NCT03459430

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 19, 2018

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 8, 2018

Completed
2 days until next milestone

Study Start

First participant enrolled

March 10, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2018

Completed
Last Updated

February 8, 2019

Status Verified

February 1, 2019

Enrollment Period

10 months

First QC Date

February 19, 2018

Last Update Submit

February 7, 2019

Conditions

Keywords

trunk stabilityaccelerometersmartphonecore trainingisometric exercises

Outcome Measures

Primary Outcomes (3)

  • 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

  • Trunk angular displacement

    Trunk angular displacement after sudden loading perturbations in different planes of motion (units: degrees)

    Baseline - 6 weeks

  • 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

Other Outcomes (8)

  • Global dynamic balance in anterior direction

    Baseline - 6 weeks

  • Global dynamic balance in posteromedial direction

    Baseline - 6 weeks

  • Global dynamic balance in posterolateral direction

    Baseline - 6 weeks

  • +5 more other outcomes

Study Arms (3)

Low Intensity training group

EXPERIMENTAL

Low Intensity training group will complete a 6 week core stability training program with low intensity/oscillation exercises

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

Other: Core stability training

Control group

NO INTERVENTION

Control group will have 6 weeks with no intervention before post-test

Interventions

Effect of different core stability programs using diverse training intensities

High Intensity training groupLow Intensity training group

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \- Healthy recreative male athletes between 18 and 35 years old

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sport Research Center

Elche, Alicante, 03202, Spain

Location

Study Officials

  • Francisco J Vera-Garcia, Professor

    Universidad Miguel Hernandez de Elche, Spain

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Study Director

Study Record Dates

First Submitted

February 19, 2018

First Posted

March 8, 2018

Study Start

March 10, 2018

Primary Completion

December 21, 2018

Study Completion

December 21, 2018

Last Updated

February 8, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will share

All Individual Participant Data (IPD) that underlie results in a publication.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, 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

Locations