NCT03942562

Brief Summary

Basal measurements are taken in relation to the study variables. Immediately subjects perform eccentric exercise on right hamstrings to develop delayed onset muscle soreness (DOMS). Measurements of the study variables are taken in the same conditions 48, 96 and 168 hours after the exercise to study the evolution of the variables while recovering from DOMS.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2018

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 15, 2018

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 6, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 8, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2019

Completed
Last Updated

November 10, 2020

Status Verified

November 1, 2020

Enrollment Period

11 months

First QC Date

May 6, 2019

Last Update Submit

November 9, 2020

Conditions

Keywords

DOMSHealthy subjectsPressure pain thresholdsActive Knee Extension testMaximal strengthElectromyographyPlantar pressure measurementGait analysis

Outcome Measures

Primary Outcomes (1)

  • Changes in spatio temporal parameters of gait

    Changes in spatio temporal parameters of gait over a treadmill will be measurement using an optical measurement system consisting of a transmitting and receiving bar (OptoGait System).

    Baseline, 48 hours, 96 hours, 1 week

Secondary Outcomes (7)

  • Changes in Pressure Pain Thresholds

    Baseline, 48 hours, 96 hours, 1 week

  • Changes in active knee extension test

    Baseline, 48 hours, 96 hours, 1 week

  • Changes in knee-flexors maximal isometric muscle strength

    Baseline, 48 hours, 96 hours, 1 week

  • Electromyography (EMG) measurement during the tests

    Baseline, 48 hours, 96 hours, 1 week

  • Changes in thermography on hamstrings areas

    Baseline, 48 hours, 96 hours, 1 week

  • +2 more secondary outcomes

Eligibility Criteria

Age18 Years - 45 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Non sedentary healthy men

You may qualify if:

  • not sedentary subject (IPAQ scale \> 600 MET)
  • healthy subjects, without pain nor injury at the moment

You may not qualify if:

  • subjects with acute or chronic pain on every spot of pelvis or lower limbs at the momento or for the last 3 months;
  • subjects with history of severe injury in the hamstrings muscles;
  • presence of serious illness;
  • presence of pathologies in relation to chronic pain (as fibromyalgia, migraine disorders, non specific and chronic lumbar pain);
  • not commitment for continuity in the study program;

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

Myalgia

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesMusculoskeletal PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Víctor Doménech, MSc

    Universidad San Jorge

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
7 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2019

First Posted

May 8, 2019

Study Start

October 15, 2018

Primary Completion

August 31, 2019

Study Completion

August 31, 2019

Last Updated

November 10, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

We don't plan to share data collected

Locations