- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03459430
Chronic Effect of Individualized Core Stability Programs in Recreational Athletes.
February 7, 2019 updated by: CASTO JUAN RECIO
The Effect of Core Stability Programs With Different Training Intensities Quantified Using Accelerometers Integrated in Smartphones: a Randomized Controlled Trial
Core stability (CS) training is nowadays largely used in several fields, mainly to enhance athletic performance and to prevent and rehabilitate musculoskeletal injuries.
However, in several experimental studies, CS training programs have not delivered as positive results as could be expected.
The lack of proper modulation and quantification of the training load parameters (such as intensity, volume, frequency, etc.) may be one of the main explanations.
Although training intensity has been manipulated by modifying the CS exercise difficulty through variations in mechanical constraints (i.e.
participant posture, lever arms, base of support, unstable surfaces, etc.), to the best of the authors' knowledge no experimental study has quantified the CS training intensity based on objective parameters.
The quantification of the load intensity is fundamental to analyze the dose-response relationships between training and CS adaptations.
Therefore, the main aim of this study is to evaluate the effectiveness of two individualized CS training programs using smartphone accelerometers placed on the pelvis to quantify the intensity of several of the most common CS exercises employed in fitness, sports and rehabilitation.
The expected effect is that the experimental groups will improve CS significantly.
Study Overview
Detailed Description
Sixty recreational male athletes will be evaluated twice (pre-test 1 and pre-test 2) before a core stability (CS) training program.
Testing sessions will consist in several tests to assess sitting and global dynamic postural control, trunk isometric endurance, neuromuscular function of the lower extremities, trunk response to sudden and unexpected load perturbations and pelvic oscillation during CS exercises evaluated with a smartphone accelerometer.
Later, they will be randomly assigned to one of the three groups included in the study: two experimental groups (low and high intensity) and a control group.
The intervention will have a training frequency of 2 days per week for 6 weeks.
Each CS training session will consist in 4 sets of one variation of four of the most popular stabilization exercises used to challenge core muscles: frontal bridge, back bridge, lateral bridge and bird-dog.
Exercise variations will be performed isometrically in increasing order of difficulty through the modifications of the following mechanical constraints: lever-arm, number of supports and/or the use of unstable surfaces.
The CS training programs will differ in exercises intensity, mainly.
Each participant of the low intensity group will perform those exercise variations in which they have obtained an oscillation ranged between 0.2 and 0.3 m/s2 in pre-test, while participants of the high intensity group will perform the exercise variations in which they have obtained an oscillation ranged between 0.4 and 0.5 m/s2.
The exercise duration will be set at 30 s and 15 s for the low intensity and high intensity group, respectively.
All participants of the training groups will be revaluated every two weeks during the training period.
After the intervention period, all participants will perform a post-test to evaluate the effectiveness of both CS programs.
Statistical analysis will consist in repeated-measures ANOVAs for detecting possible significant differences within and between-groups.
Study Type
Interventional
Enrollment (Actual)
60
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
-
-
Alicante
-
Elche, Alicante, Spain, 03202
- Sport Research Center
-
-
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 35 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Healthy recreative male athletes between 18 and 35 years old
Exclusion Criteria:
- Inguinal hernia or urinary incontinence
- Pathologies that contraindicate physical exercise practice
- Low back pain in the last six months prior to testing
- Pathologies related with Central Nervous System that affect balance
- Professional athletes of sports modalities with high core stability demands
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: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Low Intensity training group
Low Intensity training group will complete a 6 week core stability training program with low intensity/oscillation exercises
|
Effect of different core stability programs using diverse training intensities
|
|
EXPERIMENTAL: High Intensity training group
High Intensity training group will complete a 6 week core stability training program with high intensity/oscillation exercises
|
Effect of different core stability programs using diverse training intensities
|
|
NO_INTERVENTION: Control group
Control group will have 6 weeks with no intervention before post-test
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean radial error of center of pressure in sitting condition
Time Frame: Baseline - 6 weeks
|
Postural control in sitting condition over an unstable seat evaluated through the mean radial error of center of pressure displacement (Units: millimeters)
|
Baseline - 6 weeks
|
|
Trunk angular displacement
Time Frame: Baseline - 6 weeks
|
Trunk angular displacement after sudden loading perturbations in different planes of motion (units: degrees)
|
Baseline - 6 weeks
|
|
Pelvis mean acceleration
Time Frame: Baseline - every 2 weeks up to 6 weeks
|
Pelvis mean acceleration in different isometric stabilization exercises measured with a smartphone accelerometer (Units: m/s2)
|
Baseline - every 2 weeks up to 6 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Global dynamic balance in anterior direction
Time Frame: Baseline - 6 weeks
|
Anterior reaching distance during unipodal stance (units: centimeters)
|
Baseline - 6 weeks
|
|
Global dynamic balance in posteromedial direction
Time Frame: Baseline - 6 weeks
|
Posteromedial reaching distance during unipodal stance (units: centimeters)
|
Baseline - 6 weeks
|
|
Global dynamic balance in posterolateral direction
Time Frame: Baseline - 6 weeks
|
Posterolateral reaching distance during unipodal stance (units: centimeters)
|
Baseline - 6 weeks
|
|
Mean radial error of center of pressure in upright tandem stance
Time Frame: Baseline - 6 weeks
|
Postural control in upright tandem stance condition evaluated through the mean radial error of center of pressure displacement (Units: millimeters)
|
Baseline - 6 weeks
|
|
Trunk extensors isometric endurance
Time Frame: Baseline - 6 weeks
|
Time to maintain a particular position against gravity until exhaustion using Biering-Sorensen test; (Units: seconds)
|
Baseline - 6 weeks
|
|
Trunk flexors isometric endurance
Time Frame: Baseline - 6 weeks
|
Time to maintain a particular position against gravity until exhaustion using using Plank test; (Units: seconds)
|
Baseline - 6 weeks
|
|
Trunk lateral flexors isometric endurance
Time Frame: Baseline - 6 weeks
|
Time to maintain a particular position against gravity until exhaustion using Side Bridge test; (Units: seconds)
|
Baseline - 6 weeks
|
|
Neuromuscular function of lower extremity
Time Frame: Baseline - 6 weeks
|
Triple hop test (Units: centimeters)
|
Baseline - 6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Francisco J Vera-Garcia, Professor, Universidad Miguel Hernandez de Elche, Spain
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 (ACTUAL)
March 10, 2018
Primary Completion (ACTUAL)
December 21, 2018
Study Completion (ACTUAL)
December 21, 2018
Study Registration Dates
First Submitted
February 19, 2018
First Submitted That Met QC Criteria
March 1, 2018
First Posted (ACTUAL)
March 8, 2018
Study Record Updates
Last Update Posted (ACTUAL)
February 8, 2019
Last Update Submitted That Met QC Criteria
February 7, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- 2015/00116/001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
All Individual Participant Data (IPD) that underlie results in a publication.
IPD Sharing Time Frame
Data will be available six months after publication
IPD Sharing Access Criteria
Data access requests will be reviewed by an external Independent Review Panel.
Requestors will be required to sign a Data Access Agreement
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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