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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Spain
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Low Intensity training group
Low Intensity training group will complete a 6 week core stability training program with low intensity/oscillation exercises
Other: Core stability training
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
Other: Core stability training
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
CASTO JUAN RECIO

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ministerio de Economía y Competitividad, Spain

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 10, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 21, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 21, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 19, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 1, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 8, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 8, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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