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Trial registered on ANZCTR
Registration number
ACTRN12624000202561
Ethics application status
Approved
Date submitted
24/10/2023
Date registered
29/02/2024
Date last updated
29/02/2024
Date data sharing statement initially provided
29/02/2024
Type of registration
Retrospectively registered
Titles & IDs
Public title
Comparison of two different stretching strategies on hip extension mobility in healthy and active adults: a randomized clinical trial.
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Scientific title
Comparison of the effects of conventional and posterior pelvic tilt stretching on reactive hip flexor force in healthy and active adults: a randomized controlled trial
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Secondary ID [1]
311224
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hip flexors muscle stiffness
331850
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Condition category
Condition code
Musculoskeletal
328593
328593
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0
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Normal musculoskeletal and cartilage development and function
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
A stretch with a lower extremity was analyzed by an expert physiotherapist. This stretch was performed in conventional hip extension, in a half-knee position, but adding a posterior pelvic tilt position (posterior pelvic tilt group). Stretching was performed in two sets of 30 seconds with 30 seconds of rest between sets, performed individually for each subject (one-on-one) at the research center. Intervention throughout the study.
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Intervention code [1]
327248
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Rehabilitation
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Comparator / control treatment
A stretch with a lower extremity was analyzed by an expert physiotherapist; this stretch was performed in conventional hip extension, in a half-knee position (hip extension group). Stretching was performed in two sets of 30 seconds with 30 seconds of rest between sets, performed individually for each subject (one-on-one) at the research center.
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Control group
Active
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Outcomes
Primary outcome [1]
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The reactive peak force (RHF)
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Assessment method [1]
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The RHF Test was administered with the participant lying in a supine position on an examination table, their arms parallel to the body, and one lower extremity positioned with the hip flexed at 90 degrees and the knee bent, while the other lower extremity remained in a neutral position with the knee and hip fully extended.
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Timepoint [1]
336394
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Baseline (pre-stretching/intervention) and immediately post-stretching/intervention
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Secondary outcome [1]
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Active Knee Extension (AKE)
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Assessment method [1]
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Active Knee Extension (AKE) in degrees for the contralateral lower limb at 90 degrees of hip flexion was assessed using a standard universal goniometer (Orthopedic Equipment Co., Bourbon, USA). AKE measurement involved determining the degrees of knee extension from the point of full knee flexion, as indicated in previous studies
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Timepoint [1]
428148
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Immediatelly post stretching
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Eligibility
Key inclusion criteria
The inclusion criteria for this study were male and females individuals, aged between 18 and 35 years, and who maintained a training regimen of at least two days per week.
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Minimum age
18
Years
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Maximum age
35
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Exclusion criteria were individuals with a history of musculoskeletal lower limb or lumbopelvic conditions within the last five years, as well as those with neuromuscular, rheumatic, cardiovascular or neurological diseases, and those who had undergone previous surgical interventions or experienced fractures in the lower extremities or abdominal region.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
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Actual
21/09/2023
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Date of last participant enrolment
Anticipated
22/03/2024
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Actual
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Date of last data collection
Anticipated
25/04/2024
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Actual
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Sample size
Target
34
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Accrual to date
16
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Final
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Recruitment outside Australia
Country [1]
25918
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Spain
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State/province [1]
25918
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Madrid
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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University European of Madrid
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Address [1]
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University European of Madrid, UEM. Calle Tajo s/n, Villaviciosa de Odón, Madrid, Spain
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Country [1]
315085
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Spain
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Primary sponsor type
University
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Name
University European of Madrid
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Address
University European of Madrid, UEM. Calle Tajo s/n, Villaviciosa de Odón, Madrid, Spain
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Country
Spain
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Secondary sponsor category [1]
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None
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Name [1]
317107
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Address [1]
317107
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Country [1]
317107
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Ethics Committee of the European University of Madrid
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Ethics committee address [1]
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Universidad Europea de Madrid. Calle Tajo S/n, Villaviciosa de Odón, Madrid, 28670, Spain.
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Ethics committee country [1]
314033
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Spain
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Date submitted for ethics approval [1]
314033
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01/06/2022
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Approval date [1]
314033
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29/07/2022
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Ethics approval number [1]
314033
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Summary
Brief summary
Achieving optimal hip extension mobility and hamstring flexibility is crucial for overall musculoskeletal health and functional movement. Limited hip extension can impact daily activities and athletic performance, while inadequate hamstring flexibility is associated with an increased risk of injury. As such, investigating effective stretching techniques to enhance hip extension and hamstring flexibility is of paramount importance. This study aims to contribute valuable insights into the comparative effectiveness of posterior pelvic tilt and hip extension stretches, with the anticipation that one of these techniques may prove superior in promoting improved hip extension and hamstring flexibility. The primary objective of this study is to compare the effects of two stretching techniques, posterior pelvic tilt and hip extension, on enhancing hip extension mobility and hamstring flexibility. We hypothesize that the posterior pelvic tilt technique will yield greater improvements in hip extension mobility and hamstring flexibility compared to the hip extension technique.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Diego Domínguez-Balmaseda
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Address
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Universidad Europea de Madrid. Calle Tajo S/n, Villaviciosa de Odón, Madrid, 28670, Spain.
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Country
130186
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Spain
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Phone
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+0034 617745364
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Guillermo García de Sevilla Perez
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Address
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Universidad Europea de Madrid. Calle Tajo S/n, Villaviciosa de Odón, Madrid, 28670, Spain.
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Country
130187
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Spain
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Phone
130187
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+0034 654345367
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Fax
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Email
130187
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[email protected]
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Contact person for scientific queries
Name
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Angel Gonzalez de la Flor
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Address
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Universidad Europea de Madrid. Calle Tajo S/n, Villaviciosa de Odón, Madrid, 28670, Spain.
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Country
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Spain
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Phone
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+0034 624536253
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Fax
130188
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Email
130188
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
20728
Informed consent form
[email protected]
386782-(Uploaded-24-10-2023-02-46-54)-Study-related document.docx
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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