NCT06236490

Brief Summary

Blood Oxygen Level Test (BOLT) was never scientifically validated. Therefore, we investigated the association of BOLT scores with athletic performance in well-trained athletes. The study focuses on exercise tolerance in severe and extreme intensity domains, as they provoke significant homeostatic perturbations. We perform Wingate Anaerobic Test and Cardiopulmonary Exercise Test, which are part of the regular National Team athletes screening in our lab, to see if the results may be assocciated with BOLT results. The performance tests are used by the Speedskating National Team multiple times per year as training monitoring and performance assessments of the athletes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 1, 2024

Completed
Last Updated

February 2, 2024

Status Verified

January 1, 2024

Enrollment Period

4 months

First QC Date

January 24, 2024

Last Update Submit

January 31, 2024

Conditions

Keywords

boltblood oxygen level testchemosensitivitybaroreceptor sensitivity

Outcome Measures

Primary Outcomes (5)

  • Blood Oygen Level Score

    Voluntary breatholding untill the first signs of discomfort of respiratory muscle contraction, measured in seconds.

    June-September 2023

  • Wingate Test Result - total completed work

    Total work completed during Wingate 30 second test, measured in kilojouls

    June-September 2023

  • Maximal Oxygen Uptake - VO2max

    Maximal oxygen uptake, measured in ml/kg/min.

    June-September 2023

  • Time to cessation during cardiopulmonary testing

    Time in seconds from achieving oxygen uptate plateau to cessation of exercise.

    June-September 2023

  • Wingate Test Result - peak power

    Peak power during Wingate 30 second test, measured in watts.

    June-September 2023

Study Arms (1)

Study Particpants - Speedskating Athletes

All the study participants were members of the Polish National Development Team or Polish National Elite Team in either long-track or short-track speedskating. Inclusion criteria were as follows: a valid medical certificate for competitive speedskating, a minimum of six years of training, and no prior exposure to respiratory or respiratory muscle training. Exclusion criteria were as follows: any chronic medical conditions, recent acute medical conditions within the last 4 weeks, COVID-19 infection within the last 6 months, recent stay in an altitude over 1500 meters above sea level within the last 4 weeks, and the use of any ongoing medications.

Diagnostic Test: Blood Oxygen Level TestDiagnostic Test: Wingate Anaerobic TestDiagnostic Test: Cardiopulmonary Exercise Test

Interventions

The study participants rested for 15 minutes before measuring the BOLT score. During this time they were carefully instructed on how to perform the measurement. It was underlined that we do not measure how long one can hold their breath, but the time it takes for the body to react to lack of air and feel the desire to breathe. After a few normal breaths through the nose, after the exhalation, the participants held their breath until they felt the first definite desire to breathe or felt the first involuntary contractions of the respiratory muscles. The first was assessed by the participants, the latter was also visually assessed by the researchers. The nose was closed with the fingers to prevent any gas exchange. The researchers measured the time with a Finis 3x300M stopwatch (FINIS USA, Livermore, CA, USA). Time in seconds, to one decimal place, was noted as a BOLT score. The visualisation of BOLT is presented in Figure 2.

Study Particpants - Speedskating Athletes
Wingate Anaerobic TestDIAGNOSTIC_TEST

WAnT was conducted with Monark 874E Cycle Ergometer (Monark Exercise AB, Sweden). Before WAnT, the participants performed a 5-minute warm-up with resistance ranging from 0.8 to 1.2 W/kg. Next, the participants performed a maximal 6-second sprint, with the resistance adjusted to 7.5% of the individual body mass. After a rest interval of 2 to 5 minutes, the participants underwent a 30-second WAnT with resistance set at 7.5% of the individual body mass. They were instructed to attain the highest peak power output as quickly as possible and maintain the highest power output throughout the entire duration of the test. The participants received motivating and enthusiastic verbal support. The following indices were measured and included in the further analysis: peak power (Ppeak), total work (TW), WSSR. All the indices were calculated with the dedicated software (MCE 6.0, JBA Z. Staniak, Poland) linked to the cycle ergometer.

Study Particpants - Speedskating Athletes

CPET was performed with the Cortex Metamax B3 (Cortex Biophysik GmbH, Leipzig, Germany), breath-by-breath method, and Cyclus II Ergometer (RBM, Leipzig, Germany). Participants underwent an incremental ramp test, commencing at 55-70W and incrementally increasing the load by 0.17-0.28 W·sec-1, individually adjusted for body mass. The participants were instructed to continue the effort until total exhaustion. All the participants fulfilled the maximum effort criteria (Wiecha et al. 2023): 1) respiratory exchange ratio ≥ 1.10, (2) present VO2 plateau (growth \< 100 mL·min-1 in VO2 despite increased cycling power), (3) respiratory frequency ≥ 45 breaths·min-1, (4) declared subjective exertion intensity during CPET ≥ 18 according to the Borg Scale (Borg 1998), (5) blood lactate concentration ≥8 mmol·L-1, (6) peak heart rate ≥ 15 beats·min-1 below predicted maximal heart rate (HRmax) (Lach et al. 2021).

Study Particpants - Speedskating Athletes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Elite Speedskaters, Members of the National Team

You may qualify if:

  • a valid medical certificate for competitive speedskating,
  • a minimum of four years of competitive training,
  • no prior exposure to respiratory or respiratory muscle training.

You may not qualify if:

  • any chronic or acute medical condition within the last 4 weeks,
  • recent stay at an altitude over 1500 meters above sea level within the last 4 weeks,
  • the use of any ongoing medications, smoking, any ongoing allergy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Sport - National Research Institute

Warsaw, 01-982, Poland

Location

MeSH Terms

Interventions

Exercise Test

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemErgometryInvestigative Techniques

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 24, 2024

First Posted

February 1, 2024

Study Start

June 1, 2023

Primary Completion

September 30, 2023

Study Completion

September 30, 2023

Last Updated

February 2, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations