Mechanisms of Tissue Repair After Muscle Injury and Tendon Strain

NCT ID: NCT05809947

Last Updated: 2024-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-11

Study Completion Date

2024-01-03

Brief Summary

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The study is a 5-week human study including 24 18-35 year old healthy men. Each participant will have muscle injury and tendon strain induced in one leg using neuromuscular electrical stimulation in conjunction with forced lengthening contractions. The investigators will monitor the recovery from injury/strain over a 4 week period, in which half of the subjects will receive growth hormone (somatropin) to stimulate the connective tissue synthesis.

Detailed Description

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Conditions

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Muscle; Injury, Quadriceps (Thigh) Tendon Strain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Growth hormone/somatropin

Somatropin over two weeks (33.3 ug/kg/day in the first week, 50 ug/kg/day in the second week)

Group Type EXPERIMENTAL

Neuromuscular electrical stimulation

Intervention Type OTHER

One bout of neuromuscular electrical stimulation in conjunction with forced lengthening contractions on one leg

Placebo

Injections of placebo/saline over two weeks

Group Type PLACEBO_COMPARATOR

Neuromuscular electrical stimulation

Intervention Type OTHER

One bout of neuromuscular electrical stimulation in conjunction with forced lengthening contractions on one leg

Interventions

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Neuromuscular electrical stimulation

One bout of neuromuscular electrical stimulation in conjunction with forced lengthening contractions on one leg

Intervention Type OTHER

Other Intervention Names

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Neuromuscular electrical stimulation using Theta 4 channel stimulator from Chattanooga. Coupled with forced eccentric contractions.

Eligibility Criteria

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Inclusion Criteria

* Healthy men
* BMI between 18.5-30 kg/m\^2

Exclusion Criteria

* Smoking
* Regular strength training within the last 3 months
* Current or former use of anabolic steroids or growth hormone
* Use of corticosteroids in the last 3 months
* Use of blood thinning medication
* Use of medication which can affect muscle protein synthesis
* Current or former drug og alcohol abuse
* Knee pain
* Previous participation in studies using deuterated water or alanine tracers
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Bispebjerg Hospital

OTHER

Sponsor Role lead

Responsible Party

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Grith Højfeldt

Principal investigator, postdoc

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Institute of Sports Medicine Copenhagen

Copenhagen, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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BBH150

Identifier Type: -

Identifier Source: org_study_id

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