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Trial registered on ANZCTR


Registration number
ACTRN12619000019101
Ethics application status
Approved
Date submitted
20/09/2018
Date registered
9/01/2019
Date last updated
9/01/2019
Date data sharing statement initially provided
9/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Benefits of high intensity interval training in people with fibrotic interstitial lung disease
Scientific title
Effect of high intensity interval training on exercise endurance in fibrotic interstitial lung disease
Secondary ID [1] 296148 0
none
Universal Trial Number (UTN)
Trial acronym
HIIT in fILD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fibrotic interstitial lung disease 309745 0
Condition category
Condition code
Respiratory 308547 308547 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
High Intensity Interval training

Participants in will undergo a twice-weekly supervised exercise training program for 8 weeks. The exercise training will occur during the standard pulmonary rehabilitation program of each hospital (Alfred, Austin, Royal Prince Alfred or Prince Charles Hospital). Each session, participants will undertake 36 minutes of stationary cycling; alternating 30 seconds exercise intervals at 100% of peak work rate, achieved on the cardiopulmonary exercise test (CPET), with 30-seconds of unloaded pedalling. Participants will also undertake the same
resistance program as traditional PR.

Exercise training and weekly progressions will be standardised across all sites. Supplemental oxygen will be provided during training if the participant is on long term oxygen therapy or if SpO2 on room air is <85% whilst exercising and accompanied by symptoms and signs of severe hypoxemia. All participants will be encouraged to perform an additional three unsupervised sessions each week of aerobic exercise at an intensity and duration similar to that achieved in the supervised sessions.
Intervention code [1] 312475 0
Rehabilitation
Comparator / control treatment
Traditional Pulmonary Rehabilitation.

Participants will undergo a twice-weekly supervised exercise training program. for 8 weeks. The exercise training will occur during the standard pulmonary rehabilitation program of each hospital (Alfred, Austin, Royal Prince Alfred or Prince Charles Hospital) and will follow the current training methods used in PR. Each session participants will undertake 30 minutes of continuous aerobic exercise on a cycle ergometer. The initial intensity of the stationary cycling will be set at the work rate equivalent to 60% of the peak work rate achieved on the CPET. The resistance training program will comprise lower limb and upper limb dumbbell exercises prescribed as tolerated,to achieve 8-12 repetitions for 2-3 sets of each exercise.

Exercise training and weekly progressions will be standardised across all sites. Supplemental oxygen will be provided during training if the participant is on long term oxygen therapy or if SpO2 on room air is <85% whilst exercising and accompanied by symptoms and signs of severe hypoxemia. All participants will be encouraged to perform an additional three unsupervised sessions each week of aerobic exercise at an intensity and duration similar to that achieved in the supervised sessions.
Control group
Active

Outcomes
Primary outcome [1] 307517 0
Change in endurance time - endurance time will be measured using a constant work rate test (CWRT) at 75% of the peak work rate achieved on a baseline cardiopulmonary exercise test (CPET).
Timepoint [1] 307517 0
Baseline, nine weeks (primary timepoint) and 6 months following intervention
Secondary outcome [1] 352159 0
Change in dyspnea measured using the Dyspnea-12 questionnaire
Timepoint [1] 352159 0
Baseline, nine weeks (post intervention) and 6 months following intervention
Secondary outcome [2] 352160 0
Change in fatigue evaluated by the Fatigue Severity Scale
Timepoint [2] 352160 0
Baseline, nine weeks (post intervention) and 6 months following intervention
Secondary outcome [3] 352162 0
Change in health related quality of life using the St George's Respiratory Questionnaire idiopathic pulmonary fibrosis specific version (SGRQ-I)
Timepoint [3] 352162 0
Baseline, nine weeks (post intervention) and 6 months following intervention
Secondary outcome [4] 352163 0
Change in health related quality of life using the chronic respiratory disease questionnaire (CRQ)

Timepoint [4] 352163 0
Baseline, Nine weeks (post intervention) and 6 months following intervention
Secondary outcome [5] 352164 0
Change in anxiety and depression measured by the Hospital Anxiety and Depression Scale

Timepoint [5] 352164 0
Baseline, nine weeks (post intervention) and 6 months following intervention
Secondary outcome [6] 352165 0
Change in functional exercise capacity assessed by 6-minute walk distance

Timepoint [6] 352165 0
Baseline, nine weeks (post intervention) and 6 months following intervention
Secondary outcome [7] 352166 0
Change in cross-sectional area of the Quadriceps will be measured by B-mode ultrasonography


Timepoint [7] 352166 0
Baseline, nine weeks (post intervention) and 6 months following intervention
Secondary outcome [8] 352167 0
Change in dyspnoea related disability measured with modified medical research council scale (MMRC)

Timepoint [8] 352167 0
Baseline, nine weeks (post intervention) and 6 months following intervention

Secondary outcome [9] 352168 0
Global rating of change scale will be used to assess participants’ overall self-perceived changes with the intervention.

