- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04450615
Core Exercises Effects on Muscle Imbalances
Effects of a 5-week Core Training Program on Core Muscles' Imbalances
Study Overview
Status
Intervention / Treatment
Detailed Description
A total of 136 male and female adults, members of local gyms, were initially invited for participation in the study after giving their written consent. After a second contact with the participants, forms regarding the inclusion and exclusion criteria were sent for completion.
Of the 136 that initially answered positively for participation, 62 did not meet the inclusion criteria, based on their reports and the clinical examination by a health professional. Of the remaining 74 participants, 32 were excluded because of previous low back pain incidents and other recent musculoskeletal injuries that led to rehabilitation, while 22 decided to not participate for personal reasons.
The remaining 20 participants were randomly allocated to either training group or intervention group, by a neutral, blinded investigator who had no involvement and was unaware of the study purposes. The intervention group will be trained and supervised by a certified fitness instructor in a gym class, who will be responsible for the correct execution of the exercises. The duration of the intervention will be 5 weeks, 3 times a week.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Serres, Greece, 62110
- Laboratory of Neuromechanics, Department of physical education and sport sciences, Aristotle University of Thessaloniki
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 18 to 45 years old
- Trained recreationally at least 2 times a week, for the past 3 years
- Healthy
- No musculoskeletal injuries in the 6 months prior to the study
Exclusion Criteria:
- History of chronic low back pain
- History of hip, pelvic or low back surgery
- History of acute low back pain with duration at least 1 week, the preceding 6 months
- Involvement in similar core stability training programs the last 12 moths prior to this study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Training group
The first part of the program aims in pelvic and hip mobility and includes the following exercises, glute bridge, single-leg glute bridge, side-lying clam, side plank and side plank with hip abduction, on stable surface. The second part consists of exercises for deep and superficial trunk muscles. In the first exercise the participants learn to activate the transversus abdominis muscle from the crook-lying position, by performing abdominal hollow. Other exercises include the front plank, trunk curl-up, trunk curl-up on stable surface and curl-up on unstable surface (Swiss ball). The third part of the program consists of exercises for strengthening the lumbar multifidus muscle. The participants will perform prone trunk extension, superman exercise, quadruped diagonal arm and leg lift, single leg supine bridge and supine bridge on unstable surface (Swiss ball). |
The exercise protocol consists of the following sets and repetitions, with a total duration of 5 weeks and a frequency of 3 sessions per week. Dynamic exercises: 2 sets of 10 to 15 repetitions (each side) Isometric exercises: 2 sets of 5 to 15 seconds (each side) Week 1- As mentioned above Week 2- Add 1 set Week 3 - Add 5 seconds and 5 repetitions Week 4 - Add 1 set Week 5- Add 5 seconds and 5 repetitions |
No Intervention: Control group
The participants of this group will follow their typical daily routine
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Transversus abdominis (TrA) muscle thickness at rest and contraction
Time Frame: Change from baseline assessment at 5 weeks
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Muscle thickness (mm) is measured using ultrasonography
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Change from baseline assessment at 5 weeks
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Lumbar multifidus (LM) muscle thickness at rest and contraction
Time Frame: Change from baseline assessment at 5 weeks
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Muscle thickness (mm) is measured using ultrasonography
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Change from baseline assessment at 5 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Contraction thickness ratio (CTR) of TrA and LM muscle
Time Frame: Change from baseline assessment at 5 weeks
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This is calculated by subtracting rest thickness from contraction thickness, dividing it to rest thickness and multiplying this value by 100 [(contraction thickness-rest thickness/rest thickness)*100]
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Change from baseline assessment at 5 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Athanasios Ellinoudis, PhD, Laboratory of Neuromechanics, Aristotle University of Thessaloniki
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ERC-006/2020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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