Muscle Strain, Multiple SitesNCT04100161
Nutritional Strategies After Muscle Strain Injuries
A study testing Protein supplementation, Carbohydrate supplementation and Active rehabilitation in people with Muscle Strain, Multiple Sites, run by Bispebjerg Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Muscle Strain, Multiple Sites
- What is being tested?
- Protein supplementation, Carbohydrate supplementation and Active rehabilitation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- 16 Jan 2020to 1 Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Institute of Sports Medicine Copenhagen, Bispebjerg Hospital, Nielsine Nielsen Vej 11, Building 8
Copenhagen, 2400
About this study
Official title: Skeletal Muscle Strain Injuries and the Connective Tissue: Optimal Nutritional Strategies During Rehabilitation After Acute 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.
Read more
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.
- Conditions
- Muscle Strain, Multiple Sites
- Being tested
- Protein supplementation, Carbohydrate supplementation, Active rehabilitation
- Keywords
- muscle strain, atrophy, protein, rehabilitation
- Medical subject headings
- Sprains and Strains, Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protein supplementationDietary supplement
Daily dose of 40 g whey protein for 3 months
Carbohydrate supplementationDietary supplement
Daily dose of 40 g maltodextrin for 3 months
Active rehabilitationProcedure or surgery
Progressive rehabilitation following a muscle strain injury for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Protein supplementation | Experimental | 20g protein supplementation twice daily for 3 months Receives: Dietary Supplement: Protein supplementation; Procedure: Active rehabilitation |
| Carbohydrate supplementation | Active comparator | 20g maltodextrin supplementation twice daily for 3 months Receives: Dietary Supplement: Carbohydrate supplementation; Procedure: Active rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months post injury
Secondary outcomes (15)
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.
Measured: 12 months post injury
Isokinetic muscle strength
Change in muscle strength in the injured leg compared to muscle strength in healthy, contralateral muscle
Measured: 3 months post injury
Isokinetic muscle strength
Change in muscle strength in the injured leg compared to muscle strength in healthy, contralateral muscle
Measured: 6 months post injury
Isokinetic muscle strength
Change in muscle strength in the injured leg compared to muscle strength in healthy, contralateral muscle
Measured: 12 months post injury
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
Measured: 3 months post injury
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
Measured: 12 months post injury
Injury screening Questionnaire
Assessment of subjective symptoms and pain during sports and daily activities
Measured: 3 months post
Injury screening Questionnaire
Assessment of subjective symptoms and pain during sports and daily activities
Measured: 6 months post
Injury screening Questionnaire
Assessment of subjective symptoms and pain during sports and daily activities
Measured: 12 months post
Ultrasound images
Fascicle length measurement, pennation angle, mechanical properties of the muscle (- tendon unit) in the injured and healthy, contralateral muscle
Measured: Baseline (Acute post injury)
Ultrasound images
Fascicle length measurement, pennation angle, mechanical properties of the muscle (- tendon unit) in the injured and healthy, contralateral muscle
Measured: 3 months post injury
Ultrasound images
Fascicle length measurement, pennation angle, mechanical properties of the muscle (- tendon unit) in injured and healthy, contralateral muscle
Measured: 6 months post injury
Ultrasound images
Fascicle length measurement, pennation angle, mechanical properties of the muscle (- tendon unit) in the injured and healthy, contralateral muscle
Measured: 12 months post injury
Assessment injury exudate
Assessment and characterization of cells and soluble factors released after a strain injury into the intra-/ intermuscular space
Measured: Within 7 days post injury
Assessment injury exudate
Assessment and characterization of cells and soluble factors released after a strain injury into the intra-/ intermuscular space
Measured: <1 week post injury -12 weeks post injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2019
- Study start16 Jan 2020
- Primary completion8 Jan 2024
- Study completion1 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Muscle Strain, Multiple SitesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen, University Hospital Bispebjerg and Frederiksberg
- Responsible party
- Principal investigator, Monika Lucia Bayer, Bispebjerg Hospital
- Investigators
- Monika L Bayer, PhD, Principal investigator, Institute of Sports Medicine, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04100161
- Sponsor's protocol ID
- BBH P147
- Status last verified
- Jan 2024
- First submitted
- 20 Sep 2019
- Last updated
- 10 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
Mertz KH, Sorensen HH, Lorentz C, Johansen E, Fredskild NU, Wulff MW, Svensson RB, Kjaer MB, Linden FH, Kjaer M, Bayer ML. Effects of Protein Supplementation During Early Rehabilitation on Muscle Volume and Function After Acute Muscle Strain Injuries: A Randomized Controlled Trial. Scand J Med Sci Sports. 2025 Apr;35(4):e70043. doi: 10.1111/sms.70043.
PubMed 40145631
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skeletal Muscle Strain Injuries and the Connective Tissue: Optimal Nutritional Strategies During Rehabilitation After Acute Muscle Strain Injuries
- ClinicalTrials.gov ID
- NCT04100161
- Acronym / sponsor ID
- BBH P147
- Conditions
- Muscle Strain, Multiple Sites
- Keywords
- muscle strain, atrophy, protein, rehabilitation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Collaborators
- University of Copenhagen, University Hospital Bispebjerg and Frederiksberg
- Study start
- 16 Jan 2020 (actual)
- Primary completion
- 8 Jan 2024 (actual)
- Study completion
- 1 Aug 2029 (estimated)
- First posted
- 24 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Protein supplementation | Experimental | Dietary Supplement: Protein supplementation, Procedure: Active rehabilitation20g protein supplementation twice daily for 3 months |
| Carbohydrate supplementation | Active comparator | Dietary Supplement: Carbohydrate supplementation, Procedure: Active rehabilitation20g maltodextrin supplementation twice daily for 3 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Protein supplementationDaily dose of 40 g whey protein for 3 months | Dietary supplement | Protein supplementation |
| Carbohydrate supplementationDaily dose of 40 g maltodextrin for 3 months | Dietary supplement | Carbohydrate supplementation |
| Active rehabilitationProgressive rehabilitation following a muscle strain injury for 3 months | Procedure or surgery | Carbohydrate supplementation, Protein supplementation |
Primary outcome
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.
15 secondary outcomes
Muscle volume
Time frame: 12 months post injury
Isokinetic muscle strength
Time frame: 3 months post injury
Isokinetic muscle strength
Time frame: 6 months post injury
Isokinetic muscle strength
Time frame: 12 months post injury
Fat infiltration
Time frame: 3 months post injury
Fat infiltration
Time frame: 12 months post injury
Injury screening Questionnaire
Time frame: 3 months post
Injury screening Questionnaire
Time frame: 6 months post
Injury screening Questionnaire
Time frame: 12 months post
Ultrasound images
Time frame: Baseline (Acute post injury)
Ultrasound images
Time frame: 3 months post injury
Ultrasound images
Time frame: 6 months post injury
Ultrasound images
Time frame: 12 months post injury
Assessment injury exudate
Time frame: Within 7 days post injury
Assessment injury exudate
Time frame: <1 week post injury -12 weeks post injury
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2024.
- Derived from this study: PubMed 40145631Mertz KH, Sorensen HH, Lorentz C, Johansen E, Fredskild NU, Wulff MW, Svensson RB, Kjaer MB, Linden FH, Kjaer M, Bayer ML. Effects of Protein Supplementation During Early Rehabilitation on Muscle Volume and Function After Acute Muscle Strain Injuries: A Randomized Controlled Trial. Scand J Med Sci Sports. 2025 Apr;35(4):e70043. doi: 10.1111/sms.70043.
- Individual participant dataSharing planned: No. 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.
Related trials for Muscle Strain, Multiple Sites
Not yet recruiting
Optimal Treatment of Acute Skeletal Muscle Injury
Muscle Strain, Multiple Sites, Inflammation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Monika L Bayer, PhD principal investigator
Institute of Sports Medicine, Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protein supplementation, Carbohydrate supplementation and Active rehabilitation in people with Muscle Strain, Multiple Sites, run by Bispebjerg Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle volume (time frame: 3 months post injury). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04100161, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2024.