NCT04078256

Brief Summary

Introduction: running is one of the most accessible and practiced sports in the world since the 21st century. Unfortunately, the incidence of injuries in the population that practices it is high regardless of experience, although the risk of injury increases in amateur runners. One of the main keys to reduce the incidence of running related injuries may be to improve the ability to reduce the load or impact. For this, there are different strategies such as a gradual increase in the load to run, and exercise within which is muscle strengthening and balance training or proprioception. Objective: to verify the effectiveness of a program of proprioceptive exercises based on the static and dynamic balance for the reduction of lower limb injuries in amateur runners during the competition season.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2019

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

August 30, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 6, 2019

Completed
25 days until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2020

Completed
Last Updated

May 26, 2020

Status Verified

May 1, 2020

Enrollment Period

4 months

First QC Date

August 30, 2019

Last Update Submit

May 22, 2020

Conditions

Keywords

proprioceptionrunningpreventioninjuries

Outcome Measures

Primary Outcomes (1)

  • Knee Joint Position Sense (JPS)

    JPSThe JPS is defined as the awareness of the actual position of the limb to quantify proprioception.The method for measuring JPS is to place the joint at a specific target angle and then, after the limb has been moved back to the starting angle, the subject is asked to actively or passively reproduce the target angle. The outcome of the measurement is the absolute error (AE), which is the difference between the true target angle and the reproduced angle

    Change from Baseline Joint Position Sense Pressure at 8 weeks

Secondary Outcomes (2)

  • The Y Balance Test (YBT)

    Change from Baseline dynamic balance at 8 weeks

  • The countermovement jump (CMJ)

    Change from Baseline jump height at 8 weeks

Study Arms (2)

Experimental group

EXPERIMENTAL

Group will carry out the proprioceptive exercise program during 8 weeks at the begining of the season

Other: Proprioceptive exercise program

Control group

PLACEBO COMPARATOR

Control group will continue with their usual training routine

Other: Usual training routine

Interventions

Group A will carry out two sessions of proprioceptive training per week, in a total of 8 weeks, during the pre-season period (September-October). Each session will last approximately 30 minutes and will include 6 exercises. The execution of the exercises will be supervised by a physiotherapist and a national trainer of athletics.

Experimental group

The subjects of the control group (group B) will be informed so that they do not include any change in their usual training routine.

Control group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Weekly training of at least 15 kilometers.
  • At least practice running 6 months for 1-3 times a week.

You may not qualify if:

  • To have some type of lower limb or lower back injury at present or in the last 6 months.
  • Having undergone surgery for any back or lower limb injury.
  • Pregnant.
  • Neural dysfunction / disability.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Grupo Fisioterapia y Dolor

Alcalá de Henares, Madrid, 28871, Spain

Location

MeSH Terms

Conditions

Athletic InjuriesWounds and Injuries

Study Officials

  • Tomas Gallego-Izquierdo, Dr.

    Alcala University

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

August 30, 2019

First Posted

September 6, 2019

Study Start

October 1, 2019

Primary Completion

January 25, 2020

Study Completion

March 10, 2020

Last Updated

May 26, 2020

Record last verified: 2020-05

Locations