Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000110684
Ethics application status
Approved
Date submitted
23/01/2023
Date registered
1/02/2023
Date last updated
1/02/2023
Date data sharing statement initially provided
1/02/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
The ‘heart rate’ for the lungs: can breathing-specific metrics be used to better tailor exercise training for people with chronic lung disease?
Scientific title
The ‘heart rate’ for the lungs: evaluating respiratory-specific parameters to optimise exercise prescription for people with chronic lung disease
Secondary ID [1] 308812 0
None
Universal Trial Number (UTN)
Trial acronym
HRFL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease 328771 0
Condition category
Condition code
Respiratory 325779 325779 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomised to one of three groups: 1) 25-minutes continuous exercise at a breathlessness intensity rating of between 3 to 5 on the 0-10 modified Borg scale (control); 2) 25-minutes continuous exercise at 90% of the critical inspiratory constraint threshold on tidal volume (CIC), where CIC is defined as the power output where a plateau in tidal volume (<0.15 L change) occurs despite increasing ventilation and the tidal volume is at least 73% of inspiratory capacity (intervention group 1); or 3) high intensity interval training (HIIT) at 110% CIC, with four 4-minute bouts of exercise interspersed with 3-minutes of rest at low intensity (intervention group 2). Each group will start and finish the exercise session with 5 minutes of low intensity cycling performed at 20% of peak power output.

For all groups, exercise training will be performed on an electronically braked cycle ergometer, supervised by a trained exercise specialist (exercise scientist or accredited exercise physiologist), and consist of 3 sessions per week, for 6 weeks. The duration of each session (assessments and exercise training) will typically last around 1 hour.

Throughout each exercise training session, participants in all groups will:
* Rate their breathlessness intensity and unpleasantness using Borg's 0-10 Category Ratio scale (Borg's CR10)
* Rate their level of leg discomfort using Borg's CR10
* Rate their affect using the Feeling Scale
* Have their heart rate, peripheral oxygen saturation (pulse oximeter), and blood pressure assessed
These measures will be taken before and after each session, and in the last 30-sec of the warmup and cool down, and every 5-minute interval during the training session for the control group and intervention 1 group, or at the end of every 4-min exercise bout for intervention 2 group (HIIT).

Participants attendance to each exercise session will be recorded with an attendance checklist, and any deviations to the exercise training protocol will be recorded in an exercise training log. This includes rest periods (frequency and duration) and/or changes to prescribed intensity. Adverse events will be recorded in the adverse events log.
Intervention code [1] 325263 0
Rehabilitation
Comparator / control treatment
The control group consists of 25-minutes continuous exercise at a breathlessness intensity rating of between 3 to 5 on the 0-10 modified Borg scale. This is consistent with how exercise is commonly prescribed in pulmonary rehabilitation programmes across Australia.

Participants will start and end the exercise session with 5 minutes of cycling at 20% peak power output.

For all groups, exercise training will be performed on an electronically braked cycle ergometer, supervised by a trained exercise specialist (exercise scientist or accredited exercise physiologist), and consist of 3 sessions per week, for 6 weeks. The duration of each session (assessments and exercise training) will typically last around 1 hour.

Throughout each exercise training session, participants will:
* Rate their breathlessness intensity and unpleasantness using Borg's 0-10 Category Ratio scale (Borg's CR10)
* Rate their level of leg discomfort using Borg's CR10
* Rate their affect using the Feeling Scale
* Have their heart rate, peripheral oxygen saturation (pulse oximeter), and blood pressure assessed
These measures will be taken before and after each session, and in the last 30-sec of the warmup and cool down, and every 5-minute interval during the training session.

Participants attendance to each exercise session will be recorded with an attendance checklist, and any deviations to the exercise training protocol will be recorded in an exercise training log. This includes rest periods (frequency and duration) and/or changes to prescribed intensity. Adverse events will be recorded in the adverse events log.
Control group
Active

Outcomes
Primary outcome [1] 333621 0
Exercise training intensity, which is defined as the power output measured automatically by the electronically braked cycle ergometer.
Timepoint [1] 333621 0
Final week of intervention (average) and change from first to last week
Primary outcome [2] 333622 0
Exercise training adherence, which includes the proportion of (i) total exercise sessions attended and (ii) completed as prescribed.

Participants attendance to each exercise session will be recorded with an attendance checklist, and any deviations to the exercise training protocol will be recorded in an exercise training log. This includes rest periods (frequency and duration) and/or changes to prescribed intensity. Adverse events will be recorded in the adverse events log.
Timepoint [2] 333622 0
The proportion of total sessions attended will be reported for the entire 6 week exercise training intervention.

The proportion of exercise sessions completed as prescribed will be reported for the entire 6 week exercise training intervention.
Secondary outcome [1] 417774 0
Average and range of breathlessness intensity and unpleasantness (Borg’s 0-10 category ratio scale)
Timepoint [1] 417774 0
Breathlessness intensity and unpleasantness is measured in the last 30-sec of every 5-minute interval during the training session for the control group and intervention 1 group, or at the end of every 4-min exercise bout for intervention 2 group (HIIT).

The average and range of these measures over the 6-week intervention will be assessed.
Secondary outcome [2] 417775 0
Average and range of affect (Feeling Scale)
Timepoint [2] 417775 0
Affect is measured in the last 30-sec of every 5-minute interval during the training session for the control group and intervention 1 group, or at the end of every 4-min exercise bout for intervention 2 group (HIIT).

The average and range of affect over the 6-week intervention will be assessed.
Secondary outcome [3] 417776 0
Peak rate of oxygen consumption (absolute and relative) assessed using incremental cycle exercise testing via a Hans Rudolph fitted face mask, with a flow turbine and breath-by-breath gas analysis.
Timepoint [3] 417776 0
within 14 days of completing the 6-week intervention
Secondary outcome [4] 417777 0
Peak power output (absolute and relative) assessed using incremental cycle exercise testing and defined as the highest power output sustained for at least 30-sec
Timepoint [4] 417777 0
within 14 days of completing the 6-week intervention
Secondary outcome [5] 417778 0
Daily life breathlessness assessed using the Multidimensional Dyspnoea Profile
Timepoint [5] 417778 0
within 14 days of completing the 6-week intervention
Secondary outcome [6] 417779 0
Vascular health (arterial stiffness and central haemodynamics, assessed using a SphygmoCor® XCEL)
Timepoint [6] 417779 0
within 14 days of completing the 6-week intervention
Secondary outcome [7] 417784 0
All adverse events will be assessed by clinical observation during the exercise session, and by participant self-report at subsequent exercise sessions/study assessment visits. That is, all participants will be asked if they experienced at side-effects or changes in their health status following the previous exercise session. All reported or identified adverse events will be recorded in the adverse events log with date of onset and end date, and detailed notes. The exercise specialist will grade the severity of the adverse event using the Common Terminology Criteria for Adverse Events (CTCAE4).

Examples of adverse events observed during the exercise session include: participant reported symptoms (e.g., pain, dizziness), abnormal heart rate or blood pressure responses to exercise. Examples of adverse events self-reported by participants include muscle soreness, pain, fatigue, etc.
Timepoint [7] 417784 0
Number of adverse events reported throughout the entire intervention duration.
Secondary outcome [8] 417863 0
Physical activity enjoyment assessed with the Physical Activity Enjoyment Scale (PACES)
Timepoint [8] 417863 0
Change in Physical Activity enjoyment from first to last session, and difference in enjoyment at the end of the final session between groups

Eligibility
Key inclusion criteria
• Are aged 18 years or older
• Self-report being previously diagnosed with COPD by a medical doctor
• Meet spirometric criteria for COPD according to Global initiative for Obstructive Lung Disease criteria (forced expiratory volume in 1-sec to forced vital capacity ratio of <0.70 and/or less than the lower limit of normal)
• Are willing and able to participate in a 6-week exercise training intervention involving cycle exercise
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Have contraindications to lung function testing in accordance with international clinical guidelines13 (American Thoracic Society/European Respiratory Society; heart attack; lung collapse; blood clot in the lung; aneurysm; eye, chest or stomach surgery; or any history of coughing up significant amounts of blood in the previous 3 months)
• Have significant extra-pulmonary disease that could impair exercise tolerance
• Have an important contraindication(s) to cardiopulmonary exercise testing (e.g., significant cardiovascular, musculoskeletal, neurological disease)
• Changed their respiratory medication dosage and/or frequency of administration in the preceding two weeks
• Had a disease exacerbation/hospitalisation in preceding six weeks

