Comparison of Architectural and Performance Adaptations of Hip Extension Exercise Under Gravitational or Inertial Loading Conditions

August 5, 2024 updated by: Rodrigo Martín-San-Agustin, University of Valencia
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Spain
      • Valencia, Spain
        • Rodrigo Martin-San Agustin

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Gravitational
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
Hip extension exercise with gravitational load
No Intervention: Control
Participans was advised to continue their regular levels of physical activity but not to perform any lower body resistance training
Experimental: Inertial
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
Hip extension exercise with inertial load

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Muscle Strength Assessment
Time Frame: Baseline, at the end of the 6 weeks of training and 4 weeks after this (detraining period)
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
Time Frame: Baseline, at the end of the 6 weeks of training and 4 weeks after this (detraining period)
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
Time Frame: Baseline, at the end of the 6 weeks of training and 4 weeks after this (detraining period)
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
Time Frame: From session 1 (the beginning of week 1) to session 12 (the end of week 6), at the beginning and end of each session.
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.
Fascicle length
Time Frame: 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)

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)

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Valencia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Rodrigo Martín-San Agustín, University of Valencia

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 27, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 31, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 5, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 9, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 5, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H1551979435533

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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