NCT06538467

Brief Summary

The main objective of this study is to investigate training-induced adaptations in Biceps femoris long head (BFlh) architecture and performance measures such as muscle strength, jumping, and power variables after following 6 weeks of resistance training program with gravitational or inertial hip extension (HE) exercise and a subsequent detraining period, comparing those adaptations with a control group. In addition, this study aims to determine the time course of BFlh architectural adaptations throughout a 6-week training intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 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

Study Start

First participant enrolled

September 1, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

July 27, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 5, 2024

Completed
Last Updated

August 9, 2024

Status Verified

August 1, 2024

Enrollment Period

1.8 years

First QC Date

July 27, 2024

Last Update Submit

August 5, 2024

Conditions

Outcome Measures

Primary Outcomes (5)

  • Fascicle length

    Two-dimensional images of the Biceps femoris long head (BFlh) architecture were captured using B-mode ultrasonography. All imaging was conducted with participants lying prone with their hips and knees in a neutral and fully extended position.Three ultrasound images were taken and stored for analysis through the ImageJ software (National Institutes of Health, USA). The most visible fascicle in each image was used for measurement of fascicle pennation angle (i.e., angle between the fascicle and the intermediate aponeurosis) and estimation of fascicle length using a validated equation: FL = sin (AA + 90°) × MT ÷ sin (180° - (AA + 180° - PA))

    Baseline, at weeks 2 and 3 of the intervention, at the end of the 6 weeks of training and 4 weeks after this (detraining period)

  • Muscle Strength Assessment

    Knee flexion was assessed with subjects in prone position performing knee flexor maximal isometrics contractions with a knee angle of approximately 15 degrees. For hip extension, a resisted hip extension was requested with the subjects lying in the prone position with their legs straight. Hip adduction was evaluated in a supine position with the hips at 45º flexion, requesting an maximal isometrics contraction adduction with a resistance in the internal condyle.

    Baseline, at the end of the 6 weeks of training and 4 weeks after this (detraining period)

  • Jump performance

    CMJ and SJ, utilizing the MyJump 2 application on an iPad Pro (at 240 frames per second, high-definition video resolution). In the CMJ, participants initiated the jump from a standing position, performed a preparatory movement by bending their knees to 90° flexion, and then jumped upward as high as possible without pausing between movements. Similarly, for the SJ, participants began from a standardized position with knees flexed at 90°, and then jumped as high as possible with hands on their hips. Throughout both tests, participants were instructed to maintain their hands on their hips to minimize lateral and horizontal displacement, ensuring accurate vertical jump measurement.

    Baseline, at the end of the 6 weeks of training and 4 weeks after this (detraining period)

  • Power

    Power was calculated in both modalities (i.e., HE gravitational and inertial) as the product of velocity and force. The velocity was calculated using the MuscleLab 4020e linear encoder (Ergotest Technology AS, Porsgrunn, Norway). For gravitational loading (i.e. constant mass), the force was calculated as the product of mass and acceleration. For inertial loading, the force was calculated using a force gauge that was anchored along the rope, between a pulley and the proximal end of the second rope.

    Baseline, at the end of the 6 weeks of training and 4 weeks after this (detraining period)

  • Soreness

    Participants were asked "How sore do you feel in your hamstrings?" and rated their soreness on a 10-point Likert Scale (1 = No Soreness, 3 = Minimal Soreness, 5 = Moderate Soreness, 8 = Very Sore, 10 = Extremely Sore)

    From session 1 (the beginning of week 1) to session 12 (the end of week 6), at the beginning and end of each session.

Study Arms (3)

Inertial

EXPERIMENTAL

Hip extension exercise performed under inertial loading conditions using the EPTE Inertial Concept (Ionclinics SL, L'Alcudia, Spain) during six weeks with two sessions per week. The EPTE Inertial Concept is an inertial device that combines a series of output pulleys and telescopic arms, capable of implementing 6 disks of different weights and radii.

Other: Hip extension exercise with inertial load

Gravitational

EXPERIMENTAL

Hip extension exercise performed under gravitational loading conditions using free-weight equipment during six weeks with two sessions per week.

Other: Hip extension exercise with gravitational load

Control

NO INTERVENTION

Participans was advised to continue their regular levels of physical activity but not to perform any lower body resistance training

Interventions

Hip extension exercise with inertial load

Inertial

Hip extension exercise with gravitational load

Gravitational

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • at least two years of resistance training experience
  • not have any injury, disease or pain that could reduce their maximal effort

You may not qualify if:

  • history of injury to the lower limbs (including the hamstrings), wrist, or back in the past 18 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rodrigo Martin-San Agustin

Valencia, Spain

Location

MeSH Terms

Conditions

Athletic Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Rodrigo Martín-San Agustín

    University of Valencia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Physiotherapy

Study Record Dates

First Submitted

July 27, 2024

First Posted

August 5, 2024

Study Start

September 1, 2019

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

August 9, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations