- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05936398
Influence of Respiratory Muscle Training on Objective and Subjective Training Load Measures in Triathletes
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study was conducted as a randomized controlled trial with two parallel groups. Whereas participants and data collectors were aware of the allocated training method, the data analysts and laboratory technicians performing biochemistry assays were kept blinded to the allocation. The participants were assigned at random to either VIH or IPTL training group to perform RMT with progressive overload for 6 weeks.
Three training sessions (week 1, 4, 6) were monitor 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.
Blood samples used for acid-base balance (pH), partial pressure of oxygen (pO2), partial pressure for carbon dioxide (pCO2), partial pressure for bicarbonate ion (HCO3-), and blood lactate (bLa) were collected immediately after cessation of the exercise and MPQ was presented 1' after cessation of the exercise. Blood samples for cortisol (C) and testosterone (T) were collected 5' after cessation of the exercise. The second S-Index Test was performed between minute 5 and minute 7 after cessation of the exercise. RPE was assessed 10' after cessation of the exercise. The participants again answered MPQ after 24h and 48h after the monitored RMT sessions.
Informed written consent was obtained from the all study participants. All procedures were carried out in accordance with the Declaration of Helsinki.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Warsaw, Poland, 01-982
- Institute of Sport - National Research Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
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,
- 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.
Exclusion Criteria:
- any ongoing medication intake or medical condition.
Study Plan
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 |
Intervention / Treatment |
---|---|
Active Comparator: Voluntary Isocapnic Hyperpnoea (VIH)
Group performing respiratory muscle training with Voluntary Isocapnic Hyperpnoea (VIH) method.
|
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.
|
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
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
Time Frame: Week 1, 4 and 6 after monitored RMT sessions.
|
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).
Time Frame: Week 1, 4 and 6 after monitored RMT sessions.
|
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).
Time Frame: Week 1, 4 and 6 after monitored RMT sessions.
|
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).
Time Frame: Week 1, 4 and 6 after monitored RMT sessions.
|
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).
Time Frame: Week 1, 4 and 6 after monitored RMT sessions.
|
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).
Time Frame: Week 1, 4 and 6 after monitored RMT sessions.
|
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).
Time Frame: Week 1, 4 and 6 after monitored RMT sessions.
|
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.
Time Frame: Week 1, 4 and 6 after monitored RMT sessions.
|
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)
Time Frame: Week 1, 4 and 6 after monitored RMT sessions.
|
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).
Time Frame: Week 1, 4 and 6 after monitored RMT sessions.
|
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.
Time Frame: Week 1, 4 and 6 after monitored RMT sessions.
|
Measuring SMO2 before, during and after RMT sessions to assess induced changes.
|
Week 1, 4 and 6 after monitored RMT sessions.
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- TK02/2023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Athletic Performance
-
University of AarhusInnovation Fund DenmarkRecruitingAthletic PerformanceDenmark
-
University of the Incarnate WordCompletedAthletic PerformanceUnited States
-
University of LiegeCompleted
-
Antonio PaoliCompletedAthletic PerformanceItaly
-
Université de MontréalCompletedAthletic PerformanceCanada
-
Victory Nutrition International, Inc.RecruitingAthletic PerformanceUnited States
-
University of Erlangen-Nürnberg Medical SchoolGolfersworld München; Golfclub München-EichenriedCompletedAthletic PerformanceGermany
-
University Ramon LlullMònica Solana-Tramunt; Jose MoralesCompleted
-
Per Bendix JeppesenFuture Food InnovationCompletedAthletic PerformanceDenmark
-
Metropolitan University, SerbiaCompletedAthletic PerformanceSerbia
Clinical Trials on Respiratory Muscle Training - VIH
-
Institute of Sport - National Research Institute...Enrolling by invitationRespiratory Muscle TrainingPoland
-
Marmara UniversityCompleted
-
Abant Izzet Baysal UniversityNot yet recruitingChronic Obstructive Pulmonary Disease
-
Faculdade de Ciências Médicas da Santa Casa de...Completed
-
University of the State of Santa CatarinaCompletedHeart Diseases | Cardiovascular Diseases | Coronary Disease | Coronary Artery Occlusion
-
Universidade Federal de PernambucoCompletedMuscular Atrophy | Aging | Sensitivity Training GroupsBrazil
-
University of FloridaCompleted
-
Vanderbilt University Medical CenterNot yet recruitingDysphagia | Heart Transplant Recipients
-
University Hospital, GrenobleCompleted
-
Bezmialem Vakif UniversityCompletedParkinson DiseaseTurkey