Trial Review

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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.
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
Secondary ID [1] 311224 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hip flexors muscle stiffness 331850 0
Condition category
Condition code
Musculoskeletal 328593 328593 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 327248 0
Rehabilitation
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.
Control group
Active

Outcomes
Primary outcome [1] 336394 0
The reactive peak force (RHF)
Timepoint [1] 336394 0
Baseline (pre-stretching/intervention) and immediately post-stretching/intervention
Secondary outcome [1] 428148 0
Active Knee Extension (AKE)
Timepoint [1] 428148 0
Immediatelly post stretching

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.
Minimum age
18 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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.


Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
21/09/2023
Date of last participant enrolment
Anticipated
22/03/2024
Actual
Date of last data collection
Anticipated
25/04/2024
Actual
Sample size
Target
34
Accrual to date
16
Final
Recruitment outside Australia
Country [1] 25918 0
Spain
State/province [1] 25918 0
Madrid

Funding & Sponsors
Funding source category [1] 315085 0
University
Name [1] 315085 0
University European of Madrid
Country [1] 315085 0
Spain
Primary sponsor type
University
Name
University European of Madrid
Address
University European of Madrid, UEM. Calle Tajo s/n, Villaviciosa de Odón, Madrid, Spain
Country
Spain
Secondary sponsor category [1] 317107 0
None
Name [1] 317107 0
Address [1] 317107 0
Country [1] 317107 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314033 0
Ethics Committee of the European University of Madrid
Ethics committee address [1] 314033 0
Ethics committee country [1] 314033 0
Spain
Date submitted for ethics approval [1] 314033 0
01/06/2022
Approval date [1] 314033 0
29/07/2022
Ethics approval number [1] 314033 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 130186 0
Dr Diego Domínguez-Balmaseda
Address 130186 0
Universidad Europea de Madrid. Calle Tajo S/n, Villaviciosa de Odón, Madrid, 28670, Spain.
Country 130186 0
Spain
Phone 130186 0
+0034 617745364
Fax 130186 0
Email 130186 0
diego.dominguez@universidadeuropea.es
Contact person for public queries
Name 130187 0
Guillermo García de Sevilla Perez
Address 130187 0
Universidad Europea de Madrid. Calle Tajo S/n, Villaviciosa de Odón, Madrid, 28670, Spain.
Country 130187 0
Spain
Phone 130187 0
+0034 654345367
Fax 130187 0
Email 130187 0
guillermo.garcia@universidadeuropea.es
Contact person for scientific queries
Name 130188 0
Angel Gonzalez de la Flor
Address 130188 0
Universidad Europea de Madrid. Calle Tajo S/n, Villaviciosa de Odón, Madrid, 28670, Spain.
Country 130188 0
Spain
Phone 130188 0
+0034 624536253
Fax 130188 0
Email 130188 0
angel.gonzalez@univerisdadeuropea.es

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
20728Informed consent form  angel.gonzalez@universidadeuropea.es 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.