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is concealed by study design and by use of an off-site administrator. That is, all participants are screened for eligibility and enrolled in the study at visit 1. Eligible and consenting participants then perform all pre-intervention assessments at visit 1. Following visit 1, the participant's unique ID code is sent to an external administrator who assigns the intervention arm according to the randomisation schedule.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/03/2023
Actual
Date of last participant enrolment
Anticipated
30/10/2023
Actual
Date of last data collection
Anticipated
22/12/2023
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 313027 0
Charities/Societies/Foundations
Name [1] 313027 0
Hunter Medical Research Institute
Country [1] 313027 0
Australia
Primary sponsor type
Individual
Name
Dr Hayley Lewthwaite
Address
Organisation: University of Newcastle, College of Health, Medicine and Wellbeing.
Address: Hunter Medical Research Institute, Lot 1, Kookaburra Circuit, New Lambton Heights NSW 2305
Country
Australia
Secondary sponsor category [1] 314719 0
None
Name [1] 314719 0
Address [1] 314719 0
Country [1] 314719 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312289 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 312289 0
Research & Innovation Services
Research Integrity Unit
The University of Newcastle
Callaghan NSW 2308
Ethics committee country [1] 312289 0
Australia
Date submitted for ethics approval [1] 312289 0
Approval date [1] 312289 0
11/08/2022
Ethics approval number [1] 312289 0
H-2022-0091

Summary
Brief summary
Regular exercise helps people with chronic obstructive pulmonary disease (COPD) to remain independent, stay out of hospital and live longer. However, current COPD clinical guidelines don’t provide clear, evidence-based recommendations around what intensity people with COPD should exercise at. Recommendations provided are based on healthy adults and don’t consider the limitations to breathing and high levels of breathlessness experienced by people with COPD. This may mean people with COPD exercise at intensities too high, causing intolerable breathlessness and negative exercise experiences, or too low, not eliciting health benefits. This study will evaluate the benefits of using respiratory-specific parameters to guide exercise prescription in COPD. We will compare the benefits of three, 6-week exercise training groups: (1) usual care, defined as 25 minutes of continuous cycle exercise at a breathlessness intensity of 3 (moderate) to 5 (severe) on Borg's 0-10 category ratio scale; (2) 25 minutes of continuous cycle exercise based on respiratory-specific parameters; (3) high intensity interval exercise training (HIIT, 4 lots of 4 minute exercise periods, interspersed with 3 minute rest periods) based on respiratory-specific parameters. Specifically, this study aims to answer two research questions:
1. Do people with COPD achieve greater adherence and health benefits from 6 weeks of continuous exercise prescribed based on respiratory specific parameters compared with current exercise training practices (usual care)?
2. Is it safe and feasible for people with COPD to perform HIIT prescribed based on respiratory specific parameters, to further maximise health benefits from an exercise training program?

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 124122 0
Dr Hayley Lewthwaite
Address 124122 0
Hunter Medical Research Institute (HMRI)
Lot 1, Kookaburra Circuit New Lambton Heights NSW 2305
Country 124122 0
Australia
Phone 124122 0
+61 0249854582
Fax 124122 0
Email 124122 0
Hayley.Lewthwaite@newcastle.edu.au
Contact person for public queries
Name 124123 0
Dr Hayley Lewthwaite
Address 124123 0
Hunter Medical Research Institute (HMRI)
Lot 1, Kookaburra Circuit New Lambton Heights NSW 2305
Country 124123 0
Australia
Phone 124123 0
+61 0249854582
Fax 124123 0
Email 124123 0
Hayley.Lewthwaite@newcastle.edu.au
Contact person for scientific queries
Name 124124 0
Dr Hayley Lewthwaite
Address 124124 0
Hunter Medical Research Institute (HMRI)
Lot 1, Kookaburra Circuit New Lambton Heights NSW 2305
Country 124124 0
Australia
Phone 124124 0
+61 0249854582
Fax 124124 0
Email 124124 0
Hayley.Lewthwaite@newcastle.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



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.