Relationship Between Eccentric Hamstring Strength and Passive Muscle Stiffness

December 8, 2022 updated by: University Ghent
Ninety male subject will be divided into three group: a younger group (18-22y), an older group (30-40y) and a control group (18-40y). The study comprises 3 phases. PHASE 1: baseline strength and stiffness measurements of the hamstring muscles, PHASE 2: 12 week Nordic Hamstring strength training program (not for the control group) and PHASE 3: final strength and stiffness measurements. The aim of this study is twofold, namely to investigate (1) whether there is a difference in baseline stiffness of the hamstring muscle complex between different age categories and (2) the evolution of hamstring muscle stiffness during an eccentric strength training program within the different age groups. These two research questions could ultimately lead to a possible answer on the question if the higher probability of HSI (=hamstring strain injury) in the older age category with the lowest levels of eccentric hamstring strength could be due to an age-related difference in hamstring stiffness.

Study Overview

Status

Completed

Conditions

Detailed Description

Ninety male subjects will be equally allocated, according to their age, to either the younger NHE (Nordic Hamstring Exercise) group (aged between 18 and 22 years), the older NHE group (aged between 30 and 40 years) or the control group (aged between 18 and 40 years old). Potential candidates will be excluded from this study if they have a history of hamstring injuries, or a recent severe trauma or surgery in the lower extremity. All participants must perform at least 1 hour of weekly sport participation and do not participate in more than 3 training sessions a week. To ensure valid measurements of eccentric strength and muscle shear modulus, subjects will be instructed not to engage in strenuous training or sport activities 48 h prior to testing. All participants will be informed regarding the aim, content and possible risks associated with the experimental approach before they will be asked to sign an institutionally approved informed consent document, indicating voluntary participation in this study. Prior to the first training session, participants will undergo both a bilateral isokinetic eccentric and concentric strength protocol and an ultrasound elastographic assessment of the hamstring muscles to determine baseline strength (eccentric and concentric) and shear modulus of the posterior thigh muscles, respectively. Participants will be instructed not to engage in strenuous training or sport activities 48 h prior to testing to ensure a valid measure of the hamstring muscle-tendon elasticity. After completion of all the pre-training assessments, participants in the NHE groups will be familiarized with the correct execution-modalities of the eccentric hamstring exercise (NHE). For a period of 12 weeks, both experimental groups will perform a progressive eccentric strength training program targeting the hamstring muscles, solely consisting of the NHE. On the other hand, the control group will be instructed not to engage in any lower limb strength training. After completing the final training session, hamstring eccentric strength and shear modulus of all participants will be reassessed. The isokinetic strength protocol will be systematically conducted after all shear modulus measurements have been finished in order to avoid acute influences of previous exertion on the elasticity measurements.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Ghent, Belgium, 9000
        • Ghent University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Minimum 1h sport/week and Maximum 3 sport sessions a week
  • Male
  • Injury-free at the moment of testing.

Exclusion Criteria:

  • History of injuries or surgery lower extremity
  • History of hamstring injuries

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
No intervention.
Experimental: Experimental Older group
12 week strength training program: Nordic Hamstring Exercise
12 weeks progressive eccentric strength training program targetting the hamstring muscles.
Experimental: Experimental Younger group
12 week strength training program: Nordic Hamstring Exercise
12 weeks progressive eccentric strength training program targetting the hamstring muscles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in hamstring muscle stiffness, measured by a Shear Wave elastography device.
Time Frame: At baseline and after 12 weeks.

Via Shear Wave Elastography, the stiffness of the hamstring muscles (long head of the biceps femoris muscle, semitendinosus muscle and semimembranosus muscle) will be assessed. A shear wave elastography device (Aixplorer, version Mach 30, Supersonic Imagine, Aix-en-Provence, France) coupled with a linear transducer array (SL 18-5, 5-18 MHz. Super Linear, Vermon, Tours, France) will be used, in SWE mode (musculoskeletal preset, penetrate mode, smoothing level 5, persistence off, scale 0-100 kPa), to measure the shear modulus of the hamstrings (long head of the biceps femoris muscle, semitendinosus muscle and the semimembranosus muscle). The muscle stiffness will be depict by the passive shear modulus expressed in kilopascals (kPa).

Measurement: Hamstring muscle stiffness Measurement tool: Shear wave elastography Unit of measure: Shear modulus (kPa)

At baseline and after 12 weeks.
Change in eccentric strength (Peak Torque) of the hamstring muscle measured by a BIODEX 4 isokinetic device.
Time Frame: At baseline and after 12 weeks.

Via the BIODEX 4 isokinetic device (Biodex Medical Systems, New York, USA), the eccentric strength of the hamstring muscles will be assessed and expressed in Peak Torque (Nm/kg). The eccentric strength will be measured at two angular velocities: 30°/s and 120°/s.

Measurement: Eccentric muscle strength of the hamstring muscles Measurement tool: BIODEX isokinetic device Unit of measure: Peak Torque (Nm/kg) at 30°/s and at 120°/s.

At baseline and after 12 weeks.
Change in eccentric strength (Angle of peak torque) of the hamstring muscle, measured by a BIODEX 4 isokinetic device.
Time Frame: At baseline and after 12 weeks.

Via the BIODEX 4 isokinetic device (Biodex Medical Systems, New York, USA), the eccentric strength of the hamstring muscles will be assessed and expressed in Angle of Peak Torque (°). The eccentric strength will be measured at two angular velocities: 30°/s and 120°/s.

Measurement: Eccentric muscle strength of the hamstring muscles Measurement tool: BIODEX isokinetic device Unit of measure: Angle of Peak Torque (°) at 30°/s and at 120°/s.

At baseline and after 12 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 24, 2020

Primary Completion (Actual)

September 1, 2022

Study Completion (Actual)

September 1, 2022

Study Registration Dates

First Submitted

November 5, 2020

First Submitted That Met QC Criteria

August 10, 2021

First Posted (Actual)

August 11, 2021

Study Record Updates

Last Update Posted (Estimate)

December 9, 2022

Last Update Submitted That Met QC Criteria

December 8, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • B6702020000684

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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