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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03459430
Other study ID # 2015/00116/001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 10, 2018
Est. completion date December 21, 2018

Study information

Verified date February 2019
Source Universidad Miguel Hernandez de Elche
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date December 21, 2018
Est. primary completion date December 21, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 35 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Core stability training
Effect of different core stability programs using diverse training intensities

Locations

Country Name City State
Spain Sport Research Center Elche Alicante

Sponsors (2)

Lead Sponsor Collaborator
CASTO JUAN RECIO Ministerio de Economía y Competitividad, Spain

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Other Global dynamic balance in anterior direction Anterior reaching distance during unipodal stance (units: centimeters) Baseline - 6 weeks
Other Global dynamic balance in posteromedial direction Posteromedial reaching distance during unipodal stance (units: centimeters) Baseline - 6 weeks
Other Global dynamic balance in posterolateral direction Posterolateral reaching distance during unipodal stance (units: centimeters) Baseline - 6 weeks
Other Mean radial error of center of pressure in upright tandem stance Postural control in upright tandem stance condition evaluated through the mean radial error of center of pressure displacement (Units: millimeters) Baseline - 6 weeks
Other Trunk extensors isometric endurance Time to maintain a particular position against gravity until exhaustion using Biering-Sorensen test; (Units: seconds) Baseline - 6 weeks
Other Trunk flexors isometric endurance Time to maintain a particular position against gravity until exhaustion using using Plank test; (Units: seconds) Baseline - 6 weeks
Other Trunk lateral flexors isometric endurance Time to maintain a particular position against gravity until exhaustion using Side Bridge test; (Units: seconds) Baseline - 6 weeks
Other Neuromuscular function of lower extremity Triple hop test (Units: centimeters) Baseline - 6 weeks
Primary 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) Baseline - 6 weeks
Primary Trunk angular displacement Trunk angular displacement after sudden loading perturbations in different planes of motion (units: degrees) Baseline - 6 weeks
Primary Pelvis mean acceleration Pelvis mean acceleration in different isometric stabilization exercises measured with a smartphone accelerometer (Units: m/s2) Baseline - every 2 weeks up to 6 weeks
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