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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
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of high intensity interval training on exercise capacity in people with cystic fibrosis
Scientific title
Effects of high intensity interval training on exercise capacity in people with cystic fibrosis: a randomised controlled trial
Secondary ID [1] 290943 0
Nil known
Universal Trial Number (UTN)
U1111-1194-2987
Trial acronym
CFIIT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cystic fibrosis (CF) 301673 0
Condition category
Condition code
Respiratory 301381 301381 0 0
Other respiratory disorders / diseases
Physical Medicine / Rehabilitation 303907 303907 0 0
Physiotherapy
Human Genetics and Inherited Disorders 303908 303908 0 0
Cystic fibrosis

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 296885 0
Treatment: Other
Intervention code [2] 297841 0
Rehabilitation
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.
Control group
Active

Outcomes
Primary outcome [1] 300779 0
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.
Timepoint [1] 300779 0
Baseline (pre-randomisation) and follow-up (i.e. following the 8 week intervention) assessment periods
Secondary outcome [1] 330831 0
Exercise capacity (peak oxygen uptake [VO2peak])
Measured via breath-by-breath analysis during an incremental/ramp-based cycle-ergometry test to volitional exhaustion.
Timepoint [1] 330831 0
Baseline (pre-randomisation) and follow-up (i.e. following the 8 week intervention) assessment periods
Secondary outcome [2] 330832 0
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])
Timepoint [2] 330832 0
Baseline (pre-randomisation) and follow-up (i.e. following the 8 week intervention) assessment periods
Secondary outcome [3] 330833 0
Exercise Self-Efficacy (Barriers Self-Efficacy Questionnaire [BARSE])
Timepoint [3] 330833 0
Baseline (pre-randomisation) and follow-up (i.e. following the 8 week intervention) assessment periods
Secondary outcome [4] 330834 0
Feelings of Anxiety and Depression (Hospital Anxiety and Depression Scale [HADS])
Timepoint [4] 330834 0
Baseline (pre-randomisation) and follow-up (i.e. following the 8 week intervention) assessment periods
Secondary outcome [5] 330835 0
Enjoyment (Physical Activity Enjoyment Scale [PACES])
Timepoint [5] 330835 0
Baseline (pre-randomisation) and follow-up (i.e. following the 8 week intervention) assessment periods

Secondary outcome [6] 332786 0
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.
Timepoint [6] 332786 0
24 hours following the first high intensity interval training session each week in the intervention group only
Secondary outcome [7] 332795 0
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)
Timepoint [7] 332795 0
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)
Secondary outcome [8] 335289 0
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.
Timepoint [8] 335289 0
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
Secondary outcome [9] 337190 0
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.
Timepoint [9] 337190 0
In the intervention group only, throughout the intervention period (i.e. all HIIT sessions will be audio recorded)

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



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 concealment will be completed via the NHMRC randomisation service. This will be completed following the baseline assessment period.
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.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
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.
Phase
Not Applicable
Type of endpoint/s
Efficacy
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.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
11/09/2017
Actual
29/09/2017
Date of last participant enrolment
Anticipated
26/07/2019
Actual
4/10/2019
Date of last data collection
Anticipated
4/10/2019
Actual
20/12/2019
Sample size
Target
40
Accrual to date
Final
14
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 7331 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [2] 7677 0
Princess Margaret Hospital - Subiaco
Recruitment hospital [3] 8650 0
Perth Children's Hospital - Nedlands
Recruitment postcode(s) [1] 15112 0
6009 - Nedlands
Recruitment postcode(s) [2] 15113 0
6009 - Broadway Nedlands
Recruitment postcode(s) [3] 15595 0
6008 - Subiaco

Funding & Sponsors
Funding source category [1] 295362 0
Other Collaborative groups
Name [1] 295362 0
Institute for Respiratory Health - Conquer Cystic Fibrosis Research Trust
Country [1] 295362 0
Australia
Funding source category [2] 297064 0
Hospital
Name [2] 297064 0
Sir Charles Gairdner Hospital
Country [2] 297064 0
Australia
Funding source category [3] 297065 0
University
Name [3] 297065 0
Curtin University - Australian Government Research Training Program Scholarship
Country [3] 297065 0
Australia
Funding source category [4] 297066 0
Charities/Societies/Foundations
Name [4] 297066 0
Australian Cystic Fibrosis Research Trust
Country [4] 297066 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Institute for Respiratory Health - Conquer Cystic Fibrosis Research Program
Address
Level 2, QQ Block, QE11 Medical Centre
6 Verdun Street, Nedlands, WA, 6009
Country
Australia
Secondary sponsor category [1] 294188 0
University
Name [1] 294188 0
Curtin University - Australian Government Research Training Program Scholarship
Address [1] 294188 0
Kent Street, Bentley, WA, 6102
Country [1] 294188 0
Australia
Secondary sponsor category [2] 294807 0
Hospital
Name [2] 294807 0
Sir Charles Gairdner Hospital
Address [2] 294807 0
Hospital Avenue, Nedlands, WA, 6009
Country [2] 294807 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297211 0
Sir Charles Gairdner Hospital Human Research Ethics Committee
Ethics committee address [1] 297211 0
Ethics committee country [1] 297211 0
Australia
Date submitted for ethics approval [1] 297211 0
24/05/2017
Approval date [1] 297211 0
09/06/2017
Ethics approval number [1] 297211 0
RGS0000000065

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

Contacts
Principal investigator
Name 71798 0
Ms Abbey Sawyer
Address 71798 0
Physiotherapy Department, A Block
Sir Charles Gairdner Hospital
Hospital Ave, Nedlands, WA, 6009
Country 71798 0
Australia
Phone 71798 0
+61 8 6457 7981
Fax 71798 0
Email 71798 0
[email protected]
Contact person for public queries
Name 71799 0
Abbey Sawyer
Address 71799 0
Physiotherapy Department, A Block
Sir Charles Gairdner Hospital
Hospital Ave, Nedlands, WA, 6009
Country 71799 0
Australia
Phone 71799 0
+61 8 6457 7981
Fax 71799 0
Email 71799 0
[email protected]
Contact person for scientific queries
Name 71800 0
Abbey Sawyer
Address 71800 0
Physiotherapy Department, A Block
Sir Charles Gairdner Hospital
Hospital Ave, Nedlands, WA, 6009
Country 71800 0
Australia
Phone 71800 0
+61 8 6457 7981
Fax 71800 0
Email 71800 0
[email protected]

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
SourceTitleYear of PublicationDOI
EmbaseEffects of high intensity interval training on exercise capacity in people with cystic fibrosis: Study protocol for a randomised controlled trial.2018https://dx.doi.org/10.1186/s13102-018-0108-2
EmbaseEndurance cycle ergometry tests performed at a sub-maximal work rate elicit peak physiological and symptom responses in adults with cystic fibrosis.2021https://dx.doi.org/10.1111/imj.15408
N.B. These documents automatically identified may not have been verified by the study sponsor.