- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03155633
Run, Recovery, Repeat, Always Healthy ("Corre, Recupera, Repite, Siempre Saludable") (CRS)
"Corre, Recupera, Repite, Siempre Saludable".
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Rest Group
Rest during the 9 days after the race
|
|
Experimental: Running Group
Running at 95-105% aerobic Threshold on athletics track 48h, 96h, 144h after the race.
Control heart devices
|
Running at 95-105% aerobic Threshold on athletics track 48h, 96h, 144h after the race.
Control heart devices
|
Experimental: Elliptical Group
Running at 95-105% aerobic Threshold on elliptical machine 48h, 96h, 144h after the race.
Control heart devices
|
Running at 95-105% aerobic Threshold on elliptical machine 48h, 96h, 144h after the race.
Control heart devices
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the Blood Physiological parameters
Time Frame: baseline, 0, 24, 48, 96, 144 and 192 hours post-race
|
Blood test
|
baseline, 0, 24, 48, 96, 144 and 192 hours post-race
|
Analysis of tne changes in the Physical activity data
Time Frame: 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
|
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
|
Change in the Urin Physiological parameters
Time Frame: baseline, 0, 48, 96, 144 and 192 hours post-race
|
Urin test
|
baseline, 0, 48, 96, 144 and 192 hours post-race
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-reported questionnaire
Time Frame: One month before the race day
|
Personal questionnaire asking for social and training habits
|
One month before the race day
|
Strength level
Time Frame: pre-marathon race and 0, 48, 96, 144 hours post-marathon race
|
Squat Jump (cm).
Two jumps per person
|
pre-marathon race and 0, 48, 96, 144 hours post-marathon race
|
Analysis of the change of body mass index
Time Frame: 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
|
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
|
Physical Condition
Time Frame: One month before the marathon race day
|
Maximal oxygen consumption
|
One month before the marathon race day
|
Body composition
Time Frame: One month before the marathon race day
|
Bioimpedance analysis
|
One month before the marathon race day
|
Heart rate
Time Frame: Through marathon completion, an average of 4 hours
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Carlos Hernando, Universitat Jaume I
Publications and helpful links
General Publications
- Knechtle B, Nikolaidis PT, Zingg MA, Rosemann T, Rust 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. doi: 10.4077/CJP.2017.BAE400.
- Roca E, Nescolarde L, Lupon 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;10(2):206-208. doi: 10.1007/s12265-017-9744-2. Epub 2017 Apr 5.
- Santos VC, Sierra AP, Oliveira R, Cacula 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, Gorjao 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.
- Niemela M, Kangastupa P, Niemela 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. doi: 10.1080/00365513.2016.1225122. Epub 2016 Sep 9.
- 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.
- 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.
- 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.
- 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. doi: 10.1590/s1807-59322011000200018.
- Martinez-Navarro I, Montoya-Vieco A, Collado E, Hernando B, Panizo N, Hernando C. Muscle Cramping in the Marathon: Dehydration and Electrolyte Depletion vs. Muscle Damage. J Strength Cond Res. 2022 Jun 1;36(6):1629-1635. doi: 10.1519/JSC.0000000000003713. Epub 2020 Aug 12.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- UJI_CRS001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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