Timepoint [9] 352168 0
nine weeks post baseline (post intervention)
Secondary outcome [10] 355153 0
Change in physical activity measured by the GENEActiv actiwatch (activity monitor)
Timepoint [10] 355153 0
Baseline, nine weeks (post intervention) and 6 months following intervention

Eligibility
Key inclusion criteria
Fibrotic interstitial lung disease
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Resting SpO2 is < 85%
Severe pulmonary hypertension (WHO class IV)
Attendance at Pulmonary rehabilitation (PR) within last 12 months
Comorbidities which preclude exercise training
History of syncope on exertion
Significant cognitive impairment
Anticipated transplant or death within the duration of the study period

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)
The group allocation will be concealed using a secure online database.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence generation will be performed by an individual independent of the research team . A computer generated, permuted block randomisation scheme will be used with stratification for (i) SpO2 less than or equal to 90% during 6-minute walk test on room air and (ii) site of recruitment
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)
Efficacy
Statistical methods / analysis
Continuous variables will be analysed by fitting linear mixed models, controlling for baseline values as required

Recruitment
Recruitment status
Not yet recruiting
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)
NSW,QLD,VIC
Recruitment hospital [1] 11970 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [2] 11971 0
The Alfred - Prahran
Recruitment hospital [3] 11972 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [4] 11973 0
The Prince Charles Hospital - Chermside
Recruitment postcode(s) [1] 24117 0
3084 - Heidelberg
Recruitment postcode(s) [2] 24118 0
3004 - Prahran
Recruitment postcode(s) [3] 24119 0
2050 - Camperdown
Recruitment postcode(s) [4] 24120 0
4032 - Chermside

Funding & Sponsors
Funding source category [1] 300735 0
Other Collaborative groups
Name [1] 300735 0
Centre of research excellence in Pulmonary Fibrosis
Address [1] 300735 0
Centre of Research Excellence in Pulmonary Fibrosis
Respiratory Medicine and Sleep Unit
Level 11, Royal Prince Alfred Hospital
Camperdown NSW 2050
Country [1] 300735 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
La Trobe University/Alfred Health Clinical School
Alfred Centre, Level 4
99 Commercial Rd
Prahran VIC 3181
Country
Australia
Secondary sponsor category [1] 300272 0
None
Name [1] 300272 0
Address [1] 300272 0
Country [1] 300272 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301517 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 301517 0
The Alfred
55 Commercial Rd
Melbourne VIC 3004
Ethics committee country [1] 301517 0
Australia
Date submitted for ethics approval [1] 301517 0
02/10/2018
Approval date [1] 301517 0
13/11/2018
Ethics approval number [1] 301517 0
NMA Approval Certificate 46405

Summary
Brief summary
The fibrotic interstitial lung diseases (fILD) is a group of debilitating chronic lung conditions that are characterised by scarring of lung tissue, dyspnoea on exertion and significant physical impairment. Exercise training is recommended for people with fILD in improving breathlessness and exercise tolerance. However, despite the best efforts of patients and clinicians, many of those who participate are not attaining its benefits. The current exercise training strategies of moderate intensity continuous training may not be well suited to fILD. High intensity interval training, short bouts of high-intensity exercise regularly interspersed with periods of rest or light exercise may be an alternate exercise training option for people with fILD. People with fILD will be recruited and randomly allocated to receive either the traditional PR model of moderate intensity continuous training or high intensity interval training. The aim of this study is to determine to whether high intensity interval training is better than the current method of continuous exercise training at moderate intensity in improving exercise tolerance, breathlessness and quality of life in people with fILD.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 87258 0
Dr Leona Dowman
Address 87258 0
La Trobe University/Alfred Health Clinical School
Alfred Centre, Level 4
99 Commercial Rd
Prahran VIC 3181
Country 87258 0
Australia
Phone 87258 0
+61 423 614 218
Fax 87258 0
Email 87258 0
leona.dowman@austin.org.au
Contact person for public queries
Name 87259 0
Dr Leona Dowman
Address 87259 0
La Trobe University/Alfred Health Clinical School
Alfred Centre, Level 4
99 Commercial Rd
Prahran VIC 3181
Country 87259 0
Australia
Phone 87259 0
+61 423 614 218
Fax 87259 0
Email 87259 0
leona.dowman@austin.org.au
Contact person for scientific queries
Name 87260 0
Dr Leona Dowman
Address 87260 0
La Trobe University/Alfred Health Clinical School
Alfred Centre, Level 4
99 Commercial Rd
Prahran VIC 3181
Country 87260 0
Australia
Phone 87260 0
+61 423 614 218
Fax 87260 0
Email 87260 0
leona.dowman@austin.org.au

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
Not applicable