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Adaptation in Lower Extremity After 3 Running Days, With a Group Trained by Eccentric Overload

Primary Purpose

Sports Injuries

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Control
Eccentric Overload
Sponsored by
Universidad San Jorge
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Sports Injuries focused on measuring Eccentric, Running, Muscle, Tendon, Ultrasound, Thermography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy subjects that performs any sport usually
  • Subjects that never have made eccentric training will be included.
  • Subjects must be willing to perform the procedure
  • Sign informed consent

Exclusion Criteria:

  • Subjects enrolled with lower limb pathology in last 6 months
  • Subjects that don´t complete all the procedure will be excluded.

Sites / Locations

  • Universidad San Jorge

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Eccentric

Control

Arm Description

6 Weeks Training with eccentric Overload (Squat with Yoyo Technology) 3 Consecutive Days Running 1 hour at 80% of Maximus Heart Rate

3 Consecutive Days Running 1 hour at 80% of Maximus Heart Rate

Outcomes

Primary Outcome Measures

Composite Measure with Ultrasound in Tendons and Muscles
Ultrasound in Patellar and Achilles Tendon, to measure area, thickness and new blood vessels with Doppler. Ultrasound in Vastus Lateralis and Gastrocnemius Medialis to measure pennation angle

Secondary Outcome Measures

Temperature changes in Patellar and Achilles Tendon as assessed by thermography
Thermography in Patellar and Achilles Tendon in order to measure changes in temperature os these areas of interest

Full Information

First Posted
May 27, 2015
Last Updated
August 20, 2015
Sponsor
Universidad San Jorge
Collaborators
University of Jaén
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1. Study Identification

Unique Protocol Identification Number
NCT02481063
Brief Title
Adaptation in Lower Extremity After 3 Running Days, With a Group Trained by Eccentric Overload
Official Title
Differences in Muscle (Vastus Laterals and Gastrocnemius Medialis) and Tendon Adaptation (Patellar and Achilles) in Lower Extremity After 3 Running Days With a Group Trained by Eccentric Overload, Measured by Ultrasound and Thermography
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidad San Jorge
Collaborators
University of Jaén

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study evaluates the changes in muscles and tendons in the lower limb after an intervention of fatigue during 3 consecutive days between trained or not healthy subjects. One of the 2 groups received training by eccentric overload previously.
Detailed Description
Changes in muscle and tendon tissues, due to exercise, could determine in the future the possibility of an injury. Understand the changes in the mechanical tissues is a key tool for prevention. The evaluation of the thickness and area in tendons, the existence of new vessels within the tendon, muscle pennation angle or thermography are tools that have been widely used to detect these changes. Running is one of the activities that can cause more muscle-tendon injuries, specially overuse injuries. However, the eccentric exercise suggest to make some adaptations in different tissues that may be beneficial to prevent damage after exercise.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sports Injuries
Keywords
Eccentric, Running, Muscle, Tendon, Ultrasound, Thermography

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Eccentric
Arm Type
Active Comparator
Arm Description
6 Weeks Training with eccentric Overload (Squat with Yoyo Technology) 3 Consecutive Days Running 1 hour at 80% of Maximus Heart Rate
Arm Title
Control
Arm Type
Active Comparator
Arm Description
3 Consecutive Days Running 1 hour at 80% of Maximus Heart Rate
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
3 Consecutive Days Running at 80% Maximus Heart Rate
Intervention Type
Other
Intervention Name(s)
Eccentric Overload
Intervention Description
Training with Eccentric Overload (Squat in Yoyo Technology) during 6 Weeks 3 Consecutive Days Running at 80% Maximus Heart Rate
Primary Outcome Measure Information:
Title
Composite Measure with Ultrasound in Tendons and Muscles
Description
Ultrasound in Patellar and Achilles Tendon, to measure area, thickness and new blood vessels with Doppler. Ultrasound in Vastus Lateralis and Gastrocnemius Medialis to measure pennation angle
Time Frame
Change from Baseline in tendon structure, an expected average of 3 days of running
Secondary Outcome Measure Information:
Title
Temperature changes in Patellar and Achilles Tendon as assessed by thermography
Description
Thermography in Patellar and Achilles Tendon in order to measure changes in temperature os these areas of interest
Time Frame
Change from Baseline in tendon structure after 3 days of running. Just immediately and 10 minutes after intervention

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy subjects that performs any sport usually Subjects that never have made eccentric training will be included. Subjects must be willing to perform the procedure Sign informed consent Exclusion Criteria: Subjects enrolled with lower limb pathology in last 6 months Subjects that don´t complete all the procedure will be excluded.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
César Berzosa, Ph.D
Organizational Affiliation
Universidad San Jorge
Official's Role
Study Director
Facility Information:
Facility Name
Universidad San Jorge
City
Villanueva de Gallego
State/Province
Zaragoza
ZIP/Postal Code
50830
Country
Spain

12. IPD Sharing Statement

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Adaptation in Lower Extremity After 3 Running Days, With a Group Trained by Eccentric Overload

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