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Trial registered on ANZCTR
Registration number
ACTRN12617001271392
Ethics application status
Approved
Date submitted
29/08/2017
Date registered
4/09/2017
Date last updated
27/02/2020
Date data sharing statement initially provided
16/01/2019
Date results information initially provided
27/02/2020
Type of registration
Prospectively registered
Titles & IDs
Public title
Effects of high intensity interval training on exercise capacity in people with cystic fibrosis
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Scientific title
Effects of high intensity interval training on exercise capacity in people with cystic fibrosis: a randomised controlled trial
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Secondary ID [1]
290943
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Nil known
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Universal Trial Number (UTN)
U1111-1194-2987
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Trial acronym
CFIIT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cystic fibrosis (CF)
301673
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Condition category
Condition code
Respiratory
301381
301381
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0
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Other respiratory disorders / diseases
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Physical Medicine / Rehabilitation
303907
303907
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0
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Physiotherapy
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Human Genetics and Inherited Disorders
303908
303908
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0
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Cystic fibrosis
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
High intensity interval training (HIIT): in addition to usual care, participants allocated to the experimental group will be asked to complete an 8 week cycling-based HIIT program. Each training session will involve a 2 minute ‘warm up’, followed by a 30 second ‘work’ phase and 30 second ‘rest’ period (low intensity cycling ~15W), repeated 6 times. The work to rest periods will be followed by a 2 minute ‘cool down’ period. Therefore, the total training time per session will be 10 minutes. Each session will be supervised by a physiotherapist who is trained in the management of people with CF. The training program will commence with a ‘lead in’ phase which will involve 2 sessions of HIIT in weeks 1 and 2. Thereafter, between weeks 3 and 8, HIIT will be undertaken 3 times a week (i.e. total 22 sessions over 8 weeks). The training intensity will be prescribed using measurements of maximum work rate (Wmax) achieved during the ramp-based cycle ergometry test completed during the baseline assessment period. Specifically, the Wmax 'work' phase goal will be 60% for the first training session and 80% by the 4th training session (i.e. the end of week 2). Thereafter, training intensity will be increased as rapidly as symptoms permit. All HIIT sessions will be conducted on the same model of stationary bike (Orbit Eco Generator Interval Bike OEB2002).
Participants will be asked if they experience any post-exercise muscle soreness of the quadriceps femoris the next day following the first training session each week. Those who report experiencing post-exercise muscle soreness will be asked to rate its severity using a visual analogue scale.
The tolerance (attendance of the session and completion of the sessions) of the HIIT sessions will be recorded throughout the 8 week period.
At the beginning, mid-way through and at the end of the training period, participants will be asked to complete HIIT sessions in the same laboratory used to conduct the ramp-based cycle ergometry test. During these sessions, cardiorespiratory and symptom responses will be recorded.
The HIIT sessions will be audio recorded for evaluation of fidelity if required and review of behaviour change techniques.
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Intervention code [1]
296885
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Treatment: Other
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Intervention code [2]
297841
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Rehabilitation
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Comparator / control treatment
In addition to usual care, participants allocated to the control group will be contacted once a week for 8 weeks by a physiotherapist to discuss changes to their symptoms, healthcare utilisation and participation in exercise over the preceding week. Participants will be allowed to choose the way in which this contact is made; phone calls, texts or emails. If a participant allocated to the control group reports any symptoms that are suggestive of an exacerbation, they will be referred to the CF team for medical review.
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Control group
Active
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Outcomes
Primary outcome [1]
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Exercise endurance (time to symptom limitation during a cycling-based constant work rate test [Tlim]). Time to symptom limitation will be defined as the time it takes from when a participant starts cycling (at 80% of their Wmax on a an ergometer), to when they are unable to continue cycling due to intolerable symptoms of breathlessness or muscle fatigue.
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Assessment method [1]
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Timepoint [1]
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Baseline (pre-randomisation) and follow-up (i.e. following the 8 week intervention) assessment periods
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Secondary outcome [1]
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Exercise capacity (peak oxygen uptake [VO2peak])
Measured via breath-by-breath analysis during an incremental/ramp-based cycle-ergometry test to volitional exhaustion.
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Assessment method [1]
330831
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Timepoint [1]
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Baseline (pre-randomisation) and follow-up (i.e. following the 8 week intervention) assessment periods
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Secondary outcome [2]
330832
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Health-related quality of life will be measured using two questionnaires (Cystic Fibrosis Questionnaire-Revised [CFQ-R] and the Alfred Wellness Score for Cystic Fibrosis [AweScore-CF])
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Assessment method [2]
330832
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Timepoint [2]
330832
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Baseline (pre-randomisation) and follow-up (i.e. following the 8 week intervention) assessment periods
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Secondary outcome [3]
330833
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Exercise Self-Efficacy (Barriers Self-Efficacy Questionnaire [BARSE])
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Assessment method [3]
330833
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Timepoint [3]
330833
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Baseline (pre-randomisation) and follow-up (i.e. following the 8 week intervention) assessment periods
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Secondary outcome [4]
330834
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Feelings of Anxiety and Depression (Hospital Anxiety and Depression Scale [HADS])
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Assessment method [4]
330834
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Timepoint [4]
330834
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Baseline (pre-randomisation) and follow-up (i.e. following the 8 week intervention) assessment periods
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Secondary outcome [5]
330835
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Enjoyment (Physical Activity Enjoyment Scale [PACES])
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Assessment method [5]
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Timepoint [5]
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Baseline (pre-randomisation) and follow-up (i.e. following the 8 week intervention) assessment periods
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Secondary outcome [6]
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Post-exercise muscle soreness
This will be measured 24 hours following the first HIIT session each week in the intervention group only. The participant will be asked if they have any exercise muscle soreness, and if so, to rate the level of soreness of a visual analogue scale (VAS) during one sit-to-stand movement.
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Assessment method [6]
332786
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Timepoint [6]
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24 hours following the first high intensity interval training session each week in the intervention group only
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Secondary outcome [7]
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Tolerance will incorporate attendance and completion of the HIIT session and adverse events, recorded throughout the 8 week period. Adverse events will be categorised as minor, if they are transient and self-limiting events (i.e. breathlessness without significant oxygen desaturation [< 4 % from the participant’s pre-exercise SpO2], muscle or general fatigue) or major events if they require the participant to cease training during any given session or necessitate medical assistance (i.e. breathlessness with significant oxygen desaturation [= 4 % from the participants pre-exercise SpO2], pain, vasovagal events or haemoptysis)
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Assessment method [7]
332795
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Timepoint [7]
332795
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Throughout the 8 week period in the intervention group only (i.e. at every planned HIIT session, the physiotherapist will record if the participant was present, if they were able to complete the HIIT in its entirety and whether there were any adverse events)
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Secondary outcome [8]
335289
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Cardiorespiratory and symptom responses
Measured by completing one HIIT session at the beginning, middle and end of the intervention period on a cycle-ergometer with the addition of breath-by-breath analysis, heart rate, blood pressure and oxygen saturation monitoring. Breathlessness and leg muscle fatigue scores will be taken at the end of each 'work' and 'rest' phase using a modified Borg scale.
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Assessment method [8]
335289
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Timepoint [8]
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In the intervention group only, these sessions will replace one HIIT session at the beginning (week 1), middle (week 4) and end (week 8) of the intervention period
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Secondary outcome [9]
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Qualitative analysis of behaviour change techniques
High intensity interval training sessions will be audio recorded, unless a participant 'opts out'. This audio recording will allow for review of the sessions and qualitative coding of the data, specifically, any techniques utilised during the sessions that may influence adherence.
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Assessment method [9]
337190
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Timepoint [9]
337190
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In the intervention group only, throughout the intervention period (i.e. all HIIT sessions will be audio recorded)
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Eligibility
Key inclusion criteria
People with CF aged 15 years or older and have a body mass index (BMI) > 16 kg/m2 will be eligible to participate.
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Minimum age
15
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
(i) A current or recent (within the previous 4 weeks) exacerbation of CF which required oral or intravenous antibiotics; (ii) a co-morbid condition that would impact on the ability to undertake a maximal incremental exercise capacity test; (iii) poorly controlled diabetes as deemed by their treating endocrinologist; (iv) a previous lung transplant or current listing for lung transplantation; (v) individuals who have consistently trained at a moderate intensity 2 or more times per week for the previous 3 months and; (vi) the inability to provide written informed consent due to a cognitive impairment or being unable to understand English.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment will be completed via the NHMRC randomisation service. This will be completed following the baseline assessment period.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random sequence generation will be completed via the NHMRC randomisation service using a minimisation technique. Participants will be stratified according to hospital site of recruitment (i.e. adult or adolescent), severity of disease and use of Ivacaftor.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
Intention to treat analysis will be used
Participants will be recruited from the outpatient CF clinic at Sir Charles Gairdner Hospital and Perth Children's Hospital.
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Data will be analysed using SPSS. Normality will be checked and a p value of < 0.05 will be considered statistically significant.
To address the primary aim of this randomised controlled trial (i.e. differences between the intervention and control group), between-group differences in all outcomes will be assessed using linear mixed models. Baseline measures will be used as a covariate and group allocations will be used as a fixed factor.
To address the secondary aims, descriptive statistics (secondary aims 1 and 2) or an analysis of variance or Friedman's test (secondary aim 3) will be used. NVivo software will be used to analyse behaviour change techniques.
A sample size of 40 participants is required for this study.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
11/09/2017
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Actual
29/09/2017
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Date of last participant enrolment
Anticipated
26/07/2019
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Actual
4/10/2019
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Date of last data collection
Anticipated
4/10/2019
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Actual
20/12/2019
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Sample size
Target
40
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Accrual to date
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Final
14
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Recruitment in Australia
Recruitment state(s)
WA
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Recruitment hospital [1]
7331
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Sir Charles Gairdner Hospital - Nedlands
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Recruitment hospital [2]
7677
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Princess Margaret Hospital - Subiaco
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Recruitment hospital [3]
8650
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Perth Children's Hospital - Nedlands
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Recruitment postcode(s) [1]
15112
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6009 - Nedlands
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Recruitment postcode(s) [2]
15113
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6009 - Broadway Nedlands
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Recruitment postcode(s) [3]
15595
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6008 - Subiaco
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Funding & Sponsors
Funding source category [1]
295362
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Other Collaborative groups
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Name [1]
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Institute for Respiratory Health - Conquer Cystic Fibrosis Research Trust
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Address [1]
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Level 2, QQ Block, QE11 Medical Centre
6 Verdun Street, Nedlands, WA, 6009
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Country [1]
295362
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Australia
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Funding source category [2]
297064
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Hospital
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Name [2]
297064
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Sir Charles Gairdner Hospital
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Address [2]
297064
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Research Advisory Committee
Sir Charles Gairdner and Osborne Park Health Care Group (SCGOPHCG) Department of Research
Sir Charles Gairdner Hospital
Hospital Ave, Nedlands, WA, 6009
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Country [2]
297064
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Australia
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Funding source category [3]
297065
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University
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Name [3]
297065
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Curtin University - Australian Government Research Training Program Scholarship
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Address [3]
297065
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Kent Street, Bentley, WA, 6012
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Country [3]
297065
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Australia
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Funding source category [4]
297066
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Charities/Societies/Foundations
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Name [4]
297066
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Australian Cystic Fibrosis Research Trust
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Address [4]
297066
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Cystic Fibrosis Australia
Rose Cottage
2 Richardson Place, North Ryde, NSW, 2113
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Country [4]
297066
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Australia
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Primary sponsor type
Other Collaborative groups
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Name
Institute for Respiratory Health - Conquer Cystic Fibrosis Research Program
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Address
Level 2, QQ Block, QE11 Medical Centre
6 Verdun Street, Nedlands, WA, 6009
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Country
Australia
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Secondary sponsor category [1]
294188
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University
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Name [1]
294188
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Curtin University - Australian Government Research Training Program Scholarship
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Address [1]
294188
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Kent Street, Bentley, WA, 6102
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Country [1]
294188
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Australia
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Secondary sponsor category [2]
294807
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Hospital
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Name [2]
294807
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Sir Charles Gairdner Hospital
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Address [2]
294807
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Hospital Avenue, Nedlands, WA, 6009
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Country [2]
294807
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
297211
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Sir Charles Gairdner Hospital Human Research Ethics Committee
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Ethics committee address [1]
297211
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Hospital Avenue, Nedlands, WA, 6009
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Ethics committee country [1]
297211
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Australia
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Date submitted for ethics approval [1]
297211
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24/05/2017
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Approval date [1]
297211
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09/06/2017
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Ethics approval number [1]
297211
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RGS0000000065
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Summary
Brief summary
Currently, exercise guidelines for people with cystic fibrosis (CF) recommend 30 to 60 minutes of aerobic exercise on most days; a recommendation that is consistent with that provided for the general population. In addition to the usual demands on a person’s time such as work, study and family, people with CF have a high daily treatment burden involving airway clearance, medical and nutritional treatment, which are can take up to 4 hours per day to be completed. Therefore, completing 30 to 60 minutes of exercise per day can be difficult to achieve. A novel training approach, such as high intensity interval training (HIIT) may represent a more efficient option to increase exercise capacity. High intensity interval training has been demonstrated to improve exercise capacity in healthy individuals, as well as people with chronic respiratory disease. The main benefit of HIIT is the reduced time commitment, compared to other forms of exercise training. Currently, there are no guidelines for the use of HIIT in people with CF. The proposed PhD will, in people with CF, implement a HIIT program in a supervised setting over an 8 week period to investigate the effects of the program on exercise capacity, health-related quality of life (HRQoL), exercise self-efficacy, feelings of anxiety, depression, enjoyment and muscle oxidative capacity. It will also report on: (i) the proportion of participants who develop post-exercise muscle soreness and the severity of these symptoms; (ii) the tolerance of the HIIT program; (iii) the cardiorespiratory and symptom responses to HIIT over the 8 week program and; (iv) the behaviour change techniques. We hypothesize that in people with CF, 8 weeks of supervised HIIT will change exercise capacity, HRQoL, exercise self-efficacy, enjoyment and muscle oxidative capacity over and above any change seen with usual care.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Ms Abbey Sawyer
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Address
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Physiotherapy Department, A Block
Sir Charles Gairdner Hospital
Hospital Ave, Nedlands, WA, 6009
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Country
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Australia
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Phone
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+61 8 6457 7981
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Fax
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Email
71798
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[email protected]
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Contact person for public queries
Name
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Ms Abbey Sawyer
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Address
71799
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Physiotherapy Department, A Block
Sir Charles Gairdner Hospital
Hospital Ave, Nedlands, WA, 6009
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Country
71799
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Australia
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Phone
71799
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+61 8 6457 7981
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Fax
71799
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Email
71799
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[email protected]
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Contact person for scientific queries
Name
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Ms Abbey Sawyer
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Address
71800
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Physiotherapy Department, A Block
Sir Charles Gairdner Hospital
Hospital Ave, Nedlands, WA, 6009
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Country
71800
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Australia
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Phone
71800
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+61 8 6457 7981
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Fax
71800
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Email
71800
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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
Source
Title
Year of Publication
DOI
Embase
Endurance cycle ergometry tests performed at a sub-maximal work rate elicit peak physiological and symptom responses in adults with cystic fibrosis.
2021
https://dx.doi.org/10.1111/imj.15408
Embase
Effects of high intensity interval training on exercise capacity in people with cystic fibrosis: Study protocol for a randomised controlled trial.
2018
https://dx.doi.org/10.1186/s13102-018-0108-2
N.B. These documents automatically identified may not have been verified by the study sponsor.
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