NCT07103291

Brief Summary

Respiratory muscle training (RMT) strengthens breathing muscles and may improve exercise performance and reduce breathlessness. However, different training methods and devices create controversy in the field. Two main types of RMT exist: inspiratory muscle training (IMT) and respiratory endurance training, like voluntary isocapnic hyperpnea (VIH). While IMT is well-studied, the impact of VIH on breathlessness remains unclear. This study will use the Canadian-developed BreathWayBetter device to examine how 5 weeks of VIH affects breathing discomfort and muscle function. Findings may help personalize RMT for athletes and clinical patients, improving respiratory care and exercise tolerance.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
2mo left

Started Aug 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress81%
Aug 2025Aug 2026

First Submitted

Initial submission to the registry

July 10, 2025

Completed
25 days until next milestone

Study Start

First participant enrolled

August 4, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 5, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

May 15, 2026

Status Verified

May 1, 2026

Enrollment Period

12 months

First QC Date

July 10, 2025

Last Update Submit

May 13, 2026

Conditions

Keywords

Exercise physiologyRespiratory muscle trainingCyclingCompetitive cyclists

Outcome Measures

Primary Outcomes (2)

  • Change from baseline in dyspnoea ratings on the 0-10 Borg scale after respiratory endurance training

    Dyspnoea ratings on the 0-10 Borg scale will be recorded during and after incremental cardiopulmonary exercise testing on a stationary cycle ergometer. Dyspnoea ratings will then be compared between the pre- and post-intervention visits.

    Up to 7 weeks

  • Difference in maximal oxygen consumption (VO2peak) following high intensity training program compared to sham comparator program.

    Changes in peak oxygen consumption (VO2peak) will be measured during an incremental cardiopulmonary exercise test on a stationary cycle ergometer and compared between intervention conditions.

    Up to 7 weeks

Secondary Outcomes (1)

  • Correlation between changes from baseline in maximal oxygen consumption (VO2peak) and changes from baseline in dyspnoea ratings on the 0-10 Borg scale following respiratory endurance training.

    Up to 7 weeks

Study Arms (2)

Low frequency and intensity training

SHAM COMPARATOR

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

Other: Sham respiratory muscle endurance training

Progressive high frequency and intensity training

ACTIVE COMPARATOR

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

Other: Respiratory muscle endurance training

Interventions

Respiratory muscle endurance training program over 5 weeks.

Progressive high frequency and intensity training

Respiratory muscle endurance training program over 5 weeks following a sham training procedure that is meant to elicit no physiologic changes.

Low frequency and intensity training

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years of age (inclusive)
  • Male or Female (biological sex)
  • Body mass index greater than 18 or less than 30 kg/m2
  • Normal pulmonary function: FEV1/FVC \> 0.70 and FEV1 ≥ 80%
  • Able to read and understand English
  • Regularly trains and/or competes at a regional, national, or international level as a road cyclist or triathlete
  • Access to a device with the capability to download the Isocapnic app (Apple IOS or Google Play/Android) or the ability to use the Web Based application.

You may not qualify if:

  • Currently smoke, vape, or use cannabis, or have a history of frequent smoking, vaping or cannabis use
  • History of, or current symptoms of cardiopulmonary (i.e., lung and/or heart) disease (excluding controlled asthma)
  • Heart problem; a serious infection within the body; a neuromuscular (nerve to muscle) or musculoskeletal (muscle, ligament and/or bone) disorder; or other health problem that will be made worse with exercise testing
  • 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)
  • Currently pregnant
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

RECRUITING

Study Officials

  • Jordan Guenette, PhD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Olivia Ferguson, MSc

CONTACT

Satvir Dhillon, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 10, 2025

First Posted

August 5, 2025

Study Start

August 4, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

May 15, 2026

Record last verified: 2026-05

Locations