Heart Arrest, Inflammatory Response, Oxidative Stress, Sport Injury
Conditions
Keywords
troponin-I, hs-CRP, Malondialdehyde, predictors
Brief summary
Prospective observational study to determine predictors that related to cardiac troponin I (cTnI) release, malondialdehyde (MDA) and high sensitivity C Reactive Protein (hs-CRP) after Tour de Borobudur (TdB) 2017
Detailed description
Eligible Criteria: 1. minimum sample size of 80 men, non-athlete, participants of TdB 2. Classified into two groups: 160kms cycling and 100kms cycling participation 3. 25-55 years old 4. voluntary participate in the research 5. eligible in pre participatory physical examination and ECG test by the doctor 6. have no history of the previous acute coronary syndrome (ACS) Measurements: Interview for determining predictors of sports participation history, medical history, family medical history and Rate of Perceived Exertion Measurement and examination to determine: anthropometry parameters, clinical conditions (Systolic BP, Diastolic BP, hemoglobin levels, T-cholesterol and HDL-C levels, the intensity in cycling activities (mileage, velocity, duration, and time for resting), hemodynamic responses (average and maximum heart rate, Karvonen Index), and Hydration status Other outcome measurements; pre and post-TdB 2017 measurements of cTnI, MDA, and hs-CRP
Interventions
OTHER140kms cycling
Main exposure is long distance cycling touring (TdB/NC) consists of three groups; 140kms, 100kms, and 240kms (investigator did not give any treatment/intervention, just observed the cycling touring event)
Sponsors
Ministry of Research, Technology and Higher Education, Republic of Indonesia
Universitas Diponegoro
Universitas Negeri Semarang
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
25 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* minimum sample size of 80 men, non athlete, participants of TdB * Classified into two groups: 160kms cycling and 100kms cycling participation * 25-55 years old * voluntary participate in the research * eligible in pre participatory physical examination and ECG test by doctor have no history of previous acute coronary syndrome (ACS)
Exclusion criteria
* stop cycling before finish line due to mechanical or bicycle related errors * (subjects who stop cycling due to any physical symptoms and health related problem included in analysis)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiac Troponin I (cTnI) | immediate after TdB 2017 cycling touring within less than 5 min | specific protein to determine cardiac injury |
| Malondialdehyde (MDA) | immediate after TdB 2017 cycling touring within less than 5 min | oxydative stress marker |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| High Sensitivity C Reactive Protein (Hs-CRP) | immediate after TdB 2017 cycling touring within less than 5 min | a biomarker that represents the inflammation process |
| Number of Participants With Pathological ECG Appearance | immediate after TdB 2017 cycling touring within less than 5 min | Number of Participants with Pathological ECG Appearance. Pathological ECG appearance was the results of the ECG test describing one of the pathological appearances in ECG i.e.: 1. The pathological rhythm which is may consist of Atrial Flutter, Atrial Fibrillation, Supraventricular Tachycardia, Ventricular Fibrillation, First Degree Heart Block, Second Degree Heart Block, Type 1 - Mobitz I, Second Degree Heart Block, Type 2 - Mobitz II, Third Degree Heart Block, or other pathological rhythm appearances 2. Pathological ST-segment i.e. ST elevation (early repolarization), or another form 3. Pathological U wave, and 4. other pathological appearances |
Countries
Indonesia
Participant flow
Recruitment details
Consecutive sampling was done by voluntary confirmation of participants in the 2017 North Coast tour (http://ina-northcoast-cyclingtour.com/index.html) and the 2017 Tour de Borobudur (https://event.sambabikers.com/). All participants were invited to participate in this observational study via an online advertisement on the website.
