Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000700639
Ethics application status
Approved
Date submitted
13/04/2023
Date registered
30/06/2023
Date last updated
30/06/2023
Date data sharing statement initially provided
30/06/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does the Dyspnea Challenge detect changes in exertional breathlessness?
Scientific title
Determining the Minimally Important Difference (MID) for Exertional Breathlessness measured using the Dyspnea Challenge in the COPD and Heart Failure populations.
Secondary ID [1] 308935 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Exertional Dyspnea
 328941 0
Chronic Obstructive Pulmonary Disease 329780 0
Heart Failure 329781 0
Condition category
Condition code
Respiratory 325929 325929 0 0
Chronic obstructive pulmonary disease
Cardiovascular 325930 325930 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 325426 0
Rehabilitation
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 333845 0
Exertional Dyspnea measured using the Dyspnoea Challenge (a two minute graded, treadmill walking test)
Timepoint [1] 333845 0
Exertional dyspnea will be measured at the end of the Dyspnea Challenge within one week prior to and within one week of completing the 8-10 week Pulmonary or Heart Failure Rehabilitation program.
Secondary outcome [1] 418515 0
Quality of life using the St George Respiratory Questionnaire (SGRQ) for COPD participants
Timepoint [1] 418515 0
Questionnaires will be completed within one week prior to the commencement of the program and within one week of completing the 8-10 week Pulmonary or Heart Failure Rehabilitation program.
Secondary outcome [2] 418516 0
Dyspnea severity as assessed using the modified Medical Research Council (mMRC).
Timepoint [2] 418516 0
Questionnaires will be completed within one week prior to the commencement of the program and within one week of completing the 8-10 week Pulmonary or Heart Failure Rehabilitation program.
Secondary outcome [3] 418517 0
Disease severity as assessed using the New York Heart Association Functional class.
Timepoint [3] 418517 0
Questionnaires will be completed within one week prior to the commencement of the program and within one week of completing the 8-10 week Pulmonary or Heart Failure Rehabilitation program.
Secondary outcome [4] 418520 0
Exercise Capacity will be measured using the 6-min walk test (6MWT).
Timepoint [4] 418520 0
Within one week of completing the 8-10 week Pulmonary or Heart Failure Rehabilitation program.
Secondary outcome [5] 421060 0
Quality of life using the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) for Heart Failure participants.
Timepoint [5] 421060 0
Questionnaires will be completed within one week prior to the commencement of the program and within one week of completing the 8-10 week Pulmonary or Heart Failure Rehabilitation program.
Secondary outcome [6] 421061 0
Dyspnea severity as assessed using the Multidimensional Dyspnea Profile (MPD).
Timepoint [6] 421061 0
Questionnaires will be completed within one week prior to the commencement of the program and within one week of completing the 8-10 week Pulmonary or Heart Failure Rehabilitation program.
Secondary outcome [7] 421062 0
Dyspnea severity as assessed using the Dyspnoea-12.
Timepoint [7] 421062 0
Questionnaires will be completed within one week prior to the commencement of the program and within one week of completing the 8-10 week Pulmonary or Heart Failure Rehabilitation program.
Secondary outcome [8] 421063 0
Dyspnea severity as assessed using the Baseline/Transitional Dyspnea Index (BDI/TDI).
Timepoint [8] 421063 0
Questionnaires will be completed within one week prior to the commencement of the program and within one week of completing the 8-10 week Pulmonary or Heart Failure Rehabilitation program.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be recruited from multiple pulmonary and heart failure rehabilitation sites: 1. The Prince Charles Hospital, Brisbane.
2. Lung Smart and Heart Start, Bundaberg Health Promotions
3. Gold Coast University Hospital, Gold Coast.

Participants will be invited to participant in the study at their initial assessment session prior to commencing pulmonary or heart failure rehabilitation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
This study will aim to recruit 30 participants for both COPD and heart failure populations. Using GPower to calculate sample size based on a Power of 0.80, error probability of 0.05 and mBorg data from Aitken et al (2022) it was calculated that a minimum sample size n=24 is required, additional are planned to account for attrition.

A Minimally Important Difference (MID) of the dyspnea challenge will be calculated. Anchor and distribution based methods will be used to calculate the MID. The anchor for these calculations will be based on the MID for both the modified Borg scale of 1.0 (Ries, 2005) and the 6MWT which is 25m (Holland, et al 2010). The distribution base method for calculating the MID will use the sensitivity and specificity for change in 6MWD and Borg scale to discriminate between changes in individuals and a ROC curve will be obtained.

