Idiopathic Pulmonary FibrosisNCT01118221
Rehabilitation of Idiopathic Pulmonary Fibrosis (IPF) Patients
A study testing pulmonary rehabilitation in people with Idiopathic Pulmonary Fibrosis, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
The incidence and prevalence of IPF increase exponentially with age, and IPF occurs more often in older males. Cigarette smoking and environmental dust exposures are known risk factors for developing IPF. For example, the recently deployed military population, as it ages, is at especially increased risk of IPF. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- pulmonary rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Sep 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical presentation consistent with IPF with onset between three months and 48 months prior to screening.
- Diagnosis made by high-resolution computed tomographic scan showing highly probable IPF.
- Absence of severe pulmonary hypertension (i.e., PAsys must be less than 55 mm Hg, based on echocardiography) and absence of decompensated right heart failure (NYHA class I or II acceptable).
- Age 40 through 80, inclusive.
- Abnormal pulmonary function tests (FVC 40-90% predicted or DLCO 30-90% predicted or impaired gas exchange with rest or exercise).
- Six-minute walk distance 150 m and 500 m.
Show all 9Show fewer
- Worsening as demonstrated by any one of the following within the past year: > 10% decrease in percent predicted forced vital capacity or worsening dyspnea at rest or upon exertion, based on history.
- Ability to understand and sign a written informed consent form and comply with the requirements of the study.
- Absence of clinical features suggesting infection, neoplasm, sarcoidosis or collagen-vascular disease.
Who cannot join
- Echocardiographic evidence of severe pulmonary hypertension (PAsys>55 mm Hg, based on echocardiography or TR velocity 3.2 m/sec).
- Severe heart failure (NYHA class III or IV or LVEF < 45%).
- Six-minute walk distance < 150 m or > 500 m.
- FEV1/FVC ratio < 0.7 at screening (post-bronchodilator).
- Residual volume > 100% predicted.
- Any condition other than IPF likely to result in the death of the participant within the next two years.
Show all 12Show fewer
- History of unstable or deteriorating cardiac or neurologic disease.
- Pregnancy or lactation. Patients who are: (a) pregnant or (b) breast feeding are excluded from the study.
- Current treatment with corticosteroids (either oral or inhaled), Cytoxan, azathioprine, colchicine, pirfenidone, anti-tumor necrosis factor therapy or endothelin receptor blockers. Prior treatment is permitted, but at least four weeks of treatment washout prior to inclusion in this study are required.
- Investigational therapy for any indication within 28 days prior to enrollment.
- Degenerative arthritis, cerebrovascular accident or other limitation to mobility preventing completion of the 6-minute walk test.
- Oxygen saturation on room air <80% at rest.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rehabilitation of IPF Patients: Effects of Exercise and Oxidant Stress
The incidence and prevalence of IPF increase exponentially with age, and IPF occurs more often in older males. Cigarette smoking and environmental dust exposures are known risk factors for developing IPF. For example, the recently deployed military population, as it ages, is at especially increased risk of IPF. No effective therapies exist, although lung transplantation is used to extend survival of selected patients.
Defining specific therapy to improve exercise tolerance and dyspnea in IPF patients is thus an urgent priority of veteran-oriented research programs.
Read the detailed description
Chronic lung disease is common in the veteran population. While chronic obstructive pulmonary disease (COPD) is most prominent, fibrotic lung diseases, typified by idiopathic pulmonary fibrosis (IPF), are clearly increasing. We have developed extensive experience with a VA idiopathic pulmonary fibrosis (IPF) population in the context of a randomized, controlled clinical trial of vasodilator therapy.
Based on the current literature and our preliminary experience with exercise testing in IPF patients, we hypothesize that:
- Formal pulmonary rehabilitation (i.e., an aerobic exercise program) will result in improved outcomes for IPF patients, demonstrable as an:
- Increase in exercise tolerance as quantified by 6-minute walk test (MWT) distance;
- Decrease in post-exercise dyspnea as quantified by the Borg dyspnea scale; and an
- Overall subjective improvement in quality of life as quantified by Saint George's Respiratory Questionnaire.
- Metabolic and physiologic mechanisms of improved exercise tolerance and decreased dyspnea will include:
- More efficient oxygen metabolism demonstrated by maximum O2 uptake (VO2max);
- Decreased post-exercise oxidant stress demonstrated by post-exercise isoprostanes and plasma total antioxidant capacity (TAC); and,
- Maintenance of maximum inspiratory and expiratory pressures (PInmax and PExmax).
Our Specific Objectives are:
- To investigate formal pulmonary rehabilitation and exercise tolerance in IPF patients The following important endpoints will be assessed to test the working hypothesis that pulmonary rehabilitation improves exercise capacity and lessens dyspnea:
- 6-MWT distance;
- Dyspnea index; and,
- Quality of life (Saint George's Respiratory Questionnaire [SGRQ] and International Physical Activity Questionnaire [IPAQ]).
- To assess changes in oxygen uptake, markers of oxidant stress and pulmonary function resulting from pulmonary rehabilitation
To test the working hypothesis that improved outcomes are associated with more efficient O2 utilization, decreased markers of oxidant stress and maintained effort dependent pulmonary function, the following variables will be measured:
- Peak oxygen uptake (VO2peak) during constant load exercise;
- Markers of oxidant stress, including plasma and urine isoprostanes; and,
- Maximum inspiratory and expiratory pressures (PInmax and PExmax). Completion of these Specific Objectives will position our research group to conduct future studies of 1) mechanisms of exercise limitation and 2) antioxidant therapies, both in this defined population and those who are at risk of developing pulmonary fibrosis. The long term impact of this application is thus to develop effective pulmonary rehabilitation strategies for IPF patients, based on knowledge of underlying changes in oxygen metabolism and oxidant stress.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- pulmonary rehabilitation
- Keywords
- oxidant stress, exercise
- Medical subject headings
- Idiopathic Pulmonary Fibrosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pulmonary rehabilitationBehavioural
structured exercise program
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | enroll in pulmonary rehabilitation program Receives: Behavioral: pulmonary rehabilitation |
| Arm 2 | No intervention | no structured exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 Minute Walk Distance
Change in 6 Minute Walk Distance from Baseline to 3 Months
Measured: The 6-MWD will be measured at 0 and 3 months.
Secondary outcomes (2)
Systemic Markers of Oxidant Stress
Plasma F2-isoprostanes measured in all subjects before and after exercise testing at baseline.
Measured: Markers of oxidant stress will be measured in all subjects before randomization after exercise testing at 0 months.
Maximum Oxygen Uptake
Change in 6 peak O2 uptake from Baseline to 3 Months
Measured: Maximum O2 uptake will be measured at 0 and 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2010 (estimated)
- Study startOct 2010
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Pulmonary 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
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Robert M Jackson, MD, Principal investigator, VA Medical Center, Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01118221
- Sponsor's protocol ID
- O7467-R
- Status last verified
- Feb 2015
- First submitted
- 27 Apr 2010
- Last updated
- 4 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Jackson RM, Gomez-Marin OW, Ramos CF, Sol CM, Cohen MI, Gaunaurd IA, Cahalin LP, Cardenas DD. Exercise limitation in IPF patients: a randomized trial of pulmonary rehabilitation. Lung. 2014 Jun;192(3):367-76. doi: 10.1007/s00408-014-9566-9. Epub 2014 Apr 5.
PubMed 24705678Gaunaurd IA, Gomez-Marin OW, Ramos CF, Sol CM, Cohen MI, Cahalin LP, Cardenas DD, Jackson RM. Physical activity and quality of life improvements of patients with idiopathic pulmonary fibrosis completing a pulmonary rehabilitation program. Respir Care. 2014 Dec;59(12):1872-9. doi: 10.4187/respcare.03180. Epub 2014 Sep 2.
PubMed 25185149
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation of IPF Patients: Effects of Exercise and Oxidant Stress
- ClinicalTrials.gov ID
- NCT01118221
- Acronym / sponsor ID
- O7467-R
- Conditions
- Idiopathic Pulmonary Fibrosis
- Keywords
- oxidant stress, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Oct 2010
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 6 May 2010 (estimated)
- Results
- Posted 16 Jan 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The incidence and prevalence of IPF increase exponentially with age, and IPF occurs more often in older males. Cigarette smoking and environmental dust exposures are known risk factors for developing IPF. For example, the recently deployed military population, as it ages, is at especially increased risk of IPF. No effective therapies exist, although lung transplantation is used to extend survival of selected patients.
Defining specific therapy to improve exercise tolerance and dyspnea in IPF patients is thus an urgent priority of veteran-oriented research programs.
Detailed description
Chronic lung disease is common in the veteran population. While chronic obstructive pulmonary disease (COPD) is most prominent, fibrotic lung diseases, typified by idiopathic pulmonary fibrosis (IPF), are clearly increasing. We have developed extensive experience with a VA idiopathic pulmonary fibrosis (IPF) population in the context of a randomized, controlled clinical trial of vasodilator therapy.
Based on the current literature and our preliminary experience with exercise testing in IPF patients, we hypothesize that:
- Formal pulmonary rehabilitation (i.e., an aerobic exercise program) will result in improved outcomes for IPF patients, demonstrable as an:
- Increase in exercise tolerance as quantified by 6-minute walk test (MWT) distance;
- Decrease in post-exercise dyspnea as quantified by the Borg dyspnea scale; and an
- Overall subjective improvement in quality of life as quantified by Saint George's Respiratory Questionnaire.
- Metabolic and physiologic mechanisms of improved exercise tolerance and decreased dyspnea will include:
- More efficient oxygen metabolism demonstrated by maximum O2 uptake (VO2max);
- Decreased post-exercise oxidant stress demonstrated by post-exercise isoprostanes and plasma total antioxidant capacity (TAC); and,
- Maintenance of maximum inspiratory and expiratory pressures (PInmax and PExmax).
