscle Strain Injuries
Primary Purpose
Muscle Strain, Multiple Sites
Status
Active
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Protein supplementation
Carbohydrate supplementation
Active rehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Muscle Strain, Multiple Sites focused on measuring muscle strain, atrophy, protein, rehabilitation
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
Sites / Locations
- Institute of Sports Medicine Copenhagen, Bispebjerg Hospital, Nielsine Nielsen Vej 11, Building 8
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Protein supplementation
Carbohydrate supplementation
Arm Description
20g protein supplementation twice daily for 3 months
20g maltodextrin supplementation twice daily for 3 months
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Isokinetic muscle strength
Change in muscle strength in the injured leg compared to muscle strength in healthy, contralateral muscle
Isokinetic muscle strength
Change in muscle strength in the injured leg compared to muscle strength in healthy, contralateral muscle
Isokinetic muscle strength
Change in muscle strength in the injured leg compared to muscle strength in healthy, contralateral muscle
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
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
Injury screening Questionnaire
Assessment of subjective symptoms and pain during sports and daily activities
Injury screening Questionnaire
Assessment of subjective symptoms and pain during sports and daily activities
Injury screening Questionnaire
Assessment of subjective symptoms and pain during sports and daily activities
Ultrasound images
Fascicle length measurement, pennation angle, mechanical properties of the muscle (- tendon unit) in the injured and healthy, contralateral muscle
Ultrasound images
Fascicle length measurement, pennation angle, mechanical properties of the muscle (- tendon unit) in the injured and healthy, contralateral muscle
Ultrasound images
Fascicle length measurement, pennation angle, mechanical properties of the muscle (- tendon unit) in injured and healthy, contralateral muscle
Ultrasound images
Fascicle length measurement, pennation angle, mechanical properties of the muscle (- tendon unit) in the injured and healthy, contralateral muscle
Assessment injury exudate
Assessment and characterization of cells and soluble factors released after a strain injury into the intra-/ intermuscular space
Assessment injury exudate
Assessment and characterization of cells and soluble factors released after a strain injury into the intra-/ intermuscular space
Full Information
NCT ID
NCT04100161
First Posted
September 20, 2019
Last Updated
March 20, 2023
Sponsor
Bispebjerg Hospital
Collaborators
University of Copenhagen, University Hospital Bispebjerg and Frederiksberg
1. Study Identification
Unique Protocol Identification Number
NCT04100161
Brief Title
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
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 16, 2020 (Actual)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
August 1, 2029 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bispebjerg Hospital
Collaborators
University of Copenhagen, University Hospital Bispebjerg and Frederiksberg
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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:
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.
The environment at the site of injury is not only pro-inflammatory, but contains proteins associated with proteolysis.
Cells belonging to the group of fibro-adipogenic progenitors will be accumulating intra- and inter-muscularly.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Strain, Multiple Sites
Keywords
muscle strain, atrophy, protein, rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Protein supplementation
Arm Type
Experimental
Arm Description
20g protein supplementation twice daily for 3 months
Arm Title
Carbohydrate supplementation
Arm Type
Active Comparator
Arm Description
20g maltodextrin supplementation twice daily for 3 months
Intervention Type
Dietary Supplement
Intervention Name(s)
Protein supplementation
Intervention Description
Daily dose of 40 g whey protein for 3 months
Intervention Type
Dietary Supplement
Intervention Name(s)
Carbohydrate supplementation
Intervention Description
Daily dose of 40 g maltodextrin for 3 months
Intervention Type
Procedure
Intervention Name(s)
Active rehabilitation
Intervention Description
Progressive rehabilitation following a muscle strain injury for 3 months
Primary Outcome Measure Information:
Title
Muscle volume
Description
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.
Time Frame
3 months post injury
Secondary Outcome Measure Information:
Title
Muscle volume
Description
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.
Time Frame
12 months post injury
Title
Isokinetic muscle strength
Description
Change in muscle strength in the injured leg compared to muscle strength in healthy, contralateral muscle
Time Frame
3 months post injury
Title
Isokinetic muscle strength
Description
Change in muscle strength in the injured leg compared to muscle strength in healthy, contralateral muscle
Time Frame
6 months post injury
Title
Isokinetic muscle strength
Description
Change in muscle strength in the injured leg compared to muscle strength in healthy, contralateral muscle
Time Frame
12 months post injury
Title
Fat infiltration
Description
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
Time Frame
3 months post injury
Title
Fat infiltration
Description
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
Time Frame
12 months post injury
Title
Injury screening Questionnaire
Description
Assessment of subjective symptoms and pain during sports and daily activities
Time Frame
3 months post
Title
Injury screening Questionnaire
Description
Assessment of subjective symptoms and pain during sports and daily activities
Time Frame
6 months post
Title
Injury screening Questionnaire
Description
Assessment of subjective symptoms and pain during sports and daily activities
Time Frame
12 months post
Title
Ultrasound images
Description
Fascicle length measurement, pennation angle, mechanical properties of the muscle (- tendon unit) in the injured and healthy, contralateral muscle
Time Frame
Baseline (Acute post injury)
Title
Ultrasound images
Description
Fascicle length measurement, pennation angle, mechanical properties of the muscle (- tendon unit) in the injured and healthy, contralateral muscle
Time Frame
3 months post injury
Title
Ultrasound images
Description
Fascicle length measurement, pennation angle, mechanical properties of the muscle (- tendon unit) in injured and healthy, contralateral muscle
Time Frame
6 months post injury
Title
Ultrasound images
Description
Fascicle length measurement, pennation angle, mechanical properties of the muscle (- tendon unit) in the injured and healthy, contralateral muscle
Time Frame
12 months post injury
Title
Assessment injury exudate
Description
Assessment and characterization of cells and soluble factors released after a strain injury into the intra-/ intermuscular space
Time Frame
Within 7 days post injury
Title
Assessment injury exudate
Description
Assessment and characterization of cells and soluble factors released after a strain injury into the intra-/ intermuscular space
Time Frame
<1 week post injury -12 weeks post injury
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Monika L Bayer, PhD
Organizational Affiliation
Institute of Sports Medicine, Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Sports Medicine Copenhagen, Bispebjerg Hospital, Nielsine Nielsen Vej 11, Building 8
City
Copenhagen
ZIP/Postal Code
2400
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing 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.
Learn more about this trial
Nutritional Strategies After Muscle Strain Injuries
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