Investigate the cardiac and non-cardiac changes of first-time marathon training, running and recovery in healthy young men, according to COVID-19 status.
ID
Source
Brief title
Condition
- Cardiac disorders, signs and symptoms NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Our primary outcome is MRI characterization of cardiac morphological changes
and myocardial (mal)adaptation.
Secondary outcome
Secondary outcomes include other cardiac and non-cardiac parameters (training,
marathon and recovery related) as seen on echocardiography, CPET, ECG, and
changes in biomarkers (CRP, troponin I and T, pro BNP, CK) and fibrosis
biomarkers (CT-1 and Galectin-3).
Background summary
It is well documented that engaging in regular physical activity is associated
with numerous health benefits, such as a reduced risk of fatal and non-fatal
cardiovascular disease (CVD). However, it is unclear what the upper limits are
regarding the beneficial effects of physical exercise on the CV system and
general health. Marathon running is currently an activity with pronounced
popularity, with predominantly male participants aged 35-50. Correspondingly,
this is the age and gender group where a CVD first becomes clinically evident.
Adverse events such as sudden cardiac arrest (SCA) and sudden cardiac death
(SCD) have been reported among marathon runners, with a 10:1 incidence in men
versus women. Marathon runners may also develop deleterious CV effects, such as
coronary artery calcification, atrial fibrillation and myocardial fibrosis.
Elevations of biomarkers such as myocardial troponins and NT-pro-BNP have also
been demonstrated after acute bouts of endurance running, and changes in
cardiac structures and function have been shown to persist up to 1 week after a
marathon.
No studies have performed a comprehensive longitudinal cardiac evaluation,
including a complete battery of state-of-the-art diagnostic modalities and
continuous monitoring, in first-time marathon runners. Furthermore, running a
marathon after recovery from COVID-19 has never been investigated. Therefore,
we aim to investigate the effects of training for a marathon, performing a
marathon, and recovering from a marathon in first-time male runners, on cardiac
and non-cardiac indices.
Study objective
Investigate the cardiac and non-cardiac changes of first-time marathon
training, running and recovery in healthy young men, according to COVID-19
status.
Study design
A prospective, exploratory cohort study in apparently healthy young middle-aged
first-time male marathon runners. Subjects will be observed for 6 months,
including the different phases of 1) training; 2) the marathon event itself; 3)
recovery. Pre-marathon training will be at the participant's discretion and
unsupervised, but with a standard sports advice (progressive self-training for
4 months). Study evaluations comprise repeated CMR, echocardiography,
cardiopulmonary exercise testing (CPET), ECGs, blood tests and physical
activity reports.
Study burden and risks
The added risks of participation in this study are negligible. However, the
risks of marathon running carry a certain level of risk,. However, the marathon
running itself is not part of the study protocol, but an individual choice. MRI
has negligible health risks. The cardiac MRI protocol does include the
administration of gadolinium contrast bolus, but gadolinium contrast is well
tolerated with only very rare cases of gadolinium allergy (<0.1%). To exclude
the risk of contrast-induced nephrogenic systemic fibrosis, individuals with a
glomerular filtration rate < 30 ml/min will not be included. The echocardiogram
is a safe, non-invasive procedure using the high-frequency sound waves
(ultrasound). CPET, which involves measuring respiratory gases, is considered a
safe procedure, especially in healthy adults. The 12-lead ECG has no risks, and
subjects may only develop a skin rash from the adhesive ECG pads. The blood
collection has a small risk (<5%), causing a local hemorrhage, which is
unpleasant but harmless. Patients will be offered a guided training by a
licensed coach and a better understanding of the effects of first-time marathon
participation from participation in our study.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
(1) Men aged between 35-50
(2) No known (uncontrolled) medical illness
(3) Has no history of surgery for the past 2 years
(4) Does not suffer from musculoskeletal injury
(5) Has not run or trained for a marathon before
(6) Has not run further than 21.1 km in one single race or training in the last
year
(7) Has never trained or competed on a semi-professional or professional level
in endurance sports
Subgroup: We aim to include 12 participants (half of the study sample) with a
documented covid 19 history (PCR positive) without hospitalization in the past
6 months.
Exclusion criteria
Classified as high risk (symptomatic, or known cardiovascular, pulmonary, renal
or metabolic disease) according to ACSM guideline
Contraindications for MRI scanning (claustrophobia or other contra-indication
for MRI)
Glomerular filtration rate < 30 ml/min
Illiterate or unable to provide written informed consent
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
CCMO | NL70800.029.19 |
OMON | NL-OMON20364 |