Injury;SportsNCT06538467
Comparison of Architectural and Performance Adaptations of Hip Extension Exercise Under Gravitational or Inertial Loading Conditions
A study testing Hip extension exercise with inertial load and Hip extension exercise with gravitational load in people with Injury;Sports, run by University of Valencia at 1 site in Spain.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Injury;Sports
- What is being tested?
- Hip extension exercise with inertial load and Hip extension exercise with gravitational load
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2019to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- at least two years of resistance training experience
- not have any injury, disease or pain that could reduce their maximal effort
Who cannot join
- history of injury to the lower limbs (including the hamstrings), wrist, or back in the past 18 months
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Injury;Sports
- Being tested
- Hip extension exercise with inertial load, Hip extension exercise with gravitational load
- Medical subject headings
- Athletic Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hip extension exercise with inertial loadOther
Hip extension exercise with inertial load
Hip extension exercise with gravitational loadOther
Hip extension exercise with gravitational load
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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))
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: From session 1 (the beginning of week 1) to session 12 (the end of week 6), at the beginning and end of each session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2024
- Study start1 Sep 2019
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Injury;SportsStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rodrigo Martín-San-Agustin, University of Valencia
- Investigators
- Rodrigo Martín-San Agustín, Principal investigator, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06538467
- Sponsor's protocol ID
- H1551979435533
- Status last verified
- Aug 2024
- First submitted
- 27 Jul 2024
- Last updated
- 9 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Architectural and Performance Adaptations of Hip Extension Exercise Under Gravitational or Inertial Loading Conditions
- ClinicalTrials.gov ID
- NCT06538467
- Acronym / sponsor ID
- H1551979435533
- Conditions
- Injury;Sports
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 5 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Inertial | Experimental | Other: Hip extension exercise with inertial loadHip 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. |
| Gravitational | Experimental | Other: Hip extension exercise with gravitational loadHip extension exercise performed under gravitational loading conditions using free-weight equipment during six weeks with two sessions per week. |
| Control | No intervention | –Participans was advised to continue their regular levels of physical activity but not to perform any lower body resistance training |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- at least two years of resistance training experience
- not have any injury, disease or pain that could reduce their maximal effort
Key exclusion criteria (1 listed)
- history of injury to the lower limbs (including the hamstrings), wrist, or back in the past 18 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hip extension exercise with inertial loadHip extension exercise with inertial load | Other | Inertial |
| Hip extension exercise with gravitational loadHip extension exercise with gravitational load | Other | Gravitational |
Primary outcome
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))
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.
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.
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.
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rodrigo Martín-San Agustín principal investigator
University of Valencia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hip extension exercise with inertial load and Hip extension exercise with gravitational load in people with Injury;Sports, run by University of Valencia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.