Our Specific Objectives are:
- To investigate formal pulmonary rehabilitation and exercise tolerance in IPF patients The following important endpoints will be assessed to test the working hypothesis that pulmonary rehabilitation improves exercise capacity and lessens dyspnea:
- 6-MWT distance;
- Dyspnea index; and,
- Quality of life (Saint George's Respiratory Questionnaire [SGRQ] and International Physical Activity Questionnaire [IPAQ]).
- To assess changes in oxygen uptake, markers of oxidant stress and pulmonary function resulting from pulmonary rehabilitation
To test the working hypothesis that improved outcomes are associated with more efficient O2 utilization, decreased markers of oxidant stress and maintained effort dependent pulmonary function, the following variables will be measured:
- Peak oxygen uptake (VO2peak) during constant load exercise;
- Markers of oxidant stress, including plasma and urine isoprostanes; and,
- Maximum inspiratory and expiratory pressures (PInmax and PExmax). Completion of these Specific Objectives will position our research group to conduct future studies of 1) mechanisms of exercise limitation and 2) antioxidant therapies, both in this defined population and those who are at risk of developing pulmonary fibrosis. The long term impact of this application is thus to develop effective pulmonary rehabilitation strategies for IPF patients, based on knowledge of underlying changes in oxygen metabolism and oxidant stress.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Behavioral: pulmonary rehabilitationenroll in pulmonary rehabilitation program |
| Arm 2 | No intervention | –no structured exercise |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Clinical presentation consistent with IPF with onset between three months and 48 months prior to screening.
- Diagnosis made by high-resolution computed tomographic scan showing highly probable IPF.
- Absence of severe pulmonary hypertension (i.e., PAsys must be less than 55 mm Hg, based on echocardiography) and absence of decompensated right heart failure (NYHA class I or II acceptable).
- Age 40 through 80, inclusive.
- Abnormal pulmonary function tests (FVC 40-90% predicted or DLCO 30-90% predicted or impaired gas exchange with rest or exercise).
Key exclusion criteria (12 listed)
- Echocardiographic evidence of severe pulmonary hypertension (PAsys>55 mm Hg, based on echocardiography or TR velocity 3.2 m/sec).
- Severe heart failure (NYHA class III or IV or LVEF < 45%).
- Six-minute walk distance < 150 m or > 500 m.
- FEV1/FVC ratio < 0.7 at screening (post-bronchodilator).
- Residual volume > 100% predicted.
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 |
|---|---|---|
| pulmonary rehabilitationstructured exercise program | Behavioural | Arm 1 |
Primary outcome
6 Minute Walk Distance
Time frame: The 6-MWD will be measured at 0 and 3 months.
Change in 6 Minute Walk Distance from Baseline to 3 Months
2 secondary outcomes
Systemic Markers of Oxidant Stress
Time frame: Markers of oxidant stress will be measured in all subjects before randomization after exercise testing at 0 months.
Maximum Oxygen Uptake
Time frame: Maximum O2 uptake will be measured at 0 and 3 months.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24705678Jackson RM, Gomez-Marin OW, Ramos CF, Sol CM, Cohen MI, Gaunaurd IA, Cahalin LP, Cardenas DD. Exercise limitation in IPF patients: a randomized trial of pulmonary rehabilitation. Lung. 2014 Jun;192(3):367-76. doi: 10.1007/s00408-014-9566-9. Epub 2014 Apr 5.
- Results publication: PubMed 25185149Gaunaurd IA, Gomez-Marin OW, Ramos CF, Sol CM, Cohen MI, Cahalin LP, Cardenas DD, Jackson RM. Physical activity and quality of life improvements of patients with idiopathic pulmonary fibrosis completing a pulmonary rehabilitation program. Respir Care. 2014 Dec;59(12):1872-9. doi: 10.4187/respcare.03180. Epub 2014 Sep 2.
Related trials for Idiopathic Pulmonary Fibrosis
RecruitingPhase 2
Study to Evaluate the Efficacy, Safety, and Tolerability of PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
RecruitingPhase 2
An Extension Study of Subjects Who Received an Avalyn Inhaled Antifibrotic Agent (SAIL)
Progressive Pulmonary Fibrosis, Idiopathic Pulmonary Fibrosis (IPF)
RecruitingObservational study
Real-world Study of Nerandomilast in Patients With Idiopathic Pulmonary Fibrosis and Progressive Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis (IPF), Progressive Pulmonary Fibrosis
RecruitingPhase 2
A Phase 2 Study of LTI-03 in Patients With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis (IPF)
Not yet recruitingPhase 2
A Phase 2 Study of HB0056 in Patients With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis (IPF)
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.
Robert M Jackson, MD principal investigator
VA Medical Center, Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pulmonary rehabilitation in people with Idiopathic Pulmonary Fibrosis, run by US Department of Veterans Affairs at 1 site in United States.
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 9 inclusion and 12 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 4 Mar 2015. 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 United States. 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?
Yes. Results are posted in the registry (first posted 16 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
6 Minute Walk Distance (time frame: The 6-MWD will be measured at 0 and 3 months.). 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 NCT01118221, which also lists 2 linked publications.
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 4 Mar 2015.