Fibrotic Interstitial Lung DiseaseHIIT in fILDNCT03800914
High Intensity Interval Training in Fibrotic Interstitial Lung Disease
A study testing High intensity interval training and Traditional pulmonary rehabilitation in people with Fibrotic Interstitial Lung Disease, run by Monash University at 4 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibrotic Interstitial Lung Disease
- What is being tested?
- High intensity interval training and Traditional pulmonary rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- 4 sitesAustralia
- Study dates
- 17 Jul 2019to 4 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of fibrotic interstitial lung disease (fILD)
- Able to read and speak English
Who cannot join
- Resting oxygen saturation (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
Trial locations and contacts
4 sites in 1 country.
Australia4 sites
Prince Charles Hospital
Brisbane, Queensland, 4032
Austin Health
Heidelberg, Victoria, 3084
Alfred Health
Melbourne, Victoria, 3004
Royal Prince Alfred Hospital
Sydney, New South Wales, 2050
About this study
Official title: High Intensity Interval Training in Fibrotic Interstitial Lung Disease: a Randomized Controlled Trial
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 (HIIT), 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.
The study will determine to whether HIIT 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. A randomised controlled, assessor blinded trial will be conducted. A total 130 people with fILD will be randomly assigned to moderate intensity continuous training or HIIT. If this trial demonstrates that HIIT is effective, it will provide an exercise training strategy that can readily be implemented in practice that will maximise the outcomes of exercise training for people with fILD.
Read the detailed description
Interstitial lung disease (ILD) is a chronic lung condition characterized by scarring of lung tissue. This stiffening of the lungs impairs breathing and reduces the amount of oxygen being delivered throughout the body limiting the ability to perform daily and physical activity. Around two-thirds of people with ILD have fibrotic ILD (fILD), a type of ILD, which typically has worse impairment and disability than other types of ILD. There is no cure for these conditions, although there are two new pharmacological therapies that slow the decline in lung function in Idiopathic Pulmonary Fibrosis (IPF), the most common type of fILD. These treatments however do not provide improvement in breathlessness, exercise capacity or health-related quality of life (HRQoL).
Exercise training, or Pulmonary Rehabilitation (PR), has shown to be effective at improving exercise tolerance and HRQoL in ILD. The investigators recently demonstrated that, at a group level, exercise training exerts a positive effect across varying subtypes of ILD, including IPF, the most rapidly progressive of all the fILDs. However less than half of those with IPF who undertook the exercise training achieved meaningful improvements in exercise capacity. In addition, a large proportion of people with IPF were unable to keep up with the recommended exercise training level, often due to excessive dyspnoea or desaturation. This suggests the current exercise training strategies used in PR, which were adopted from guidelines for patients with chronic obstructive pulmonary disease (COPD), may not provide the optimal exercise stimuli for fILD. High intensity interval training (HIIT), which is 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. However, it is unknown whether this kind of exercise training achieves superior benefits to the traditional model of PR.
The aim of this project is to determine whether HIIT is better than the current method of continuous exercise training at moderate intensity, in improving exercise capacity, breathlessness and HRQoL in people with fILD. A total 130 people with fILD will be recruited. The trial will be conducted at four hospital sites across Australia. People who agree to take part in the study will be randomly allocated into two groups. Group 1 will undergo the traditional PR model of moderate intensity continuous exercise training and group 2 will undergo HIIT. Participants in both groups will participate in exercise training twice weekly for eight weeks. The participants will be monitored continuously during exercise by an experienced physiotherapist or exercise physiologist. At the beginning and the end of the eight weeks of exercise training, and six months later, participants will undergo measurements of exercise capacity and health status. This study will determine whether HIIT is effective, providing an important exercise training strategy that can be readily used for people with fILD to achieve positive benefits from PR.
- Conditions
- Fibrotic Interstitial Lung Disease
- Being tested
- High intensity interval training, Traditional pulmonary rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High intensity interval trainingOther
36 minutes of interval exercise on cycle ergometer alternating every 30 seconds between 100% peak work rate achieved on cardiopulmonary exercise test and unloaded cycling
Traditional pulmonary rehabilitationOther
30 minutes of continuous exercise on cycle ergometer at 60% peak work rate achieved on cardiopulmonary exercise test.
| Study group | Role | What they receive |
|---|---|---|
| High Intensity Interval Training | Experimental | Participants will undergo a twice-weekly supervised exercise training program for eight weeks. Each session will involve 36 minutes of interval aerobic exercise on a cycle ergometer alternating every 30 seconds between 100% of peak work rate, achieved on the cardiopulmonary exercise test (CPET), plus upper and lower resistance training. Receives: Other: High intensity interval training |
| Traditional pulmonary rehabilitation | Active comparator | Participants will undergo a twice-weekly supervised exercise training program for eight weeks. Each session will involve 30 minutes of continuous aerobic exercise on a cycle ergometer at 60% of the peak work rate achieved on the CPET, plus upper and lower resistance training. Receives: Other: Traditional pulmonary rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in endurance time
Endurance time measured during constant work rate test (CWRT) at 75% of the peak work rate achieved on a baseline cardiopulmonary exercise test (CPET).
Measured: Baseline, nine weeks and 6 months following intervention
Secondary outcomes (10)
Change in dyspnea measured using the Dyspnea-12 questionnaire
Dyspnea-12 is a uni-dimensional 12-item questionnaire divided in 2 domains: physical items (1 to 7) and affective items (8-12). Each item evaluate breathing experience and can be scored as: None (0), Mild (1), Moderate (2) or Severe (3). Results of this questionnaire will be reported as total score that can range from 0 to 36 and separate scores that can range from 0 to 21 for physical component and 0 to 15 for affective component. Higher scores indicate worse dyspnea.
Measured: Baseline, nine weeks and 6 months following intervention
Changes in fatigue evaluated by the Fatigue Severity Scale
Fatigue Severity Scale (FSS), a self reported rating scale including 9 items to measure how fatigue affects motivation, exercise, physical functioning, carrying out duties and how fatigue interferes with work, family, or social life. Each item is scored on a 7 point scale in which 1 = strongly disagree and 7= strongly agree. Total score range from 9 to 63. Higher scores indicate greater fatigue severity.
Measured: Baseline, nine weeks and 6 months following intervention
Change in health related quality of life using the St George's Respiratory Questionnaire idiopathic pulmonary fibrosis specific version (SGRQ-I)
The SGRQ-I is a disease specific HRQoL measure with similar psychometric properties to the original SGRQ that is designed to be more relevant in patients with IPF. The questionnaire is divided in 3 domains: Symptoms (frequency and severity), Activity (activities that cause or are limited by breathlessness) and Impact (social functioning and psychological disturbances resulting from airways disease). Values of each domain as well as the total score value will be reported. Each item is weighted based on empirical data. Total score and scores in each domain can range from 0 to 100. Higher scores indicate more limitations in quality of life.
Measured: Baseline, nine weeks and 6 months following intervention
Change in health related quality of life using the chronic respiratory disease questionnaire (CRQ)
The CRQ consists of 20 items across 4 domains: Dyspnea (activities that cause breathlessness and are performed frequently), fatigue, emotional function and mastery ( the patient's feeling of control over their disease). Each domain includes four to seven items, and each item is scored on a 7-point Likert score. Total scores for each domain range from 4-35. Values of each domain will be reported. Lower scores indicate more limitations in quality of life.
Measured: Baseline, nine weeks and 6 months following intervention
Change in anxiety and depression measured by the Hospital Anxiety and Depression Scale
Hospital Anxiety and Depression Scale (HADS), a scale with 14 items divided into two domains : anxiety symptoms (7 items) and depression symptoms (7 items). Each item can be scored from 0 to 3. Scores from each domain can vary from 0 to 21 and are stratified as follows: 0-7 (indicates absence of anxiety/depression symptoms); 8-10 ( presence of symptoms of anxiety and depression in moderate degree - borderline); 11 or more (significant number of anxiety/depression symptoms - confirmed cases). Score of each domain as well as number of confirmed cases will be reported.
Measured: Baseline, nine weeks and 6 months following intervention
Change in functional exercise capacity assessed by 6-minute walk distance
Distance in meters achieved on a 6-minute walk test
Measured: Baseline, nine weeks and 6 months following intervention
Changes in skeletal muscle size
Change in cross-sectional area of the Quadriceps will be measured by B-mode ultrasonography
Measured: Baseline, nine weeks and 6 months following intervention
Dyspnea related disability - measured with modified medical research council scale (MMRC)
The MMRC rates dyspnea according to different levels activity on a 5-point scale (grade 0-4), with grade 4 representing the greatest level of dyspnea impairment.
