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mHealth Exercise Program for Idiopathic Pulmonary Fibrosis
N/A
Recruiting
Led By Mary Beth Brown, PT, PhD
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 4, week 16, week 20
Awards & highlights
Study Summary
This trial will test if an mHealth platform can help patients with idiopathic pulmonary fibrosis who are stable on antifibrotic therapy to exercise at home.
Who is the study for?
This trial is for adults aged 40-80 with idiopathic pulmonary fibrosis (IPF) who have been stable on antifibrotic drugs for at least 3 months. Participants must be able to exercise, communicate in English, and not expect a lung transplant within a year. Those with recent unstable heart or lung disease, other causes of lung fibrosis, or using high oxygen support (>5LPM) can't join.Check my eligibility
What is being tested?
The study tests a 12-week home exercise program delivered through an mHealth platform for IPF patients. It includes monitoring periods before and after the intervention and requires in-person assessments to evaluate its effectiveness.See study design
What are the potential side effects?
Since this trial involves an exercise regimen rather than medication, side effects may include typical exercise-related issues such as muscle soreness or fatigue but should generally be minimal.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 4, week 16, week 20
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 4, week 16, week 20
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Daily Physical Activity
Secondary outcome measures
Borg Rating of Perceived Dyspnea Scale
Cardiopulmonary Exercise Testing (CPET)
IPF-specific version of the St. George Respiratory Questionnaire (SGRQ-I)
+7 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Exercise ArmExperimental Treatment1 Intervention
antifibrotic therapy + mHealth monitoring + 12-wk mHealth home exercise prescription
Group II: Non-Exercise ArmActive Control1 Intervention
antifibrotic therapy + mHealth monitoring
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Who is running the clinical trial?
University of WashingtonLead Sponsor
1,743 Previous Clinical Trials
1,847,840 Total Patients Enrolled
7 Trials studying Idiopathic Pulmonary Fibrosis
1,112 Patients Enrolled for Idiopathic Pulmonary Fibrosis
Genentech, Inc.Industry Sponsor
1,541 Previous Clinical Trials
568,113 Total Patients Enrolled
10 Trials studying Idiopathic Pulmonary Fibrosis
2,820 Patients Enrolled for Idiopathic Pulmonary Fibrosis
Mary Beth Brown, PT, PhDPrincipal InvestigatorUniversity of Washington
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a known reason for having lung disease.You currently have an infection.You have a history of asthma or chronic lung disease.You are planning to get a lung transplant within the next year, or you are already on a waiting list for a lung transplant in the United States.Your lung function is not good, even after using a bronchodilator.Your lung function test shows that your carbon monoxide diffusing capacity is between 30% and 90%.You have participated in a supervised exercise program, such as pulmonary rehab, in the last 12 months.You have significant health conditions that would make it difficult for you to do the study exercises.You are currently receiving treatments for idiopathic pulmonary fibrosis, except for prednisone at a dose of 20 mg per day or less.You need more than 5 liters per minute of extra oxygen when resting.You must be between 40 and 80 years old when the study starts.You have been diagnosed with idiopathic pulmonary fibrosis according to specific medical guidelines.You can walk without needing help from a device like a cane or walker.Your lung function, measured as percent forced vital capacity, should be between 50% and 90%.
Research Study Groups:
This trial has the following groups:- Group 1: Exercise Arm
- Group 2: Non-Exercise Arm
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there an age restriction for particicpants in this experiment?
"The recruitment criteria for this study necessitate that potential participants must be between 40 and 80 years in age."
Answered by AI
Are there particular subjects that would be best suited for this experiment?
"The study is recruiting 30 participants between the ages of 40-80 with usual interstitial pneumonia who are mobile without assistance, willing to exercise regularly, and haven't made any changes in medication for 4 weeks prior."
Answered by AI
Is access to this medical experimentation presently being provided?
"The clinical trial is currently accepting enrolments. The posting was initially published on April 1st 2021 and the details were most recently amended on October 4th 2021, as evidenced by information hosted on clinicaltrials.gov"
Answered by AI
What is the maximum capacity of participants in this clinical trial?
"Affirmative. The information hosted on clinicaltrials.gov verifies that this research effort, initially posted on April 1st 2021, is still accepting enrollees. A total of 30 participants must be found to join the trial from a single site."
Answered by AI
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