Lung; Disease, Interstitial, With FibrosisNCT03752892
Partitioned Training of Patients With Idiopathic Pulmonary Fibrosis
A study testing intervention -1-leg cycle training in people with Lung; Disease, Interstitial, With Fibrosis, run by West Park Healthcare Centre at 1 site in Canada.
Trial summary
Idiopathic pulmonary fibrosis (IPF) is a lung disease that limits the ability to breathe enough for a good workout. One way to improve the exercise training is to reduce the number of muscles being trained together. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung; Disease, Interstitial, With Fibrosis
- What is being tested?
- intervention -1-leg cycle training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2019to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- confirmed idiopathic pulmonary fibrosis
- Clinically stable
- enrolled in pulmonary rehabilitation
Who cannot join
- co-morbidities that might impair their ability to safely complete a pulmonary rehabilitation program
- complete a pulmonary rehabilitation program within the previous 6 months
- experienced an exacerbation less than six weeks before participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial of Partitioned Aerobic Exercise Training of Patients With Idiopathic Pulmonary Fibrosis
Idiopathic pulmonary fibrosis (IPF) is a lung disease that limits the ability to breathe enough for a good workout. One way to improve the exercise training is to reduce the number of muscles being trained together. By training one leg at a time, the patient does not have to breathe as much allowing each leg a better workout. Our groundwork suggests it may work in patients with IPF. This study will help decide whether one-legged exercise training is better at improving a patient's exercise endurance compared to the usual way of exercising with both legs at the same time.
Read the detailed description
Dyspnea is a major clinical manifestation of idiopathic pulmonary fibrosis (IPF). It becomes more severe and more limiting as the condition progresses. Many professional respiratory societies recommend that the standard of care for IPF includes pulmonary rehabilitation (PR). However, some patients with IPF are so limited by dyspnea that they are unable to tolerate levels of aerobic exercise training sufficient to induce the physiological adaptations that will improve functional and health related outcomes. Therefore, there is a need for exercise training interventions that will enhance the muscle training stimulus above that currently possible in individuals with a marked ventilatory limitation.
Partitioning large muscle exercise using one-legged high intensity training is more effective than conventional aerobic training when applied to patients with central ventilatory or cardiac limitation. Effective partitioned exercise enables an increased muscle load with less ventilatory load. It increases the training stimulus to the muscles as they work at a high intensity, relative to their current aerobic state, necessary to increase their capacity. As long as the active muscle mass can create the same demands on the central exercise components of the heart and circulation as does conventional two-legged exercise, this simple, inexpensive novel approach, will stimulate leg muscles sufficiently to improve overall cardiorespiratory fitness. For example, in those with chronic obstructive pulmonary disease, one-legged training has been shown to provide a muscle specific stimulus sufficient to improve whole body peak oxygen uptake during pulmonary rehabilitation. A preliminary acute study of patients with IPF has demonstrated that during a laboratory simulation of an exercise training session, partitioning aerobic exercise extended exercise tolerance. Participants achieved double the work whilst exercising with one leg compared with two-legged cycle exercise. Partitioned training may therefore be an effective approach to exercise training in patients with IPF enrolled in PR.
The advent of pharmacological agents that stabilize the clinical course of IPF presents a window of opportunity for exercise rehabilitation to further improve function. The aim of this proposed study is to determine whether, within the setting of PR, partitioned aerobic exercise training with a one-legged cycle training regime is more effective than the conventional two-legged regimen in increasing exercise tolerance. The study hypothesis is that partitioned aerobic exercise training, using a one-legged training regime is more effective than conventional two-legged exercise training in increasing exercise tolerance (measured by constant power endurance) and cardiorespiratory fitness as measured by maximal oxygen uptake. The results will inform the best approach to produce clinically meaningful improvements in dyspnea and health status for those with IPF.
- Being tested
- intervention -1-leg cycle training, usual care - 2-leg cycle training
- Keywords
- pulmonary rehabilitation, exercise training
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intervention -1-leg cycle trainingOther
partitioned aerobic exercise training
usual care - 2-leg cycle trainingOther
conventional aerobic exercise training
| Study group | Role | What they receive |
|---|---|---|
| intervention -1-leg cycle training | Experimental | Primary aerobic training component one-legged, partitioned, cycle training. A progressive approach to combined intensity and duration will be taken. A cycle starting with intermittent high intensity one-legged exercise progressing to continuous duration of the target duration of 15 min for each leg and then restarting the cycle at a higher intensity. Receives: Other: intervention -1-leg cycle training |
| usual care - 2-leg cycle training | Active comparator | Primary aerobic training component conventional two-legged cycle training. A progressive approach to combined intensity and duration will be taken. A cycle starting with intermittent high intensity exercise progressing to continuous duration of 30 min and then restarting the cycle at a higher intensity. Receives: Other: usual care - 2-leg cycle training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cycle exercise endurance time
tolerance (time) of a constant power high intensity cycle endurance test
Measured: Change from Baseline at discharge from 8 weeks of pulmonary rehabilitation
Secondary outcomes (1)
health-related quality of life
using the questionnaire 'A Tool to Assess Quality of life in IPF' [ATAQ-IPF]
Measured: Change from Baseline at discharge from 8 weeks of pulmonary rehabilitation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2018
- Study start1 Mar 2019
- Primary completion28 Apr 2025
- Study completion31 Dec 2026 (estimated)
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 Lung; Disease, Interstitial, With FibrosisStudies 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
- Model description
- prospective, randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West Park Healthcare Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roger Goldstein, West Park Healthcare Centre
- Investigators
- Roger S Goldstein, Principal investigator, West Park Healthcare Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03752892
- Sponsor's protocol ID
- 1L-IPF-RCT-RG2018
- Status last verified
- Nov 2025
- First submitted
- 20 Nov 2018
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dolmage TE, Masouleh SK, Ellerton C, Damiao EC, Drazic D, Khalil M, Oliveira A, Varadi R, Shapera S, Evans RA, Goldstein RS. Randomised controlled trial of partitioned aerobic exercise training using one-leg cycling in patients with idiopathic pulmonary fibrosis. Thorax. 2026 Sep 15:thorax-2026-225333. doi: 10.1136/thorax-2026-225333. Online ahead of print.
PubMed 42744588
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Partitioned Aerobic Exercise Training of Patients With Idiopathic Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT03752892
- Acronym / sponsor ID
- 1L-IPF-RCT-RG2018
- Keywords
- pulmonary rehabilitation, exercise training
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- West Park Healthcare CentreUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 28 Apr 2025 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 26 Nov 2018 (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.
Idiopathic pulmonary fibrosis (IPF) is a lung disease that limits the ability to breathe enough for a good workout. One way to improve the exercise training is to reduce the number of muscles being trained together. By training one leg at a time, the patient does not have to breathe as much allowing each leg a better workout. Our groundwork suggests it may work in patients with IPF. This study will help decide whether one-legged exercise training is better at improving a patient's exercise endurance compared to the usual way of exercising with both legs at the same time.
Detailed description
Dyspnea is a major clinical manifestation of idiopathic pulmonary fibrosis (IPF). It becomes more severe and more limiting as the condition progresses. Many professional respiratory societies recommend that the standard of care for IPF includes pulmonary rehabilitation (PR). However, some patients with IPF are so limited by dyspnea that they are unable to tolerate levels of aerobic exercise training sufficient to induce the physiological adaptations that will improve functional and health related outcomes. Therefore, there is a need for exercise training interventions that will enhance the muscle training stimulus above that currently possible in individuals with a marked ventilatory limitation.
Partitioning large muscle exercise using one-legged high intensity training is more effective than conventional aerobic training when applied to patients with central ventilatory or cardiac limitation. Effective partitioned exercise enables an increased muscle load with less ventilatory load. It increases the training stimulus to the muscles as they work at a high intensity, relative to their current aerobic state, necessary to increase their capacity. As long as the active muscle mass can create the same demands on the central exercise components of the heart and circulation as does conventional two-legged exercise, this simple, inexpensive novel approach, will stimulate leg muscles sufficiently to improve overall cardiorespiratory fitness. For example, in those with chronic obstructive pulmonary disease, one-legged training has been shown to provide a muscle specific stimulus sufficient to improve whole body peak oxygen uptake during pulmonary rehabilitation. A preliminary acute study of patients with IPF has demonstrated that during a laboratory simulation of an exercise training session, partitioning aerobic exercise extended exercise tolerance. Participants achieved double the work whilst exercising with one leg compared with two-legged cycle exercise. Partitioned training may therefore be an effective approach to exercise training in patients with IPF enrolled in PR.
The advent of pharmacological agents that stabilize the clinical course of IPF presents a window of opportunity for exercise rehabilitation to further improve function. The aim of this proposed study is to determine whether, within the setting of PR, partitioned aerobic exercise training with a one-legged cycle training regime is more effective than the conventional two-legged regimen in increasing exercise tolerance. The study hypothesis is that partitioned aerobic exercise training, using a one-legged training regime is more effective than conventional two-legged exercise training in increasing exercise tolerance (measured by constant power endurance) and cardiorespiratory fitness as measured by maximal oxygen uptake. The results will inform the best approach to produce clinically meaningful improvements in dyspnea and health status for those with IPF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- prospective, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| intervention -1-leg cycle training | Experimental | Other: intervention -1-leg cycle trainingPrimary aerobic training component one-legged, partitioned, cycle training. A progressive approach to combined intensity and duration will be taken. A cycle starting with intermittent high intensity one-legged exercise progressing to continuous duration of the target duration of 15 min for each leg and then restarting the cycle at a higher intensity. |
| usual care - 2-leg cycle training | Active comparator | Other: usual care - 2-leg cycle trainingPrimary aerobic training component conventional two-legged cycle training. A progressive approach to combined intensity and duration will be taken. A cycle starting with intermittent high intensity exercise progressing to continuous duration of 30 min and then restarting the cycle at a higher intensity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- confirmed idiopathic pulmonary fibrosis
- Clinically stable
- enrolled in pulmonary rehabilitation
Key exclusion criteria (3 listed)
- co-morbidities that might impair their ability to safely complete a pulmonary rehabilitation program
- complete a pulmonary rehabilitation program within the previous 6 months
- experienced an exacerbation less than six weeks before participation
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 |
|---|---|---|
| intervention -1-leg cycle trainingpartitioned aerobic exercise training | Other | intervention -1-leg cycle training |
| usual care - 2-leg cycle trainingconventional aerobic exercise training | Other | usual care - 2-leg cycle training |
Primary outcome
Cycle exercise endurance time
Time frame: Change from Baseline at discharge from 8 weeks of pulmonary rehabilitation
tolerance (time) of a constant power high intensity cycle endurance test
1 secondary outcome
health-related quality of life
Time frame: Change from Baseline at discharge from 8 weeks of pulmonary rehabilitation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Derived from this study: PubMed 42744588Dolmage TE, Masouleh SK, Ellerton C, Damiao EC, Drazic D, Khalil M, Oliveira A, Varadi R, Shapera S, Evans RA, Goldstein RS. Randomised controlled trial of partitioned aerobic exercise training using one-leg cycling in patients with idiopathic pulmonary fibrosis. Thorax. 2026 Sep 15:thorax-2026-225333. doi: 10.1136/thorax-2026-225333. Online ahead of print.
- 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.
Roger S Goldstein principal investigator
West Park Healthcare Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intervention -1-leg cycle training in people with Lung; Disease, Interstitial, With Fibrosis, run by West Park Healthcare Centre at 1 site in Canada.
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 3 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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?
This study is still under way. Results are not available in the source record yet.
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?
Cycle exercise endurance time (time frame: Change from Baseline at discharge from 8 weeks of pulmonary rehabilitation). 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 NCT03752892, 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 20 Aug 2026.