Improving Tissue Repair After Injury in the Muscle-tendon Interface Muscle Tissue Injury

NCT ID: NCT05746650

Last Updated: 2025-09-24

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

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-24

Study Completion Date

2027-09-01

Brief Summary

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The study is a 2-week human study where 40 patients who are scheduled to undergo reconstructive knee surgery are randomized to administration of GH or placebo following or without neuromuscular electrical stimulation of hamstring muscles.The overall aim is to determine, the role of muscle connective tissue protein synthesis in muscle injury and repair.

Detailed Description

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Conditions

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Muscle Injury

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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1) Electrical stimulation + growth hormone

One bout of electrical stimulation with 200 eccentric contractions. This is followed by daily injections with somatropin (33.3 ug/kg in the first week, 50 ug/kg in the second week) for two weeks.

Group Type EXPERIMENTAL

Electrical stimulation

Intervention Type PROCEDURE

Experimentally induced muscly injury via. neuromuscular electrical stimulation of the hamstring muscles

Growth hormone (somatropin)

Intervention Type DRUG

Daily injection of growth hormone

2) Electrical stimulation

One bout of electrical stimulation with 200 eccentric contractions

Group Type EXPERIMENTAL

Electrical stimulation

Intervention Type PROCEDURE

Experimentally induced muscly injury via. neuromuscular electrical stimulation of the hamstring muscles

3) Growth hormone

Daily injections with somatropin (33.3 ug/kg in the first week, 50 ug/kg in the second week) for two weeks.

Group Type ACTIVE_COMPARATOR

Growth hormone (somatropin)

Intervention Type DRUG

Daily injection of growth hormone

4) Control

No intervention

Group Type PLACEBO_COMPARATOR

Control (No electrical stimulation, nor growth hormone)

Intervention Type OTHER

No electrical stimulation, nor growth hormone

Interventions

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Electrical stimulation

Experimentally induced muscly injury via. neuromuscular electrical stimulation of the hamstring muscles

Intervention Type PROCEDURE

Growth hormone (somatropin)

Daily injection of growth hormone

Intervention Type DRUG

Control (No electrical stimulation, nor growth hormone)

No electrical stimulation, nor growth hormone

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Healthy men and women scheduled to undergo reconstructive knee surgery
* BMI 18-35

Exclusion Criteria

* Former or current use of growth hormone or anabolic steroids
* Use of corticosteroids in the past 3 months
* Use of any medication known to affect muscle or tendon turnover
* Former participation in a study using deuterated water
* Chronic diseases
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

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

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Grith Højfeldt, PhD

Role: PRINCIPAL_INVESTIGATOR

Institute of Sports Medicine, Bispebjerg Hospital

Locations

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Bispebjerg Hospital

Copenhagen, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Grith Stougaard Højfeldt, PhD

Role: CONTACT

+45 61651061

Facility Contacts

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Grith Stougaard Højfeldt, PhD

Role: primary

+4561651061

Other Identifiers

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BBH158

Identifier Type: -

Identifier Source: org_study_id

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