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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05936398
Other study ID # TK02/2023
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2023
Est. completion date April 30, 2023

Study information

Verified date June 2023
Source Institute of Sport - National Research Institute, Poland
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date April 30, 2023
Est. primary completion date April 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
Poland Institute of Sport - National Research Institute Warsaw

Sponsors (1)

Lead Sponsor Collaborator
Institute of Sport - National Research Institute, Poland

Country where clinical trial is conducted

Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Primary 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.
Primary 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.
Primary 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.
Primary 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.
Primary 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.
Primary 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.
Primary 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.
Primary 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.
Primary 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.
Primary 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.
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