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Trial registered on ANZCTR


Registration number
ACTRN12619000300178
Ethics application status
Approved
Date submitted
12/02/2019
Date registered
27/02/2019
Date last updated
10/08/2020
Date data sharing statement initially provided
27/02/2019
Date results information initially provided
14/08/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Acute effects of interval training for interstitial lung disease
Scientific title
Acute effects of interval training for interstitial lung disease
Secondary ID [1] 296964 0
None
Universal Trial Number (UTN)
Trial acronym
None
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Interstitial lung disease 310927 0
Condition category
Condition code
Respiratory 309592 309592 0 0
Other respiratory disorders / diseases
Physical Medicine / Rehabilitation 310357 310357 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. A single High-intensity interval training session: 30-second intervals of cycle exercise at 100% of Wpeak alternating with 30-seconds of unloaded pedalling until volitional exhaustion, symptom limitation or desaturation (SpO2 < 80%) or a maximum duration of 45 minutes.
2. A single Moderate-intensity interval training session: 2-minute intervals of cycle exercise at 80% of Wpeak alternating with 2-minute at 40% of Wpeak until volitional exhaustion, symptom limitation or desaturation (SpO2 < 80%) or a maximum duration of 45 minutes.

The cycle training sessions were administered by a physiotherapist and an exercise physiologist. The cycle training sessions were separated by 2-5 days.
Intervention code [1] 313237 0
Treatment: Other
Comparator / control treatment
A single continuous training session: continuous cycle exercise at 60% of Wpeak until volitional exhaustion, symptom limitation or desaturation (SpO2 < 80%) or a maximum duration of 45 minutes.

The cycle training sessions were administered by a physiotherapist and an exercise physiologist. The cycle training sessions were separated by 2-5 days.
Control group
Active

Outcomes
Primary outcome [1] 318551 0
total work performed during the cycle exercise sessions on the cycle ergometer
The total duration of exercise achieved in seconds will by multiplied by the percentage of peak work of the specific test. With the continuous exercise training sessions at 60% peak work, a test lasting 45 minutes will have a total work of 162000
Timepoint [1] 318551 0
End test
Primary outcome [2] 318552 0
nadir oxygen saturation (SpO2) during exercise using hand held pulse oximeter
Timepoint [2] 318552 0
SpO2 will be monitored and recording continually throughout the test. The lowest saturation level (nadir) that occurred during the test will be recorded and used in the data analysis.
Secondary outcome [1] 365363 0
Peak Heart rate measured using polar heart rate monitor

Timepoint [1] 365363 0
Heart Rate will be monitored and recording continually throughout the test. The highest heart rate (peak) that occurred during the test will be recorded and used in the data analysis.
Secondary outcome [2] 365364 0
Peak VO2 measured directly during the cycle training sessions on the cycle ergometer using a portable metabolic monitoring system (MetaMax 3B, Cortex, Germany).
Timepoint [2] 365364 0
End test
Secondary outcome [3] 365365 0
Peak VCO2,measured directly during the cycle training sessions on the cycle ergometer using a portable metabolic monitoring system (MetaMax 3B, Cortex, Germany).

Timepoint [3] 365365 0
Baseline, five minutes and at end exercise
Secondary outcome [4] 365366 0
Total exercise time achieved during the cycle sessions measured in minutes using a stop watch
Timepoint [4] 365366 0
End test
Secondary outcome [5] 367101 0
Peak VE measured directly during the cycle training sessions on the cycle ergometer using a portable metabolic monitoring system (MetaMax 3B, Cortex, Germany).
Timepoint [5] 367101 0
End of test
Secondary outcome [6] 367102 0
Blood lactate measured by finger prick
Timepoint [6] 367102 0
End of Test
Secondary outcome [7] 367103 0
Dyspnoea on Borg scale at end exercise
Timepoint [7] 367103 0
End test
Secondary outcome [8] 367105 0
Leg fatigue on Borg scale at end exercise
Timepoint [8] 367105 0
End Test

Eligibility
Key inclusion criteria
- A diagnosis of ILD
- Oxygen desaturation <90% during 6-minute walk test on room air
- Clinically stable ILD during the 4 preceding weeks as indicated by no history of exacerbation.
- Ability to provide informed consent
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Clinical instability eg syncope or myocardial infarction within the previous 4 weeks
- Comorbidities that limit ability to participate in exercise training or physical activity
- Resting oxygen saturation (SpO2) less than 85% on room air, as supplemental oxygen will not be used during measurement of gas exchange during exercise.

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 not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Analysis data will be reported as mean ± SD. The level of statistical significance will be set at p < 0.05 for all tests. Within and between training comparisons of acute effects in the three exercise trainings will be performed using repeated measures ANOVA, controlling for any period or carryover effects.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 12817 0
The Alfred - Prahran
Recruitment postcode(s) [1] 25287 0
3004 - Prahran

Funding & Sponsors
Funding source category [1] 301534 0
University
Name [1] 301534 0
La Trobe University
Address [1] 301534 0
Level 4, Alfred Centre
99 Commercial Rd
Prahran VIC 3181
Country [1] 301534 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
Level 4, Alfred Centre
99 Commercial Rd
Prahran VIC 3181
Country
Australia
Secondary sponsor category [1] 301686 0
None
Name [1] 301686 0
Address [1] 301686 0
Country [1] 301686 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302272 0
Alfred Hospital ethics Committee
Ethics committee address [1] 302272 0
Alfred Hospital ethics Committee
The Alfred
55 Commercial Rd
Melbourne VIC 3004
Ethics committee country [1] 302272 0
Australia
Date submitted for ethics approval [1] 302272 0
30/01/2017
Approval date [1] 302272 0
27/02/2017
Ethics approval number [1] 302272 0
Project 53/17

Summary
Brief summary
The interstitial lung diseases (ILDs) are a debilitating group of over 200 chronic lung conditions characterised by scarring of the lungs, progressive decline in lung function and few treatment options. Exercise-induced hypoxaemia and dyspnoea on exertion are key features of the ILDs. Pulmonary rehabilitation is a recommended treatment for the ILDs, providing short-term improvements in exercised capacity, symptoms and quality of life following pulmonary rehabilitation. Despite this robust evidence for pulmonary rehabilitation at a group level, only one third of individuals with ILD who undertake PR appear to experience a clinically significant benefit. In our RCT of PR in ILD, thirty-three percent of participants with ILD achieved improvement in 6MWD that exceeded the minimal important difference at the end of PR. The proportion of participants who achieved a clinically significant benefit was slightly greater for those with IPF (42%) and more so for those with asbestosis (55%). Therefore, it appears traditional exercise prescription in PR is inadequate in at least 50% people with ILD. Alternative training strategies may prove more effective in both minimising symptoms and improving exercise tolerance in people with ILD. Interval training (IT) consists of periods of relative high intensity exercise interspersed with periods of low intensity exercise and/or rest. In healthy, interval training induces similar or even superior physiological changes to traditional endurance training. In COPD, interval training delivers equivalent improvements in exercise capacity and quality of life with less dyspnoea and leg discomfort. Whether interval training is tolerable and feasible in patients with ILD is not known. The ideal length of the interval is also unknown. This is a prospective, randomised, crossover trial will investigate the acute physiological effects of high intensity interval cycle training compared to lower intensity interval training and standard continuous training in people with ILD participating in pulmonary rehabilitation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 89650 0
Prof Anne Holland
Address 89650 0
Central Clinical School, Monash University
Level 6, The Alfred Centre
99 Commercial Rd Prahran VIC 3181
Country 89650 0
Australia
Phone 89650 0
+61 3 9903 0214
Fax 89650 0
Email 89650 0
A.holland@latrobe.edu.au
Contact person for public queries
Name 89651 0
Prof Anne Holland
Address 89651 0
Central Clinical School, Monash University
Level 6, The Alfred Centre
99 Commercial Rd Prahran VIC 3181
Country 89651 0
Australia
Phone 89651 0
+61 3 99030214
Fax 89651 0
Email 89651 0
anne.holland@monash.edu
Contact person for scientific queries
Name 89652 0
Prof Anne Holland
Address 89652 0
Central Clinical School, Monash University
Level 6, The Alfred Centre
99 Commercial Rd Prahran VIC 3181
Country 89652 0
Australia
Phone 89652 0
+61 3 99030214
Fax 89652 0
Email 89652 0
anne.holland@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data for this study will collected and kept in re-identifiable (coded) information. The code can be accessed only by the Investigators. Group data only will be presented in conference papers or publications of this research. If an instance arises where availability of individual participant data is required, it will be made available in a deidentified form with oversight of the appropriate HREC.
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary