NCT02481063

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2015

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

May 27, 2015

Completed
5 days until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
24 days until next milestone

First Posted

Study publicly available on registry

June 25, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

August 21, 2015

Status Verified

June 1, 2015

Enrollment Period

Same day

First QC Date

May 27, 2015

Last Update Submit

August 20, 2015

Conditions

Keywords

EccentricRunningMuscleTendonUltrasoundThermography

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Temperature changes in Patellar and Achilles Tendon as assessed by thermography

    Change from Baseline in tendon structure after 3 days of running. Just immediately and 10 minutes after intervention

Study Arms (2)

Eccentric

ACTIVE COMPARATOR

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

Other: ControlOther: Eccentric Overload

Control

ACTIVE COMPARATOR

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

Other: Control

Interventions

ControlOTHER

3 Consecutive Days Running at 80% Maximus Heart Rate

ControlEccentric

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

Eccentric

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad San Jorge

Villanueva de Gállego, Zaragoza, 50830, Spain

Location

MeSH Terms

Conditions

Athletic Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • César Berzosa, Ph.D

    Universidad San Jorge

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2015

First Posted

June 25, 2015

Study Start

June 1, 2015

Primary Completion

June 1, 2015

Study Completion

August 1, 2015

Last Updated

August 21, 2015

Record last verified: 2015-06

Locations