AzTrials
AzTrials

Physical ExertionCRSNCT03155633

Run, Recovery, Repeat, Always Healthy ("Corre, Recupera, Repite, Siempre Saludable")

A study testing Athletics track and Elliptical machine in people with Physical Exertion, run by Universitat Jaume I.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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… Read more about this study

Who is it for?
Ages 30 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Physical Exertion
What is being tested?
Athletics track and Elliptical machine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
98 participants
Where
No sites listed yet
Study dates
1 Jun 2016to 30 Nov 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • Having heart disease
  • Having kidney disease
  • Taking a medication on an ongoing basis

About this study

Official title: "Corre, Recupera, Repite, Siempre Saludable".

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 .

Read the 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

Being tested
Athletics track, Elliptical machine
Keywords
Marathon, runners, biomarkers, recovery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Athletics trackOther

    Running at 95-105% aerobic Threshold on athletics track 48h, 96h, 144h after the race. Control heart devices

  • Elliptical machineOther

    Running at 95-105% aerobic Threshold on elliptical machine 48h, 96h, 144h after the race. Control heart devices

Study groups in NCT03155633
Study groupRoleWhat they receive
Rest GroupNo interventionRest during the 9 days after the race
Running GroupExperimentalRunning at 95-105% aerobic Threshold on athletics track 48h, 96h, 144h after the race. Control heart devices
Receives: Other: Athletics track
Elliptical GroupExperimentalRunning at 95-105% aerobic Threshold on elliptical machine 48h, 96h, 144h after the race. Control heart devices
Receives: Other: Elliptical machine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in the Blood Physiological parameters

    Blood test

    Measured: baseline, 0, 24, 48, 96, 144 and 192 hours post-race

  2. 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

    Measured: 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

  3. Change in the Urin Physiological parameters

    Urin test

    Measured: baseline, 0, 48, 96, 144 and 192 hours post-race

Secondary outcomes (6)

  1. Self-reported questionnaire

    Personal questionnaire asking for social and training habits

    Measured: One month before the race day

  2. Strength level

    Squat Jump (cm). Two jumps per person

    Measured: pre-marathon race and 0, 48, 96, 144 hours post-marathon race

  3. Analysis of the change of body mass index

    BMI

    Measured: 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

  4. Physical Condition

    Maximal oxygen consumption

    Measured: One month before the marathon race day

  5. Body composition

    Bioimpedance analysis

    Measured: One month before the marathon race day

  6. Heart rate

    Recording the number of contractions of the heart per minute (bpm) by using a heart rate monitor during all the marathon race

    Measured: Through marathon completion, an average of 4 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 May 2017
  2. Study start1 Jun 2016
  3. Primary completion20 Oct 2016
  4. Study completion30 Nov 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
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
Masking
None (open label)
Enrolment
98 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03155633
Sponsor's protocol ID
UJI_CRS001
Acronym
CRS
Status last verified
May 2017
First submitted
26 Apr 2017
Last updated
16 May 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The data are administered by the Investigator Principal, other researchers must request the data they need by written request

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.

    PubMed 28052642

  • 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.

    PubMed 28382580

  • 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.

    PubMed 27911915

  • 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.

    PubMed 27609306

  • 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.

    PubMed 26073606

  • 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.

    PubMed 25665742

  • 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.

    PubMed 21642857

  • 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.

    PubMed 21484048

  • 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.

    PubMed 32796418

Questions about this trial

What is this clinical trial studying?

A study testing Athletics track and Elliptical machine in people with Physical Exertion, run by Universitat Jaume I.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 May 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the Blood Physiological parameters (time frame: baseline, 0, 24, 48, 96, 144 and 192 hours post-race). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03155633, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in