NCT05936398

Brief Summary

Two groups of healthy, highly trained triathletes trained respiratory muscles with one of the two methods: voluntary isocapnic hyperpnoea (VIH) or inspiratory pressure threshold loading (IPTL). The main purpose of this study was to accurately and thoroughly assess the potential extra load that RMT puts on athletes and determine if there are significant differences in RMT-induced load between the investigated training methods. Informed written consent was obtained from the all study participants. All procedures were carried out in accordance with the Declaration of Helsinki.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 23, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 7, 2023

Completed
Last Updated

July 7, 2023

Status Verified

June 1, 2023

Enrollment Period

2 months

First QC Date

June 23, 2023

Last Update Submit

June 30, 2023

Conditions

Athletic Performance

Outcome Measures

Primary Outcomes (11)

  • Changes in measured blood indices to assess the potential extra load that RMT puts on athletes and determine if there are significant differences in RMT-induced load between the investigated training methods (pH)

    Differences in pre- and post- RMT session in pH.

    Week 1, 4 and 6 after monitored RMT sessions.

  • Changes in measured blood indices to assess the potential extra load that RMT puts on athletes and determine if there are significant differences in RMT-induced load between the investigated training methods (pO2).

    Differences in pre- and post- RMT session in pO2.

    Week 1, 4 and 6 after monitored RMT sessions.

  • Changes in measured blood indices to assess the potential extra load that RMT puts on athletes and determine if there are significant differences in RMT-induced load between the investigated training methods (pCO2).

    Differences in pre- and post- RMT session in pCO2.

    Week 1, 4 and 6 after monitored RMT sessions.

  • Changes in measured blood indices to assess the potential extra load that RMT puts on athletes and determine if there are significant differences in RMT-induced load between the investigated training methods (CHO3).

    Differences in pre- and post- RMT session in CHO3. CHO3.

    Week 1, 4 and 6 after monitored RMT sessions.

  • Changes in measured blood indices to assess the potential extra load that RMT puts on athletes and determine if there are significant differences in RMT-induced load between the investigated training methods (lactate).

    Differences in pre- and post- RMT session in blood lactate levels.

    Week 1, 4 and 6 after monitored RMT sessions.

  • Changes in measured blood indices to assess the potential extra load that RMT puts on athletes and determine if there are significant differences in RMT-induced load between the investigated training methods (testosterone).

    Differences in pre- and post- RMT session in testosterone.

    Week 1, 4 and 6 after monitored RMT sessions.

  • Changes in measured blood indices to assess the potential extra load that RMT puts on athletes and determine if there are significant differences in RMT-induced load between the investigated training methods (cortisol).

    Differences in pre- and post- RMT session in cortisol.

    Week 1, 4 and 6 after monitored RMT sessions.

  • Changes in cardiac indices to assess the potential extra load that RMT puts on athletes and determine if there are significant differences in RMT-induced load between the investigated training methods.

    Differences in HR indices between methods, increase of HR and decrease of HR after the cessation on the exercise.

    Week 1, 4 and 6 after monitored RMT sessions.

  • Collecting subjective measures to assess the potential extra load that RMT puts on athletes and determine if there are significant differences in RMT-induced load between the investigated training methods (RPE)

    Collecting perceived exertion numbers (Rate of Perceived Exertion - RPE)

    Week 1, 4 and 6 after monitored RMT sessions.

  • Collecting subjective measures to assess the potential extra load that RMT puts on athletes and determine if there are significant differences in RMT-induced load between the investigated training methods (MPQ).

    Collecting McGill Pain Questionnaire immediately post-session (MPQ scale).

    Week 1, 4 and 6 after monitored RMT sessions.

  • Collecting local blood oxygenation during RMT to assess the potential extra load that RMT puts on athletes and determine if there are significant differences in RMT-induced load between the investigated training methods.

    Measuring SMO2 before, during and after RMT sessions to assess induced changes.

    Week 1, 4 and 6 after monitored RMT sessions.

Study Arms (2)

Voluntary Isocapnic Hyperpnoea (VIH)

ACTIVE COMPARATOR

Group performing respiratory muscle training with Voluntary Isocapnic Hyperpnoea (VIH) method.

Behavioral: Respiratory Muscle Training - VIH

Inspiratory Pressure Threshold Loading (IPTL)

ACTIVE COMPARATOR

Group performing respiratory muscle training with Inspiratory Pressure Threshold Loading (IPTL) method.

Behavioral: Respiratory Muscle Training - ITPL

Interventions

Respiratory Muscle Training - VIHBEHAVIORAL

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.

Voluntary Isocapnic Hyperpnoea (VIH)
Respiratory Muscle Training - ITPLBEHAVIORAL

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.

Inspiratory Pressure Threshold Loading (IPTL)

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • valid medical certificate to compete sports professionally,
  • lack of ongoing medication intake,
  • lack of any medical condition,
  • lack of previous experience with RMT,
  • lack of previous experience with RMT,
  • performance caliber corresponding to at HighlyTrained/Elite (Participant Classification Framework, McKay 2022),
  • at least 6 years of triathlon training,
  • average training volume over 12 hours per week during last 6 weeks.

You may not qualify if:

  • any ongoing medication intake or medical condition.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Sport - National Research Institute

Warsaw, 01-982, Poland

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist

Study Record Dates

First Submitted

June 23, 2023

First Posted

July 7, 2023

Study Start

March 1, 2023

Primary Completion

April 30, 2023

Study Completion

April 30, 2023

Last Updated

July 7, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)