NCT05000567

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 24, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 5, 2020

Completed
9 months until next milestone

First Posted

Study publicly available on registry

August 11, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

December 9, 2022

Status Verified

December 1, 2022

Enrollment Period

1.9 years

First QC Date

November 5, 2020

Last Update Submit

December 8, 2022

Conditions

Keywords

HamstringsStiffnessStrengthShear wave elastography

Outcome Measures

Primary Outcomes (3)

  • Change in hamstring muscle stiffness, measured by a Shear Wave elastography device.

    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.

    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.

    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.

Study Arms (3)

Control Group

NO INTERVENTION

No intervention.

Experimental Older group

EXPERIMENTAL

12 week strength training program: Nordic Hamstring Exercise

Other: 12 week nordic hamstring exercise program

Experimental Younger group

EXPERIMENTAL

12 week strength training program: Nordic Hamstring Exercise

Other: 12 week nordic hamstring exercise program

Interventions

12 weeks progressive eccentric strength training program targetting the hamstring muscles.

Experimental Older groupExperimental Younger group

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghent University

Ghent, 9000, Belgium

Location

Study Officials

  • Erik Witvrouw

    Departement of Rehabilitation Sciences, Ghent University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2020

First Posted

August 11, 2021

Study Start

September 24, 2020

Primary Completion

September 1, 2022

Study Completion

September 1, 2022

Last Updated

December 9, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations