Core StabilityNCT03459430
Chronic Effect of Individualized Core Stability Programs in Recreational Athletes.
A study testing Core stability training in people with Core Stability, run by CASTO JUAN RECIO at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Core Stability
- What is being tested?
- Core stability training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 10 Mar 2018to 21 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy recreative male athletes between 18 and 35 years old
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Core Stability
- Being tested
- Core stability training
- Keywords
- trunk stability, accelerometer, smartphone, core training, isometric exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Core stability trainingOther
Effect of different core stability programs using diverse training intensities
| Study group | Role | What they receive |
|---|---|---|
| Low Intensity training group | Experimental | Low Intensity training group will complete a 6 week core stability training program with low intensity/oscillation exercises Receives: Other: Core stability training |
| High Intensity training group | Experimental | High Intensity training group will complete a 6 week core stability training program with high intensity/oscillation exercises Receives: Other: Core stability training |
| Control group | No intervention | Control group will have 6 weeks with no intervention before post-test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean radial error of center of pressure in sitting condition
Postural control in sitting condition over an unstable seat evaluated through the mean radial error of center of pressure displacement (Units: millimeters)
Measured: Baseline - 6 weeks
Trunk angular displacement
Trunk angular displacement after sudden loading perturbations in different planes of motion (units: degrees)
Measured: Baseline - 6 weeks
Pelvis mean acceleration
Pelvis mean acceleration in different isometric stabilization exercises measured with a smartphone accelerometer (Units: m/s2)
Measured: Baseline - every 2 weeks up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2018
- Study start10 Mar 2018
- Primary completion21 Dec 2018
- Study completion21 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Core StabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- CASTO JUAN RECIO
- Sponsor type
- University, hospital or other
- Collaborators
- Ministerio de Economía y Competitividad, Spain
- Responsible party
- Sponsor-investigator, CASTO JUAN RECIO, Universidad Miguel Hernandez de Elche
- Investigators
- Francisco J Vera-Garcia, Professor, Principal investigator, Universidad Miguel Hernandez de Elche, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03459430
- Sponsor's protocol ID
- 2015/00116/001
- Other IDs
- 2015
- Status last verified
- Feb 2019
- First submitted
- 19 Feb 2018
- Last updated
- 8 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All Individual Participant Data (IPD) that underlie results in a publication.
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Core Stability Programs With Different Training Intensities Quantified Using Accelerometers Integrated in Smartphones: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03459430
- Acronym / sponsor ID
- 2015/00116/001
- Conditions
- Core Stability
- Keywords
- trunk stability, accelerometer, smartphone, core training, isometric exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- CASTO JUAN RECIOUniversity, hospital or other
- Collaborators
- Ministerio de Economía y Competitividad, Spain
- Study start
- 10 Mar 2018 (actual)
- Primary completion
- 21 Dec 2018 (actual)
- Study completion
- 21 Dec 2018 (actual)
- First posted
- 8 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low Intensity training group | Experimental | Other: Core stability trainingLow Intensity training group will complete a 6 week core stability training program with low intensity/oscillation exercises |
| High Intensity training group | Experimental | Other: Core stability trainingHigh Intensity training group will complete a 6 week core stability training program with high intensity/oscillation exercises |
| Control group | No intervention | –Control group will have 6 weeks with no intervention before post-test |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy recreative male athletes between 18 and 35 years old
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Core stability trainingEffect of different core stability programs using diverse training intensities | Other | High Intensity training group, Low Intensity training group |
Primary outcome
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)
Trunk angular displacement
Time frame: Baseline - 6 weeks
Trunk angular displacement after sudden loading perturbations in different planes of motion (units: degrees)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2019.
- Individual participant dataSharing planned: Yes. All Individual Participant Data (IPD) that underlie results in a publication.
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Effects of Dead Bug Exercises With and Without Diaphragmatic Breathing in Patients With Chronic Non-specific Low Back Pain.
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The Effects of Synchronous and Asynchronous Pilates Training Based on Telerehabilitation on Core Stabilization, Balance, Cognitive Functions, and Quality of Life in Individuals With Multiple Sclerosis: A Single-Blind Randomized Controlled Trial
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Enrolling by invitation
Online-Delivered Core Stability Exercises in Postpartum Women
Postpartum, Trunk Muscle Endurance
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francisco J Vera-Garcia, Professor principal investigator
Universidad Miguel Hernandez de Elche, Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Core stability training in people with Core Stability, run by CASTO JUAN RECIO at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean radial error of center of pressure in sitting condition (time frame: Baseline - 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2019.