Influence of Different Methods of Respiratory Muscle Training on Athletic Performance and Pulmonary Function in Short-track Speedskaters

June 29, 2023 updated by: Tomasz Kowalski, Institute of Sport - National Research Institute, Poland

This research aims to explore the impact of two distinct methods of respiratory muscle training, voluntary isocapnic hyperpnoea (VIH) and inspiratory pressure threshold loading (IPTL), on athletic performance and pulmonary function in short-track speedkaters. The study will employ a parallel group-randomized trial design and will span a period of six weeks, during which participants will undergo regular, partially supervised training sessions.

The primary objective of the research is to assess the changes in athletic performance resulting from respiratory muscle training using VIH and IPTL techniques. Athletic performance will be measured through a range of standardized performance tests relevant to the participants' specific sporting activities (Wingate Test, CPET, on-ice time-trial performance). Pulmonary function will be measured by spirometry examination.

The group will consist of healthy, highly-trained professional short-track speedskaters.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study aims to investigate the effects of two different respiratory muscle training methods, namely voluntary isocapnic hyperpnoea (VIH) and inspiratory pressure threshold loading (IPTL), on athletic performance and pulmonary function. The research will adopt a parallel group-randomized trial design, spanning a six-week period of regular, partially supervised training sessions.

The primary objective is to evaluate changes in athletic performance resulting from respiratory muscle training using VIH and IPTL techniques. Standardized performance tests relevant to the participants' specific sports will be utilized (Wingate Test, CPET, on-ice time-trial performance).

In addition, the impact of respiratory muscle training on pulmonary function will be assessed, focusing on parameters such as forced vital capacity (FVC), forced expiratory volume in one second (FEV1), peak expiratory flow (PEF). These measurements will provide insights into the potential enhancements of respiratory muscle strength and function through VIH and IPTL.

Participants will be randomly assigned to either the VIH or IPTL training group. Regular training sessions will be conducted under partial supervision to ensure proper technique and adherence. Close monitoring will be implemented to track progress and identify any potential adverse effects.

The findings of this research will hold implications for athletes and individuals seeking to optimize their athletic performance and respiratory muscle function. By comparing the effects of VIH and IPTL, the study aims to identify the most effective respiratory muscle training method.

Ultimately, this research will contribute to the existing knowledge on respiratory muscle training and its potential benefits for athletes and individuals engaged in physical activities. The results obtained will provide evidence-based guidance for the development of targeted training protocols that can enhance athletic performance and respiratory health.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Warsaw, Poland, 01-982
        • Institute of Sport - National Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • valid medical certificate to compete sports professionally,
  • lack of ongoing medication intake,
  • lack of any medical condition,
  • lack of previous experience with RMT,
  • performance caliber corresponding to at Elite/World Class (Participant Classification Framework, McKay 2022).

Exclusion Criteria:

  • any ongoing medication intake or medical condition.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Voluntary Isocapnic Hyperpnoea (VIH)
Group performing respiratory muscle training with Voluntary Isocapnic Hyperpnoea (VIH) method.
Behavioral: Respiratory Muscle Training - VIH
The VIH group will train every second day with gradual progression based on session length and breathing frequency. Participants will begin with 3 minutes of exercise with a frequency of 20 breaths·min-1 during the first session and add no more than 1 minute or 2 breaths·min-1 with each consecutive session.
Active Comparator: Inspiratory Pressure Threshold Loading (IPTL)
Group performing respiratory muscle training with Inspiratory Pressure Threshold Loading (IPTL) method.
Behavioral: Respiratory Muscle Training - ITPL
The IPTL group will train 5 days a week, twice a day, with at least 6 hours break between sessions. The session will consist of 30 dynamic inspiratory maneuvers with progressive overload based on gradually increased resistance. The VIH group will train every second day with gradual progression based on session length and breathing frequency. Participants will begin with 3 minutes of exercise with a frequency of 20 breaths·min-1 during the first session and add no more than 1 minute or 2 breaths·min-1 with each consecutive session.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in Maximum Power in Wingate Test
Time Frame: before and after the intervention (6-weeks)
Difference between maximum power achieved in Wingate Test in Week 1 and maximum power achieved in Wingate Test in Week 6 of the intervention. Unit: watts per kg
before and after the intervention (6-weeks)
Changes in Total Work in Wingate Test
Time Frame: before and after the intervention (6-weeks)
Difference between total work performed in Wingate Test in Week 1 and total work performed in Wingate Test in Week 6 of the intervention. Unit: kilojouls
before and after the intervention (6-weeks)
Changes in VO2max measured with cycloergometer cardiopulmonary exercise testing
Time Frame: before and after the intervention (6-weeks)
Difference between VO2 measured in Week 1 and VO2 measured in Week 6 of the intervention. Unit: mL/min/kg.
before and after the intervention (6-weeks)
Changes in forced volume vital capacity (FVC) measured with spirometry test
Time Frame: before and after the intervention (6-weeks)
Difference between FVC measured in Week 1 and FVC measured in Week 6 of the intervention. Unit: litres.
before and after the intervention (6-weeks)
Changes in on-ice performance measured with time trial effort
Time Frame: before and after the intervention (6-weeks)
Changes in time achieved during on-ice time trial performance in Week 1 and time achieved during on-ice time trial performance in Week 6 of the intervention. Unit: time in seconds
before and after the intervention (6-weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Institute of Sport - National Research Institute, Poland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 15, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 30, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 22, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 29, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 10, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 10, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 29, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TK01/2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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