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Does the Dyspnea Challenge detect changes in exertional breathlessness?

Determining the Minimally Important Difference (MID) for Exertional Breathlessness measured using the Dyspnea Challenge in the COPD and Heart Failure populations.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12623000700639
Enrollment
3
Registered
2023-06-30
Start date
2023-03-01
Completion date
2027-06-30
Last updated
2026-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The purpose of the research is to evaluate the design of the ‘dyspnea challenge’, a two-minute treadmill protocol which has been developed to measure exertional dyspnea (ED) (“breathlessness”). ED is the feeling of discomfort in breathing during exercise/physical activity and it is the most common symptom of chronic heart and lung disease. It is important that a test is designed to precisely measure changes in ED over time as this will allow for the mechanisms behind ED to be better understood and for treatment pathways to be evaluated with greater accuracy. This study is looking at the impact that Pulmonary and Heart Failure Rehabilitation has on ED and whether the dyspnea challenge is able to detect any changes in ED. A minimally important difference for the dyspnea challenge will be established.

Interventions

The intervention for this study will be Pulmonary and Heart Failure exercise rehabilitation and what impact the exercise training has on exertional dyspnea in the COPD and Heart Failure populations. Participants will be required to attend two-three visits to be part of this study, one-two visits pre-rehabilitation (depending if all exercise testing can be completed in one visit, fatigue limited) and one visit post-rehabilitation. Participants will complete a two-minute treadmill exercise test

The intervention for this study will be Pulmonary and Heart Failure exercise rehabilitation and what impact the exercise training has on exertional dyspnea in the COPD and Heart Failure populations. Participants will be required to attend two-three visits to be part of this study, one-two visits pre-rehabilitation (depending if all exercise testing can be completed in one visit, fatigue limited) and one visit post-rehabilitation. Participants will complete a two-minute treadmill exercise test called the Dyspnea Challenge to assess exertional dyspnea pre and post an exercise training intervention. During the Dyspnea Challenge participants will walk at 80% of the pre-rehabilitation six minute walk test speed and at a grade that generates an exertional dyspnea score of at least 3-4 using the modified Borg Scale. The Pre-rehabilitation testing will be completed within 1 week prior to the commencement of exercise training. Following the exercise-based rehabilitation participants will repeat the Dyspnea Challenge at the same pre-rehabilitation treadmill speed and grade, with the primary outcome being the change in the end exercise dyspnea measured using the modified Borg Scale. Post-rehabilitation testing will be completed within 1 week of completion of the exercise program. Exercise training: Once to twice weekly dependent on the program participants undertake; group-based, 8-10 week exercise-based rehabilitation program run in an outpatient setting. Different rehabilitation sites run different length programs, same goes for number of sessions attended each week by participants. Participants don't select how many sessions they attend a week or for how long the program runs for this is standard for each site for all participants. Exercise training will be supervised by a physiotherapist and will be individually prescribed for each participant. Individualised exercise programs will be prescribed for intensity based off pre-rehabilitation exercise tests i.e. 6MWT. Participants will be exercising at a moderate to high intensity which is set off their pre-rehabilitation exercise tests and is monitored throughout the program using the Borg RPE. The exercise interventions will include aerobic, anaerobic, strength, core conditioning and stretching components based on the individual participants exercise goals and physical abilities. Examples of exercises frequently included: treadmill walking, cycling, light upper and lower limb resistance exercises. The supervised exercise training session should take approx. 45-60 min to complete. Participants are encouraged to complete a similar home exercise program 3-4 times a week additional to the supervised sessions. Participants will be monitored so that HR during training will be less than 90% of peak 6MWT HR, SaO2> 85% and RPE <13. If required, supplemental oxygen will be provided during exercise sessions to maintain SpO2> 85%. The number of exercise sessions attended by each participant over the 8-10 week intervention will be recorded.

Sponsors

Professor Norman Morris
Lead SponsorIndividual

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. A known diagnosis of COPD (GOLD I – IV) or Heart Failure (NYHA I – IV). 2. Clinically stable and/or on stable, optimized therapy for two weeks prior to enrolment for COPD patients and six weeks for heart failure patients.

Exclusion criteria

1. Significant co-morbidities that would exclude exertional exercise or any contraindications to exercise as outlined by the American College of Sports Medicine (ACSM's Guidelines for Exercise Testing and Prescription, Eighth Edition, 2010, Wolters Kluwer/LIppincott Williams and Wilkins. Philadelphia, USA) 2. Inability to walk on a treadmill

Outcome results

None listed

Source: ANZCTR · Data processed: Jun 11, 2026