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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03155633
Other study ID # UJI_CRS001
Secondary ID
Status Completed
Phase N/A
First received April 26, 2017
Last updated May 15, 2017
Start date June 1, 2016
Est. completion date November 30, 2016

Study information

Verified date May 2017
Source Universitat Jaume I
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study has as main objective to know how the processes of recovery are realized after a race of marathon. For this, the participants of a marathon race are divided into three work groups during the 9 days post-marathon, one with rest in the recovery period, another with continuous race three sessions every 48h and another with three sessions of elliptical every 48h .


Description:

The marathon runners suffer a high fatigue, as has been studied by different investigations, the proposal of this study is to know how the recovery processes are produced in runners who have completed a 42km test.

To do this, baseline measurements of the runners have been made through stress tests and determinations of biomarkers in blood and urine. Subsequently blood and urine samples were taken the day before the marathon test and blood and urine samples were then taken again on arrival at 24h, 48h, 96h, 144h, and 196h.

At the same time, an intervention was carried out in the recovery phase, with the runners in three groups. The first one performed rests during the 9 days after the race, the second performed continuous race monitored every 48h from the end of the race, and the third group performed aerobic work on an elliptical machine under the same conditions as the group of Continuous race


Recruitment information / eligibility

Status Completed
Enrollment 98
Est. completion date November 30, 2016
Est. primary completion date October 20, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 30 Years to 45 Years
Eligibility Inclusion Criteria:

- Adults healthy with 30-45 years

- BMI between 16-24,99

- Time in marathon between 3h-4h in men

- Time in marathon between 3h:30min-4h:40min in women

Exclusion Criteria:

- Having heart disease

- Having kidney disease

- Taking a medication on an ongoing basis

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Athletics track
Running at 95-105% aerobic Threshold on athletics track 48h, 96h, 144h after the race. Control heart devices
Elliptical machine
Running at 95-105% aerobic Threshold on elliptical machine 48h, 96h, 144h after the race. Control heart devices

Locations

Country Name City State
n/a

Sponsors (4)

Lead Sponsor Collaborator
Universitat Jaume I Fundación Hospitales NISA, Fundación Trinidad Alfonso, SD. Correcaminos

References & Publications (8)

Kim YJ, Ahn JK, Shin KA, Kim CH, Lee YH, Park KM. Correlation of Cardiac Markers and Biomarkers With Blood Pressure of Middle-Aged Marathon Runners. J Clin Hypertens (Greenwich). 2015 Nov;17(11):868-73. doi: 10.1111/jch.12591. Epub 2015 Jun 13. — View Citation

Knechtle B, Knechtle P, Barandun U, Rosemann T, Lepers R. Predictor variables for half marathon race time in recreational female runners. Clinics (Sao Paulo). 2011;66(2):287-91. — View Citation

Knechtle B, Knechtle P, Rosemann T, Lepers R. Personal best marathon time and longest training run, not anthropometry, predict performance in recreational 24-hour ultrarunners. J Strength Cond Res. 2011 Aug;25(8):2212-8. doi: 10.1519/JSC.0b013e3181f6b0c7. — View Citation

Knechtle B, Nikolaidis PT, Zingg MA, Rosemann T, Rüst CA. Differences in age of peak marathon performance between mountain and city marathon running - The ‘Jungfrau Marathon’ in Switzerland. Chin J Physiol. 2017 Feb 28;60(1):11-22. — View Citation

Niemelä M, Kangastupa P, Niemelä O, Bloigu R, Juvonen T. Individual responses in biomarkers of health after marathon and half-marathon running: is age a factor in troponin changes? Scand J Clin Lab Invest. 2016 Nov;76(7):575-580. Epub 2016 Sep 9. — View Citation

Roca E, Nescolarde L, Lupón J, Barallat J, Januzzi JL, Liu P, Cruz Pastor M, Bayes-Genis A. The Dynamics of Cardiovascular Biomarkers in non-Elite Marathon Runners. J Cardiovasc Transl Res. 2017 Apr 5. doi: 10.1007/s12265-017-9744-2. [Epub ahead of print] — View Citation

Santos VC, Sierra AP, Oliveira R, Caçula KG, Momesso CM, Sato FT, Silva MB, Oliveira HH, Passos ME, de Souza DR, Gondim OS, Benetti M, Levada-Pires AC, Ghorayeb N, Kiss MA, Gorjão R, Pithon-Curi TC, Cury-Boaventura MF. Marathon Race Affects Neutrophil Surface Molecules: Role of Inflammatory Mediators. PLoS One. 2016 Dec 2;11(12):e0166687. doi: 10.1371/journal.pone.0166687. eCollection 2016. — View Citation

Tojima M, Noma K, Torii S. Changes in serum creatine kinase, leg muscle tightness, and delayed onset muscle soreness after a full marathon race. J Sports Med Phys Fitness. 2016 Jun;56(6):782-8. Epub 2015 Feb 10. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in the Blood Physiological parameters Blood test baseline, 0, 24, 48, 96, 144 and 192 hours post-race
Primary Analysis of tne changes in the Physical activity data Physical activity measured by wearing accelerometer devices. Physical activity defined as sedentary, light, moderate and vigorous. The aim to wear accelerometers devices is to monitor individuals during recovery time post-marathon race One month before the pre-race, accelerometers were worn during seven days. Accelerometers were also worn during nine days starting from the night before the marathon race
Primary Change in the Urin Physiological parameters Urin test baseline, 0, 48, 96, 144 and 192 hours post-race
Secondary Self-reported questionnaire Personal questionnaire asking for social and training habits One month before the race day
Secondary Strength level Squat Jump (cm). Two jumps per person pre-marathon race and 0, 48, 96, 144 hours post-marathon race
Secondary Analysis of the change of body mass index BMI one month before the marathon race day, 24 hours before the marathon race, 2 hours before the marathon race and 10 minutes after the marathon race
Secondary Physical Condition Maximal oxygen consumption One month before the marathon race day
Secondary Body composition Bioimpedance analysis One month before the marathon race day
Secondary Heart rate Recording the number of contractions of the heart per minute (bpm) by using a heart rate monitor during all the marathon race Through marathon completion, an average of 4 hours
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