Pre-assignment details
Participants with a history of coronary artery diseases (CAD) were excluded from study participation. Subsequently, a total of 94 participants were included in this study
Participants by arm
| Arm | Count |
|---|---|
| Group 140kms Cycling willing to participate in 140kms cycling touring of TdB 2017
140kms cycling: main exposure is long distance cycling touring (TdB/NC) consists of three groups; 140kms, 100kms and 240kms | 30 |
| Group 100kms Cycling willing to participate in 100kms cycling touring of TdB 2017
140kms cycling: main exposure is long distance cycling touring (TdB/NC) consists of three groups; 140kms, 100kms and 240kms | 30 |
| Group 240kms Cycling willing to participate in 240kms cycling touring of NC 2017
140kms cycling: main exposure is long distance cycling touring (TdB/NC) consists of three groups; 140kms, 100kms and 240kms | 28 |
| Total | 88 |
Baseline characteristics
| Characteristic | Group 140kms Cycling | Group 100kms Cycling | Group 240kms Cycling | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 4 Participants | 0 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants | 26 Participants | 28 Participants | 84 Participants |
| Age, Continuous | 43.3 years STANDARD_DEVIATION 9.33 | 43.5 years STANDARD_DEVIATION 10.18 | 49.0 years STANDARD_DEVIATION 13.7 | 45.3 years STANDARD_DEVIATION 11.47 |
| cardiac troponin I (cTnI) | 5.2 ng/dL STANDARD_DEVIATION 9.98 | 6.6 ng/dL STANDARD_DEVIATION 10.56 | 3.5 ng/dL STANDARD_DEVIATION 8.93 | 5.2 ng/dL STANDARD_DEVIATION 9.83 |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Region of Enrollment Indonesia | 30 participants | 30 participants | 28 participants | 88 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 30 Participants | 30 Participants | 28 Participants | 88 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 | 0 / 28 |
| other Total, other adverse events | 0 / 30 | 0 / 30 | 0 / 28 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 | 0 / 28 |
Outcome results
Primary
Cardiac Troponin I (cTnI)
specific protein to determine cardiac injury
Time frame: immediate after TdB 2017 cycling touring within less than 5 min
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 140kms Cycling | Cardiac Troponin I (cTnI) | 6.6 ng/dL | Standard Deviation 46.6 |
| Group 100kms Cycling | Cardiac Troponin I (cTnI) | 10.1 ng/dL | Standard Deviation 10.44 |
| Group 240kms Cycling | Cardiac Troponin I (cTnI) | 25.0 ng/dL | Standard Deviation 61.39 |
Primary
Malondialdehyde (MDA)
oxydative stress marker
Time frame: immediate after TdB 2017 cycling touring within less than 5 min
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 140kms Cycling | Malondialdehyde (MDA) | 206.1 mcmol/mL | Standard Deviation 116.84 |
| Group 100kms Cycling | Malondialdehyde (MDA) | 196.4 mcmol/mL | Standard Deviation 68.59 |
| Group 240kms Cycling | Malondialdehyde (MDA) | 231.2 mcmol/mL | Standard Deviation 105.54 |
Secondary
High Sensitivity C Reactive Protein (Hs-CRP)
a biomarker that represents the inflammation process
Time frame: immediate after TdB 2017 cycling touring within less than 5 min
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 140kms Cycling | High Sensitivity C Reactive Protein (Hs-CRP) | 454 mg/dL | Standard Deviation 286.5 |
| Group 100kms Cycling | High Sensitivity C Reactive Protein (Hs-CRP) | 335 mg/dL | Standard Deviation 375.1 |
| Group 240kms Cycling | High Sensitivity C Reactive Protein (Hs-CRP) | 350 mg/dL | Standard Deviation 332.6 |
Secondary
Number of Participants With Pathological ECG Appearance
Number of Participants with Pathological ECG Appearance. Pathological ECG appearance was the results of the ECG test describing one of the pathological appearances in ECG i.e.: 1. The pathological rhythm which is may consist of Atrial Flutter, Atrial Fibrillation, Supraventricular Tachycardia, Ventricular Fibrillation, First Degree Heart Block, Second Degree Heart Block, Type 1 - Mobitz I, Second Degree Heart Block, Type 2 - Mobitz II, Third Degree Heart Block, or other pathological rhythm appearances 2. Pathological ST-segment i.e. ST elevation (early repolarization), or another form 3. Pathological U wave, and 4. other pathological appearances
Time frame: immediate after TdB 2017 cycling touring within less than 5 min
Population: Pathological ECG appearance
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 140kms Cycling | Number of Participants With Pathological ECG Appearance | 0 Participants |
| Group 100kms Cycling | Number of Participants With Pathological ECG Appearance | 0 Participants |
| Group 240kms Cycling | Number of Participants With Pathological ECG Appearance | 0 Participants |