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Chronic Effect of Individualized Core Stability Programs in Recreational Athletes.

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ClinicalTrials.gov Identifier: NCT03459430
Recruitment Status : Recruiting
First Posted : March 8, 2018
Last Update Posted : July 16, 2018
Sponsor:
Collaborator:
Ministerio de Economía y Competitividad, Spain
Information provided by (Responsible Party):
CASTO JUAN RECIO, Universidad Miguel Hernandez de Elche

February 19, 2018
March 8, 2018
July 16, 2018
March 10, 2018
September 8, 2018   (Final data collection date for primary outcome measure)
  • 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)
Same as current
Complete list of historical versions of study NCT03459430 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
  • Global dynamic balance in anterior direction [ Time Frame: Baseline - 6 weeks ]
    Anterior reaching distance during unipodal stance (units: centimeters)
  • Global dynamic balance in posteromedial direction [ Time Frame: Baseline - 6 weeks ]
    Posteromedial reaching distance during unipodal stance (units: centimeters)
  • Global dynamic balance in posterolateral direction [ Time Frame: Baseline - 6 weeks ]
    Posterolateral reaching distance during unipodal stance (units: centimeters)
  • 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)
  • 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)
  • 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)
  • 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)
  • Neuromuscular function of lower extremity [ Time Frame: Baseline - 6 weeks ]
    Triple hop test (Units: centimeters)
Same as current
 
Chronic Effect of Individualized Core Stability Programs in Recreational Athletes.
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.
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.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Core Stability
Other: Core stability training
Effect of different core stability programs using diverse training intensities
  • Experimental: Low Intensity training group
    Low Intensity training group will complete a 6 week core stability training program with low intensity/oscillation exercises
    Intervention: Other: Core stability training
  • Experimental: High Intensity training group
    High Intensity training group will complete a 6 week core stability training program with high intensity/oscillation exercises
    Intervention: Other: Core stability training
  • No Intervention: Control group
    Control group will have 6 weeks with no intervention before post-test
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
Same as current
December 31, 2018
September 8, 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
18 Years to 35 Years   (Adult)
Yes
Contact: Francisco J Vera-Garcia, Professor +34 966658875 ext 8875 fvera@umh.es
Contact: Casto Juan Recio, PhD +34 966652495 ext 2495 cjuan@umh.es
Spain
 
 
NCT03459430
2015/00116/001
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Yes
Plan Description: All Individual Participant Data (IPD) that underlie results in a publication.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Time Frame: Data will be available six months after publication
Access Criteria: Data access requests will be reviewed by an external Independent Review Panel. Requestors will be required to sign a Data Access Agreement
CASTO JUAN RECIO, Universidad Miguel Hernandez de Elche
CASTO JUAN RECIO
Ministerio de Economía y Competitividad, Spain
Principal Investigator: Francisco J Vera-Garcia, Professor Universidad Miguel Hernandez de Elche, Spain
Universidad Miguel Hernandez de Elche
July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP