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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02481063
Other study ID # TF_US20015
Secondary ID
Status Completed
Phase N/A
First received May 27, 2015
Last updated August 20, 2015
Start date June 2015
Est. completion date August 2015

Study information

Verified date June 2015
Source Universidad San Jorge
Contact n/a
Is FDA regulated No
Health authority Spain: Ethics Committee
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 19
Est. completion date August 2015
Est. primary completion date June 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years and older
Eligibility 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 donĀ“t complete all the procedure will be excluded.

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Screening


Related Conditions & MeSH terms


Intervention

Other:
Control
3 Consecutive Days Running at 80% Maximus Heart Rate
Eccentric Overload
Training with Eccentric Overload (Squat in Yoyo Technology) during 6 Weeks 3 Consecutive Days Running at 80% Maximus Heart Rate

Locations

Country Name City State
Spain Universidad San Jorge Villanueva de Gallego Zaragoza

Sponsors (2)

Lead Sponsor Collaborator
Universidad San Jorge University of Jaén

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Change from Baseline in tendon structure, an expected average of 3 days of running No
Secondary 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 Change from Baseline in tendon structure after 3 days of running. Just immediately and 10 minutes after intervention No
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