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Physical Activity and Pulmonary Rehabilitation for Interstitial Lung Disease (Actigraphy Trial)
N/A
Recruiting
Research Sponsored by Debabrata Bandyopadhyay
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects must be able to walk >150 meters in their screening 6MWT
Recently diagnosed (within 24 months) patients with PF-ILD, including IPF, as defined in the 'study population'
Must not have
Symptomatic moderate to severe valvular heart disease
Morbid obesity, defined as BMI>35
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 52 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial will measure physical activity of IPF/PF-ILD patients to predict disease progression and explore if it affects quality of life, fatigue, and pulmonary function.
Who is the study for?
This trial is for adults over 40 with certain types of lung scarring diseases who can walk more than 150 meters and have not been on anti-scarring lung medication for long. They must be able to do a pulmonary rehab program, have specific levels of lung function, and agree to use contraception if applicable.
What is being tested?
The study tests how daily physical activity measured by an accelerometer affects the quality of life and disease progression in patients starting anti-fibrotic therapy and pulmonary rehabilitation. It will check if increased activity relates to better walking distance, fatigue, breathlessness scores, X-ray findings, and lung function tests.
What are the potential side effects?
While the study focuses on physical activity's impact rather than drug side effects directly, participants may experience side effects from anti-fibrotic medications like diarrhea, liver issues or bleeding risks associated with nintedanib.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can walk more than 150 meters without stopping.
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I was diagnosed with a lung scarring disease within the last 2 years.
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I am 40 or older and have moderate difficulty with physical activity.
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I agree to complete a lung rehab program during the study.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have serious heart valve problems causing symptoms.
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My BMI is over 35.
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My autoimmune disease limits my ability to move around.
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My oxygen levels drop below 88% with activity even when I use extra oxygen.
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I agree to use effective birth control during and for 3 months after nintedanib treatment.
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I cannot or do not want to undergo the necessary tests.
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I need full-dose blood thinners or cannot take nintedanib due to other reasons.
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My heart's pumping ability is significantly reduced.
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I have severe fatigue due to sarcoidosis.
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I have moderate to severe liver problems.
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I cannot walk due to my condition.
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I am experiencing symptoms of a heart attack.
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I haven't had a lung infection or sudden worsening of my lung condition in the last 3 months.
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I have a history of blood clots, bleeding risks, or gut perforations.
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I have severe pulmonary hypertension needing strong medication.
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I have heart disease that causes me symptoms.
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I am currently being treated for cancer that has spread and it affects my ability to move.
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My CT scan shows I have significant emphysema.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 52 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 52 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
change in six-minute walk distance from baseline to 52 weeks
Secondary study objectives
Change in Accelerometer Measurements
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Find a Location
Who is running the clinical trial?
Debabrata BandyopadhyayLead Sponsor
University of South FloridaLead Sponsor
427 Previous Clinical Trials
192,561 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't used antifibrotic drugs or have been on them for less than 3 months.I can walk more than 150 meters without stopping.My BMI is over 35.I have been on antifibrotic therapy for my lung condition for over 6 months.I have severe or very severe COPD.I need full-dose blood thinners or cannot take nintedanib due to other reasons.My autoimmune disease limits my ability to move around.My heart's pumping ability is significantly reduced.My oxygen levels drop below 88% with activity even when I use extra oxygen.I agree to use effective birth control during and for 3 months after nintedanib treatment.I have completed lung rehab for PF-ILD or IPF within the last year.I cannot or do not want to undergo the necessary tests.I was diagnosed with a lung scarring disease within the last 2 years.I have severe fatigue due to sarcoidosis.I have serious heart valve problems causing symptoms.I have moderate to severe liver problems.I cannot walk due to my condition.I am experiencing symptoms of a heart attack.I haven't had a lung infection or sudden worsening of my lung condition in the last 3 months.I have a history of blood clots, bleeding risks, or gut perforations.I have severe pulmonary hypertension needing strong medication.I have heart disease that causes me symptoms.You need to have a certain level of lung function as measured by breathing tests.I am 40 or older and have moderate difficulty with physical activity.I agree to complete a lung rehab program during the study.I am currently being treated for cancer that has spread and it affects my ability to move.My CT scan shows I have significant emphysema.
Research Study Groups:
This trial has the following groups:Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.