Measured: Baseline, nine weeks and 6 months following intervention
Global rating of change
The global rating of change will assess the participants' overall self-perceived change in health by asking the participant to rate their change as either 'worse', 'about the same' or 'better'. The extent of change ( (i.e., worsening or improvement) is then graded on a Likert scale from one to seven.
Measured: Baseline, nine weeks and 6 months following intervention
Change in physical activity
Time spent sedentary and in physical activity of various intensities will be measured by a wrist-worn, tri-axial accelerometer.
Measured: Baseline, nine weeks and 6 months following intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2019
- Study start17 Jul 2019
- Primary completion4 Apr 2024
- Study completion4 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fibrotic Interstitial Lung DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Monash University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne E Holland PhD, FThorSoc, Monash University
- Investigators
- Anne Holland, Study director, Monash University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03800914
- Sponsor's protocol ID
- LTU HIIT in ILD
- Acronym
- HIIT in fILD
- Status last verified
- May 2025
- First submitted
- 9 Jan 2019
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dowman LM, May AK, Hill CJ, Bondarenko J, Spencer L, Morris NR, Alison JA, Walsh J, Goh NSL, Corte T, Glaspole I, Chambers DC, McDonald CF, Holland AE. High intensity interval training versus moderate intensity continuous training for people with interstitial lung disease: protocol for a randomised controlled trial. BMC Pulm Med. 2021 Nov 10;21(1):361. doi: 10.1186/s12890-021-01704-2.
PubMed 34758808
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Intensity Interval Training in Fibrotic Interstitial Lung Disease: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03800914
- Acronym / sponsor ID
- HIIT in fILD / LTU HIIT in ILD
- Conditions
- Fibrotic Interstitial Lung Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Monash UniversityUniversity, hospital or other
- Study start
- 17 Jul 2019 (actual)
- Primary completion
- 4 Apr 2024 (actual)
- Study completion
- 4 Dec 2024 (actual)
- First posted
- 11 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 (HIIT), 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.
The study will determine to whether HIIT 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. A randomised controlled, assessor blinded trial will be conducted. A total 130 people with fILD will be randomly assigned to moderate intensity continuous training or HIIT. If this trial demonstrates that HIIT is effective, it will provide an exercise training strategy that can readily be implemented in practice that will maximise the outcomes of exercise training for people with fILD.
Detailed description
Interstitial lung disease (ILD) is a chronic lung condition characterized by scarring of lung tissue. This stiffening of the lungs impairs breathing and reduces the amount of oxygen being delivered throughout the body limiting the ability to perform daily and physical activity. Around two-thirds of people with ILD have fibrotic ILD (fILD), a type of ILD, which typically has worse impairment and disability than other types of ILD. There is no cure for these conditions, although there are two new pharmacological therapies that slow the decline in lung function in Idiopathic Pulmonary Fibrosis (IPF), the most common type of fILD. These treatments however do not provide improvement in breathlessness, exercise capacity or health-related quality of life (HRQoL).
Exercise training, or Pulmonary Rehabilitation (PR), has shown to be effective at improving exercise tolerance and HRQoL in ILD. The investigators recently demonstrated that, at a group level, exercise training exerts a positive effect across varying subtypes of ILD, including IPF, the most rapidly progressive of all the fILDs. However less than half of those with IPF who undertook the exercise training achieved meaningful improvements in exercise capacity. In addition, a large proportion of people with IPF were unable to keep up with the recommended exercise training level, often due to excessive dyspnoea or desaturation. This suggests the current exercise training strategies used in PR, which were adopted from guidelines for patients with chronic obstructive pulmonary disease (COPD), may not provide the optimal exercise stimuli for fILD. High intensity interval training (HIIT), which is 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. However, it is unknown whether this kind of exercise training achieves superior benefits to the traditional model of PR.
The aim of this project is to determine whether HIIT is better than the current method of continuous exercise training at moderate intensity, in improving exercise capacity, breathlessness and HRQoL in people with fILD. A total 130 people with fILD will be recruited. The trial will be conducted at four hospital sites across Australia. People who agree to take part in the study will be randomly allocated into two groups. Group 1 will undergo the traditional PR model of moderate intensity continuous exercise training and group 2 will undergo HIIT. Participants in both groups will participate in exercise training twice weekly for eight weeks. The participants will be monitored continuously during exercise by an experienced physiotherapist or exercise physiologist. At the beginning and the end of the eight weeks of exercise training, and six months later, participants will undergo measurements of exercise capacity and health status. This study will determine whether HIIT is effective, providing an important exercise training strategy that can be readily used for people with fILD to achieve positive benefits from PR.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Intensity Interval Training | Experimental | Other: High intensity interval trainingParticipants will undergo a twice-weekly supervised exercise training program for eight weeks. Each session will involve 36 minutes of interval aerobic exercise on a cycle ergometer alternating every 30 seconds between 100% of peak work rate, achieved on the cardiopulmonary exercise test (CPET), plus upper and lower resistance training. |
| Traditional pulmonary rehabilitation | Active comparator | Other: Traditional pulmonary rehabilitationParticipants will undergo a twice-weekly supervised exercise training program for eight weeks. Each session will involve 30 minutes of continuous aerobic exercise on a cycle ergometer at 60% of the peak work rate achieved on the CPET, plus upper and lower resistance training. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of fibrotic interstitial lung disease (fILD)
- Able to read and speak English
Key exclusion criteria (7 listed)
- Resting oxygen saturation (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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High intensity interval training36 minutes of interval exercise on cycle ergometer alternating every 30 seconds between 100% peak work rate achieved on cardiopulmonary exercise test and unloaded cycling | Other | High Intensity Interval Training |
| Traditional pulmonary rehabilitation30 minutes of continuous exercise on cycle ergometer at 60% peak work rate achieved on cardiopulmonary exercise test. | Other | Traditional pulmonary rehabilitation |
Primary outcome
Change in endurance time
Time frame: Baseline, nine weeks and 6 months following intervention
Endurance time measured during constant work rate test (CWRT) at 75% of the peak work rate achieved on a baseline cardiopulmonary exercise test (CPET).
10 secondary outcomes
Change in dyspnea measured using the Dyspnea-12 questionnaire
Time frame: Baseline, nine weeks and 6 months following intervention
Changes in fatigue evaluated by the Fatigue Severity Scale
Time frame: Baseline, nine weeks and 6 months following intervention
Change in health related quality of life using the St George's Respiratory Questionnaire idiopathic pulmonary fibrosis specific version (SGRQ-I)
Time frame: Baseline, nine weeks and 6 months following intervention
Change in health related quality of life using the chronic respiratory disease questionnaire (CRQ)
Time frame: Baseline, nine weeks and 6 months following intervention
Change in anxiety and depression measured by the Hospital Anxiety and Depression Scale
Time frame: Baseline, nine weeks and 6 months following intervention
Change in functional exercise capacity assessed by 6-minute walk distance
Time frame: Baseline, nine weeks and 6 months following intervention
Changes in skeletal muscle size
Time frame: Baseline, nine weeks and 6 months following intervention
Dyspnea related disability - measured with modified medical research council scale (MMRC)
Time frame: Baseline, nine weeks and 6 months following intervention
Global rating of change
Time frame: Baseline, nine weeks and 6 months following intervention
Change in physical activity
Time frame: Baseline, nine weeks and 6 months following intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
- Derived from this study: PubMed 34758808Dowman LM, May AK, Hill CJ, Bondarenko J, Spencer L, Morris NR, Alison JA, Walsh J, Goh NSL, Corte T, Glaspole I, Chambers DC, McDonald CF, Holland AE. High intensity interval training versus moderate intensity continuous training for people with interstitial lung disease: protocol for a randomised controlled trial. BMC Pulm Med. 2021 Nov 10;21(1):361. doi: 10.1186/s12890-021-01704-2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Holland study director
Monash University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High intensity interval training and Traditional pulmonary rehabilitation in people with Fibrotic Interstitial Lung Disease, run by Monash University at 4 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in endurance time (time frame: Baseline, nine weeks and 6 months following intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03800914, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025.