- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01841216
EMG Activation of Gluteal Musculature During Exercises With and Without Resistance (GlutEMG02)
January 30, 2015 updated by: Sport and Spine Rehab Clinical Research Foundation
EMG Activation of Gluteal Musculature and Perceived Exertion During Therapeutic Exercises With and Without Thera-Band® Resistance
The gluteus medius (Gmed) and gluteus maximus (Gmax) muscles are important components in the treatment of many lower limb injuries.
Recent studies have evaluated a myriad of exercises which activate the Gmed and Gmax, but limited research remains on exercises involving resistance and the role of the TFL.
The purpose of this study is to evaluate Gmed, Gmax, and TFL percent maximal voluntary isometric contraction (%MVIC) and perceived exertion in healthy and low back pain patients while performing exercises with and without resistance.
Methods: A convenience sample of healthy subjects and patients diagnosed with non-radicular low back pain will be recruited.
Exclusionary criteria will include: current low back or lower extremity injury (healthy group), pregnancy, history of hip surgery, and radicular symptoms.
Surface electromyography will be used to quantify the activity level of the gluteal muscles and TFL while performing a series of 8 exercises with and without Thera-Band® Resistance Tubing and Stability Trainer.
The maximal voluntary isometric contraction (MVIC) will be established for each muscle group and the order of exercises performed will be randomized to minimize the effect of fatigue.
Following the completion of each exercise, the patient will rate their perceived exertion level on the Thera-Band® Resistance Intensity Scale for Exercise (RISE).
The EMG signals will be smoothed and rectified and analyzed using a root-mean-square algorithm.
Clinical Relevance: The results of this study will allow clinicians to better prescribe exercises, proven to activate the gluteal muscles and limit the TFL involvement, in the treatment of low back pain.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30
Phase
- 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
-
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Maryland
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Rockville, Maryland, United States, 20852
- Sport & Spine Rehab
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-
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
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- healthy, physically active subjects
- patients diagnosed with non-radicular low back pain
- 18-65
Exclusion Criteria:
- current low back or lower extremity injury (healthy group)
- pregnancy
- history of hip surgery
- radicular symptoms
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: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Low Back Pain
Lower Body Exercises with and without resistance
|
lower body exercises with and without resistance designed to activate the gluteal/hip musculature
|
Experimental: Healthy
Lower Body Exercises with and without resistance
|
lower body exercises with and without resistance designed to activate the gluteal/hip musculature
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent of Maximal Voluntary Isometric Contraction (%MVIC)
Time Frame: One 40 minute session
|
Percent of Maximal Voluntary Isometric Contraction was measured by placing EMG leads on selected muscles.
Data was collected and analyzed with the MyoResearch XP Masters Edition (Noraxam Inc., Scottsdale, AZ).
The EMG signals were smoothed and rectified and analyzed using a root-mean-square algorithm.
We used visual onset and offset of the EMG signal amplitude to select the middle 3 of 5 trials.
The middle three repetitions were analyzed.
Average activation and peak activation were determined and then compared to the maximum voluntary isometric contraction (MVIC), captured during a manual muscle test, for each muscle group, and expressed as a %MVIC.
The %MVIC can be greater than 100% since the MVIC is captured in a stationary, isometric position using manual force and all other activities are performed in motion against elastic or gravity resistance.
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One 40 minute session
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perceived Exertion
Time Frame: 16 exercises during one 40 minute session
|
Thera-Band(R) RISE (Resistance Intensity Scale for Exercise) Scale to measure amount of perceived exertion during resistance band exercises.
This is a scale 0 to 10, 0 being extremely easy and 10 being extremely hard.
The subject rated the intensity or resistance felt on each exercise on this scale.
The ideal range for an exercise is in the middle of the scale (4-7) where the subject is feeling resistance but is not maximally exerted.
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16 exercises during one 40 minute session
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Barton Bishop, DPT, Sport & Spine Rehab Clinical Research Foundation
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
April 1, 2013
Primary Completion (Actual)
December 1, 2013
Study Completion (Actual)
December 1, 2013
Study Registration Dates
First Submitted
April 23, 2013
First Submitted That Met QC Criteria
April 23, 2013
First Posted (Estimate)
April 26, 2013
Study Record Updates
Last Update Posted (Estimate)
February 3, 2015
Last Update Submitted That Met QC Criteria
January 30, 2015
Last Verified
January 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SSR02
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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