NCT04050813

Brief Summary

Investigate the efficacy of the inercial Flywheel training protocol in modifying the architecture and function of the hamstrings in patients with a history of structural muscle injury vs conventional training. The researchers hypothesize that inercial Flywheel training protocol will be a useful strategy in the modification of the architecture and function of the hamstring in patients with a history of indirect structural muscle injury and decrease the recurrence.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2019

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

First Submitted

Initial submission to the registry

August 5, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 8, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

October 8, 2019

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 8, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 8, 2022

Completed
Last Updated

March 27, 2025

Status Verified

March 1, 2025

Enrollment Period

3.1 years

First QC Date

August 5, 2019

Last Update Submit

March 24, 2025

Conditions

Keywords

Hamstring InjuryFlywheel Inertial ResistanceHamstring architectureUltrasoundEccentric

Outcome Measures

Primary Outcomes (4)

  • Change in the architecture and morphology of the hamstring

    To assess change in architecture and morphology of the hamstring at 8 week. It will be performed by a medical specialist in diagnostic imaging with a A GE Voluson 730 Expert model ultrasound machine , with 6-12 MHz linear transducer. Panoramic images of the long portion of the biceps femoris and semitendinosus will be taken from its proximal insertion, In each muscle, muscle thickness, fascicle length, penetration angle and physiological cross-sectional area will be evaluated.

    0 and 8 week

  • Change in Maximun isometric strength

    To assess change in maximum isometric strength of hamstring in Newton (N). It will be measured in 3 repetitions with a hand dynamometer at two knee flexion angles.

    0 and 8 week

  • Change in Rate of force development

    To assess change in rate of force development of hamstring in N/seg at 8 week. it will be measured in 3 repetitions with a hand dynamometer at two knee flexion angles.

    0 and 8 week

  • Change in Maximun eccentric strength

    To assess the maximum eccentric strength of hamstring in Newton (N) from basiline. It will be measured in 3 repetitions with a hand held dynamometer.

    0 and 8 week

Secondary Outcomes (7)

  • Change in Oslo hamstring injury screening questionnaire

    0 and 8 week

  • Functional scale of the lower limb

    In the week before the 1st session of the protocol

  • Adverse events

    week 8

  • Adherence self-report questionnaire

    week 8

  • Maximum Hip Flexion Active Knee Extension (MHFAKE) Test

    0 and 8 week

  • +2 more secondary outcomes

Study Arms (2)

Control

EXPERIMENTAL

The program is performed 2 times per week using resistance equipment in a physiotherapy clinic. Each session consists of on 2-legged loaded exercises for hamstring, quadriceps, gluteus maximun and core. The patients complete 3 or 4 sets in each exercise with a 2- to 3-minute rest between sets and a 5-minute rest period between the 4 exercises. The number of repetitions decreases, and load gradually increases, every week. The repetitions and loads are as follows: 3 set of 12-repetition maximum (12RM), in week 1 and 2; 3 set of 10 RM, in week 3 and 4; 4 set of 10RM, in weeks 5 and 6; and 4 set of 8RM, in weeks 7 to 8.

Behavioral: Exercises program for hamstring architecture and function

Intervention

EXPERIMENTAL

Experimental: Inertial flywheel resistance training The program is performed 2 times per week using resistance equipment in a physiotherapy clinical. Inertial flywheel resistance is a type of strength training; which is based on the increasing demands on eccentric action (breaking) after a concentric action (acceleration), due to the inertial load caused during the return movement. The patients complete 16 repetition maximum (RM) with moment inertia 0.05 m² from week 1-2, 24 repetition maximum (RM) with moment inertia = 0.10 m² from week 3 to 4. 32 repetition maximum (RM) with moment inertia = 0.10 m² from week 5 to 6 and 32 repetition maximum (RM) with moment inertia = 0.13 m² in a flywheel hamstring curl devise.

Behavioral: Exercises program for hamstring architecture and function

Interventions

To assess the effectiveness of the inertial flywheel resistance program in the architecture and function of the hamstrings post structural hamstring injury

ControlIntervention

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Adults with history of structural muscle injuries type 3 of the Munich Consensus classification for muscular injuries, confirmed by imaging diagnosis no more than 2 years ago.
  • The patient must have performed conventional medical and physiotherapy treatment
  • Have Returned to their usual sporting activity
  • With good mental health.

You may not qualify if:

  • Suffer from a systemic pathology that could alter the healing biology of the muscle.
  • Present other lesions in the muscular group of extrinsic characteristic or not encompassed within type 3 structural lesions such as, for example, proximal or distal insertion tendinopathy, use of semitendinous as anterior cruciate ligament graft.
  • Prior knee or hip surgery.
  • Having been infiltrated with platelet rich plasma in the posterior thigth region in the previus 3 months before startin the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oulton GyMed, Rehabilitación y Gimnasio de Salud

Córdoba, Córdoba Province, 5000, Argentina

Location

MeSH Terms

Interventions

Functional Status

Intervention Hierarchy (Ancestors)

Activities of Daily LivingRehabilitationHealth ServicesHealth Care Facilities Workforce and ServicesHealth StatusDemographyEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Vilma Campana, Phd

    Departments of Biomedical Physics - University of Cordoba Argentina

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 5, 2019

First Posted

August 8, 2019

Study Start

October 8, 2019

Primary Completion

November 8, 2022

Study Completion

December 8, 2022

Last Updated

March 27, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations