Nutritional Strategies After Muscle Strain Injuries

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.

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Muscle Strain, Multiple Sites
• Intervention / Treatment: Dietary supplement: Protein supplementation; Procedure: Active rehabilitation; Dietary supplement: Carbohydrate supplementation

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2400
    • Institute of Sports Medicine Copenhagen, Bispebjerg Hospital, Nielsine Nielsen Vej 11, Building 8

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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	Procedure: Active rehabilitation; Progressive rehabilitation following a muscle strain injury for 3 months; Dietary supplement: Carbohydrate supplementation; Daily dose of 40 g maltodextrin for 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months post injury

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months post injury
Isokinetic muscle strength	Change in muscle strength in the injured leg compared to muscle strength in healthy, contralateral muscle	3 months post injury
Isokinetic muscle strength	Change in muscle strength in the injured leg compared to muscle strength in healthy, contralateral muscle	6 months post injury
Isokinetic muscle strength	Change in muscle strength in the injured leg compared to muscle strength in healthy, contralateral muscle	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	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	12 months post injury
Injury screening Questionnaire	Assessment of subjective symptoms and pain during sports and daily activities	3 months post
Injury screening Questionnaire	Assessment of subjective symptoms and pain during sports and daily activities	6 months post
Injury screening Questionnaire	Assessment of subjective symptoms and pain during sports and daily activities	12 months post
Ultrasound images	Fascicle length measurement, pennation angle, mechanical properties of the muscle (- tendon unit) in the injured and healthy, contralateral muscle	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	3 months post injury
Ultrasound images	Fascicle length measurement, pennation angle, mechanical properties of the muscle (- tendon unit) in injured and healthy, contralateral muscle	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	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	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	<1 week post injury -12 weeks post injury

Collaborators and Investigators

• Sponsor: Bispebjerg Hospital
• Collaborators: University of Copenhagen; University Hospital Bispebjerg and Frederiksberg
• Investigators: Principal Investigator: Monika L Bayer, PhD, Institute of Sports Medicine, Copenhagen

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2020
• Primary Completion (Actual): January 8, 2024
• Study Completion (Estimated): August 1, 2029

Study Registration Dates

• First Submitted: September 20, 2019
• First Submitted That Met QC Criteria: September 23, 2019
• First Posted (Actual): September 24, 2019

Study Record Updates

• Last Update Posted (Actual): January 10, 2024
• Last Update Submitted That Met QC Criteria: January 9, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: muscle strain, atrophy, protein, rehabilitation
• Additional Relevant MeSH Terms: Wounds and Injuries; Sprains and Strains
• Other Study ID Numbers: BBH P147

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No