Respiratory Muscle Training for Healthy Adults

Overseen By Satvir Dhillon, MSc

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of British Columbia

Disqualifiers: Smoking, Cardiopulmonary disease, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 5 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new breathing device called BreathWayBetter to address breathing discomfort and muscle function. It focuses on isocapnic respiratory muscle endurance training, a specific breathing exercise, to determine its effects on exercise performance and breathlessness. Participants will be divided into two groups: one with low-intensity training and another with progressively higher intensity. This study is ideal for road cyclists or triathletes who regularly train and have normal lung function. As an unphased trial, it offers participants the opportunity to contribute to innovative research that could enhance athletic performance and respiratory health.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the BreathWayBetter device is safe for respiratory muscle training?

Research has shown that isocapnic respiratory muscle endurance training is generally easy for people to handle. Studies have found that it strengthens breathing muscles and improves exercise performance, even for those with chronic illnesses. Researchers consider this training safe, with no major safety issues reported.

For instance, one review found that this training increased breathing endurance without significant side effects. Another study noted that isocapnic training effectively builds breathing strength and coordination. Overall, these findings suggest that the training is safe and may help reduce shortness of breath during exercise. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Isocapnic Respiratory Muscle Endurance Training for healthy adults because it's a novel approach to enhancing respiratory fitness. Unlike traditional aerobic exercises that indirectly improve breathing capacity, this method directly targets the respiratory muscles, potentially leading to more efficient breathing and improved endurance. The trial compares two distinct approaches: a low frequency and intensity regimen and a progressive high frequency and intensity protocol, allowing researchers to explore the most effective way to bolster respiratory muscle strength and endurance. This could open new avenues for optimizing athletic performance and overall respiratory health.

What evidence suggests that this trial's respiratory muscle training methods could be effective for improving exercise performance and reducing breathlessness?

This trial will compare two different protocols of isocapnic respiratory muscle endurance training. Research has shown that this special type of breathing exercise strengthens breathing muscles and enhances physical performance. Studies have found that this training reduces breathlessness and improves the efficiency of the muscles used for breathing. It is particularly useful for increasing endurance during physical activities. For individuals with long-term health conditions, this training has improved the duration of sustained activity. Overall, evidence suggests it can ease breathing and make exercise more manageable. ^{1 2 6 7 8}

Who Is on the Research Team?

Jordan Guenette, PhD

Principal Investigator

University of British Columbia

Are You a Good Fit for This Trial?

This trial is for healthy adults interested in participating in a study to determine the effects of respiratory muscle endurance training. Specific eligibility criteria are not provided, so it's assumed that participants should be generally healthy without any major health issues.

Inclusion Criteria

Body mass index greater than 18 or less than 30 kg/m2

Normal pulmonary function: FEV1/FVC > 0.70 and FEV1 ≥ 80%

I am between 18 and 55 years old.

Exclusion Criteria

Required to read and understand English due to the nature of the consent form and study materials, including questionnaires and training instructions, which are only available in English.

Currently smoke, vape, or use cannabis, or have a history of frequent smoking, vaping or cannabis use

Contraindications to exercise testing defined as anything that would prevent exercise under proper and safe conditions (e.g. a problem with the heart or lungs, muscle or bone injury, a serious infection)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo 5 weeks of voluntary isocapnic hyperpnea (VIH) respiratory muscle training using the BreathWayBetter device

5 weeks

Weekly visits for training supervision

Follow-up

Participants are monitored for changes in dyspnoea ratings and VO2peak after the training period

2 weeks

2 visits (in-person) for post-intervention assessments

What Are the Treatments Tested in This Trial?

Interventions

• Isocapnic Respiratory Muscle Endurance Training

Trial Overview The study is testing how 5 weeks of voluntary isocapnic hyperpnea (VIH) using the BreathWayBetter device impacts breathlessness and muscle function compared to sham training. It aims to clarify VIH's role in improving respiratory care and exercise tolerance.

How Is the Trial Designed?

Group I: Progressive high frequency and intensity training Active Control 1 Intervention

Participant will perform a respiratory training following a progressive intensity and frequency protocol

Group II: Low frequency and intensity training Placebo Group 1 Intervention

Participant will perform a respiratory training following a low intensity and frequency protocol

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials

1,506

Recruited

2,528,000+

Mitacs

Industry Sponsor

Trials

46

Recruited

5,200+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07103291

Effects of Isocapnic Respiratory Muscle Endurance ... Respiratory muscle training (RMT) strengthens breathing muscles and may improve exercise performance and reduce breathlessness. However, different training ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9953077/

Effectiveness of Respiratory Muscles Training by Voluntary ... Respiratory muscle training (RMT) improves physical performance through increased efficiency of the muscles implicated in respiration, an aspect that preserves ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07103291?aggFilters=status%3A%2Csex%3Am%2Cages%3Aadult%2Chealthy%3Ay&ageRange=34.0y_34.0y

Effects of Isocapnic Respiratory Muscle Endurance ... An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a ...

4. physoc.onlinelibrary.wiley.com physoc.onlinelibrary.wiley.com/doi/full/10.1113/EP092300

Respiratory muscle endurance training among patients with ... This systematic review shows that respiratory muscle endurance training increases respiratory endurance among patients with chronic diseases.

5. journals.lww.com journals.lww.com/nsca-scj/fulltext/2024/12000/practical_application_of_respiratory_muscle.5.aspx

Practical Application of Respiratory Muscle Training in... RMT is associated with improved endurance performance and pulmonary function, and it reduced respiratory fatigue, perceived exertion, or breathlessness.

6. isocapnic.com isocapnic.com/blog/f/breaking-new-ground-cyril-riccis-study-validates-the-power-of-isocapnic-training

Cyril Ricci's Study Validates the Power of Isocapnic Training The Isocapnic BWB was designed with this exact purpose in mind—offering a safe, effective way to build respiratory strength, coordination, and ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11188215/

Influence of voluntary isocapnic hyperpnoea on recovery after ... Respiratory muscle training plays a significant role in reducing blood lactate concentration (bLa) and attenuating negative physiological stress ...

8. ahajournals.org ahajournals.org/doi/10.1161/01.CIR.91.2.320?doi=10.1161/01.CIR.91.2.320

Benefit of Selective Respiratory Muscle Training on ... Eight patients completed the training program. Respiratory muscle endurance was improved with training, as evidenced by increases in maximal sustainable ...