NCT04301947

Brief Summary

Gluteal activation warm-up is one of the modalities being investigated recently. Although widely used in clinical and sports practice, it is unclear whether, in fact, performing gluteal activation exercises in warm-up is effective in increasing electromyographic activation (EMG), as well as the mechanisms that explain eventual gluteal activation improvement of neuromuscular function. Thus, the aim of this study is to verify the acute effect of a gluteal activation warm-up protocol on gluteus maximus (superior fibers) and gluteus medius EMG activation and kinematics during single leg squat. The hypotheses of this study are that after a gluteal activation warm-up program, there will be an increase in the muscle recruitment (mean) levels of the gluteus maximus (superior fibers) and gluteus medium. About kinematics, the hypotheses is that a decrease on hip adduction absolute angle and hip and knee frontal plane ROM on maximum knee flexion during single leg squat will occur. Physically active adults from 18 to 35 years old, with no history of previous injury or surgery on the lower limbs, who present excessive hip adduction during single-leg squat on the dominant limb in previous evaluation via visual scoring scale will participate in this study. The design adopted will be performed in the following order: (1) Preparation and familiarization. (2) Intervention protocol (standard warm-up protocol or the gluteal activation warm-up protocol), (4) immediately after the intervention protocol, the subjects will perform 3 single-leg squats and (5) EMG and MIVC strength test. The standard warm-up consist 5 minutes on a stationary bike and 30 seconds calf, hamstrings and quadriceps stretch. The gluteal activation warm-up protocol consists of performing the standard warm-up protocol and 3 sets of 12 repetitions clam exercise, using a elastic band (Perform Better®, USA). Exertion perception will be controlled using an exertion perception scale (OMNI). From kinematic and EMG data, absolute values of the hip adduction, hip and knee ROM in the frontal plane of the dominant limb and mean EMG activation data from the gluteus maximus (superior fibers) and gluteus medius muscles we will extracted, respectively. All data will be analyzed using descriptive and inferential statistics. (p \<0.05).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2020

Shorter than P25 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

First Submitted

Initial submission to the registry

February 5, 2020

Completed
25 days until next milestone

Study Start

First participant enrolled

March 1, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 10, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

January 22, 2021

Status Verified

January 1, 2021

Enrollment Period

9 months

First QC Date

February 5, 2020

Last Update Submit

January 21, 2021

Conditions

Keywords

single leg squat2D kinematicship adductionEMGgluteal activationwarm-up

Outcome Measures

Primary Outcomes (4)

  • Pre standard warm-up protocol hip adduction

    Absolute angle of hip adduction at peak knee flexion during squat leg squat, expressed in degrees (º).

    two minutes before the intervention

  • Post standard warm-up protocol hip adduction

    Absolute angle of hip adduction at peak knee flexion during squat leg squat, expressed in degrees (º).

    two minutes after the intervention

  • Pre gluteal activation warm-up protocol hip adduction

    Absolute angle of hip adduction at peak knee flexion during squat leg squat, expressed in degrees (º).

    two minutes before the intervention

  • Post gluteal activation warm-up protocol hip adduction

    Absolute angle of hip adduction at peak knee flexion during squat leg squat, expressed in degrees (º).

    two minutes after the intervention

Secondary Outcomes (4)

  • Pre standard warm-up protocol gluteus maximus and medius EMG activity.

    two minutes before the intervention

  • Post standard warm-up protocol gluteus maximus and medius EMG activity

    two minutes after the intervention

  • Pre gluteal activation warm-up protocol gluteus maximus and medius EMG activity.

    two minutes before the intervention

  • Post gluteal activation warm-up protocol gluteus maximus and medius EMG activity.

    two minutes after the intervention

Other Outcomes (4)

  • Pre standard warm-up protocol hip and knee adduction/abduction and knee flexion range of motion

    two minutes before the intervention

  • Post standard warm-up protocol hip and knee adduction/abduction and knee flexion range of motion

    two minutes after the intervention

  • Pre gluteal activation warm-up protocol hip and knee adduction/abduction and knee flexion range of motion

    two minutes before the intervention

  • +1 more other outcomes

Study Arms (2)

Standard warm-up protocol

ACTIVE COMPARATOR

The standard warm-up protocol consists of 5 (five) minutes of stationary cycling, followed by calf, hamstring and quadriceps stretching. For all stretching positions 30 (thirty) seconds will be set. For calf stretching, the participant places his hands on the waist and projects his dominant limb behind of the center of mass line, the contralateral limb will be placed forward until the stretch sensation on the dominant limb start. For hamstring stretching, the participant will be instructed to bend over the hip, reaching the foot of the dominant limb in dorsiflexion. Emphasis will be placed on maintaining the heel of the dominant limb on the floor and maintaining posture. Finally, for quadriceps stretching, the participant will perform a knee flexion and will hold the dominant lower limb foot close to the gluteus with the ipsilateral upper limb hand. Emphasis will be placed on maintaining trunk posture.