1. Aitken, C. R. et al. Optimising the Dyspnoea Challenge: exertional dyspnoea responses to changing treadmill gradients. Respir Physiol Neurobiol 302, 103915, doi:10.1016/j.resp.2022.103915 (2022).
2. Ries, A. L. Minimally clinically important difference for the UCSD shortness of breath questionnaire, borg scale, and visual analog scale. COPD 2, 105-110, doi:10.1081/copd-200050655 (2005).
3. Holland A. E., Hill C. J., Rasekaba T., Lee A., Naughton M. T., McDonald C. F. Updating the minimal important difference for six-minute walk distance in patients with chronic obstructive pulmonary disease. Arch Phys Med Rehabil 91 (2), 221-225, doi.org/10.1016/j.apmr.2009.10.017 (2010).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/03/2023
Date of last participant enrolment
Anticipated
1/04/2024
Actual
Date of last data collection
Anticipated
28/06/2024
Actual
Sample size
Target
30
Accrual to date
3
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 24058 0
The Prince Charles Hospital - Chermside
Recruitment hospital [2] 24059 0
Gold Coast University Hospital - Southport
Recruitment postcode(s) [1] 39560 0
4032 - Chermside
Recruitment postcode(s) [2] 39561 0
4215 - Southport
Recruitment postcode(s) [3] 39562 0
4670 - Bundaberg

Funding & Sponsors
Funding source category [1] 313144 0
University
Name [1] 313144 0
Griffith University
Country [1] 313144 0
Australia
Primary sponsor type
Individual
Name
Professor Norman Morris
Address
Griffith University
School of Allied Health Sciences
Gold Coast Campus
Parklands Drive
Southport QLD 4222
Country
Australia
Secondary sponsor category [1] 314848 0
Individual
Name [1] 314848 0
Ms Tanya Palmer
Address [1] 314848 0
Griffith University
School of Allied Health Sciences
Gold Coast Campus
Parklands Drive
Southport QLD 4222
Country [1] 314848 0
Australia
Other collaborator category [1] 282563 0
Hospital
Name [1] 282563 0
The Prince Charles Hospital
Address [1] 282563 0
Rode Road
Chermside QLD 4032
Country [1] 282563 0
Australia
Other collaborator category [2] 282564 0
Other Collaborative groups
Name [2] 282564 0
Bundaberg Health Promotions
Address [2] 282564 0
14 Branyan Street
Bundaberg QLD 4670
Country [2] 282564 0
Australia
Other collaborator category [3] 282565 0
Hospital
Name [3] 282565 0
Gold Coast University Hospital
Address [3] 282565 0
Gold Coast University Hospital
Parklands Drive
Southport QLD 4222
Country [3] 282565 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312387 0
Metro North Health Human Research Ethics Committee B
Ethics committee address [1] 312387 0
Ethics committee country [1] 312387 0
Australia
Date submitted for ethics approval [1] 312387 0
Approval date [1] 312387 0
12/01/2023
Ethics approval number [1] 312387 0
HREC/2019/QPCH/55714

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 124482 0
Prof Norman Morris
Address 124482 0
Griffith University
School of Allied Health Sciences
Gold Coast Campus
Parklands Drive
Southport QLD 4222
Country 124482 0
Australia
Phone 124482 0
+61 7 5552 8921
Fax 124482 0
Email 124482 0
[email protected]
Contact person for public queries
Name 124483 0
Norman Morris
Address 124483 0
Griffith University
School of Allied Health Sciences
Gold Coast Campus
Parklands Drive
Southport QLD 4222
Country 124483 0
Australia
Phone 124483 0
+61 756780162
Fax 124483 0
Email 124483 0
[email protected]
Contact person for scientific queries
Name 124484 0
Norman Morris
Address 124484 0
Griffith University
School of Allied Health Sciences
Gold Coast Campus
Parklands Drive
Southport QLD 4222
Country 124484 0
Australia
Phone 124484 0
+61 756780162
Fax 124484 0
Email 124484 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De identified participant data that underlie the results of the study
When will data be available (start and end dates)?
Following the publication of the study results with no end date.
Available to whom?
Researchers who provide a methodologically sound proposal for the use of the data, on a case-by-case basis at the discretion of Primary Sponsor.
Available for what types of analyses?
Any purpose, only for the achievement of the aims in the approved proposal
How or where can data be obtained?
Access will be subject to the approval of the Principal Investigator
Prof Norman Morris
School of Health Sciences and Social Work
The Menzies Health Institute
Griffith University
[email protected]


What supporting documents are/will be available?




Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.