Other: Standard warm-up protocol

Gluteal activation warm-up

EXPERIMENTAL

The gluteal activation warm-up protocol consists of performing a standard warm-up protocol with additional "shell" exercise. The shell exercise will be performed with the participant side-lying with hip and knee flexed, an elastic band (PREFORM BETTER Inc. Rhode Island, USA) will be placed around the distal thigh to promote resistance and the participants will be instructed to perform hip abduction movements. The exercise will be performed in multiple sets (3 sets) of 12 repetitions, with 30 seconds interval between exercises in order to minimize the fatigue effect. Medium and heavy elastic bands tensions will be used and adjusted according to the effort perception parameter from the OMNI scale for effort perception for resistance training.

Other: Gluteal activation warm-up protocol

Interventions

Stationary cycling and lower limb stretching exercises

Standard warm-up protocol

Standard warm-up protocol + Clam exercise (3 sets of 12 repetitions each)

Gluteal activation warm-up

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age: between 18 and 35 years old.
  • Physically active: regularly participating in activities of training sessions 3x/week and minimum 20 minutes duration for each session.
  • No complaints about pain or musculoskeletal impairment on dominant leg during the first contact/interview.
  • Pelvic drop presentation during single leg squat on dominant leg: Will be included only those participants who, on the first interview, present excessive hip adduction during the single-leg squat task detected by visual assessment screening.

You may not qualify if:

  • History of recent upper limb or spine injury.
  • Surgery on dominant limb or time less than one year of surgery on non dominant limb.
  • Complaints about cardiovascular or systemic diseases that could limit performance of the tests.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of the State of Santa Catarina (UDESC)

Florianópolis, Santa Catarina, 88080-350, Brazil

Location

Study Officials

  • CAROLINE RUSCHEL, PE PhD

    University of the State of Santa Catarina

    STUDY CHAIR
  • MARCELO P CASTRO, PT PhD

    Neuromusculoskeletal Rehab. and Clinical Biomechanics Laboratory - LaBClin

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
All participants enrolled will receive instructions about the protocols by the same investigator. An independent researcher will perform block randomization, with a 1:1 allocation ratio and allocation order (using the random list generator at www.randomization.com). The results will be stored in sequentially numbered opaque sealed envelopes that will be opened before the first intervention in the presence of the participant. An independent investigator will code the data and make it available to the investigator who applied the intervention after a wash-out period for processing. The processed data will be sent to this independent researcher, who will decode it and perform the statistical analysis.
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: This is a descriptive quantitative study with cross-over design of repeated measures.The study will be conducted in two stages. In the first stage, anthropometric data collection, intervention protocol application and biomechanical data collection will be performed. The intervention application order will be random and counterbalanced which half of the participants will receive the gluteal pre-activation protocol and the other half a standard warm-up protocol at the first visit. In the second stage, the intervention will be applied and biomechanical data will be collected. In this context, the following routine will be performed: (1) Preparation and familiarization (2) intervention protocol application (standard warm-up or gluteal pre-activation) (3) Immediately after the protocol, three (3) repetitions of the single-legged squat will be performed and (4) data collection of maximal voluntary isometric contraction will be extracted.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Ruschel, Caroline

Study Record Dates

First Submitted

February 5, 2020

First Posted

March 10, 2020

Study Start

March 1, 2020

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

January 22, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will share

authors declare that deidentified IPD that underlie the results in the publication, Study Protocol and Statistical Analysis Plan will be shared immediately following publication and ending three years after publication with investigators that intend to use data for research purposes, as approved by an independent review committee. Requests should be addressed to caroline.ruschel@udesc.br accompanied by the approved proposal.

Shared Documents
SAP
Time Frame
Immediately following publication and ending three years after publication.
Access Criteria
Investigators whose intention is to use the data for research purposes as approved by an independent review committee should direct the approved proposal to caroline.ruschel@udesc.br to request access.

Locations