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IPF mHealth Exercise

Study Purpose

Patients with idiopathic pulmonary fibrosis (IPF) who are stable on antifibrotic therapy at least 3 months will be randomized to complete a 12-week home exercise intervention using an mHealth platform, plus a pre- and post-intervention monitoring period (4 weeks each) and in-person study assessments.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 40 Years - 80 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Age 40-80 yrs at randomization.
  • - Diagnosis of idiopathic pulmonary fibrosis (IPF), consistent with the ATS 2018 Guidelines.
  • - Percent Forced Vital Capacity (%FVC) ≥50% and ≤90% - Percent Carbon Monoxide Diffusing Capacity (%DLCO) ≥30% and ≤90% - Willing and able to participate in an exercise regimen.
  • - Ambulatory without the use of an assistive device.
  • - Stable on antifibrotic therapy (pirfenidone or nintedanib) at least 3 months.
  • - No changes in other medication for at least 4 wks before enrollment.
  • - Must be able to read, write, and verbally communicate in English.

Exclusion Criteria:

  • - Forced expiratory volume in one second (FEV1)/FVC ratio <0.7 after administration of bronchodilator at screening.
  • - Expected to receive a lung transplant within 1 year from randomization or, for patients at sites in the United States, on a lung transplant waiting list at randomization.
  • - Known explanation for interstitial lung disease.
  • - History of asthma or chronic obstructive pulmonary disease.
  • - Active infection.
  • - Ongoing IPF treatments including investigational therapy, immunosuppresents (other than prednisone 20 mg daily and below) and cytokine modulating agents.
  • - Participation in a supervised exercise program including pulmonary rehab within the previous 12 months.
  • - History of unstable or deteriorating cardiac or pulmonary disease (other than IPF) within the previous 6 months.
  • - Major orthopedic, psychiatric, neurological, or other conditions that would impair performance of the study exercise outcomes.
  • - Require >5LPM supplemental O2 at rest.
- Currently pregnant

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04838275
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of Washington
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Mary Beth Brown, PT, PhD
Principal Investigator Affiliation University of Washington
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Idiopathic Pulmonary Fibrosis
Additional Details

Contemporary walk test endpoints in IPF trials may under-represent patient functional gains with antifibrotic therapy, which may be more effectively captured with long-term activity monitoring. Traditional pulmonary rehabilitation centers create a barrier to patient exercise accessibility and compliance, which is eliminated in a mobile health (mHealth) exercise training approach. In this study, 30 patients with IPF will be randomized into one of two arms. The exercise arm will receive a 12-week home exercise intervention using an mHealth platform plus pre- and post-intervention monitoring (4 weeks each). The non-exercise arm will be monitored for the same study duration. The primary end point is change from baseline in daily physical activity as a number of weekly exercise minutes qualifying as moderate to vigorous physical activity (MVPA), METS*minutes of exercise per week, and sedentary time minutes. Assessments will be performed primarily via in-person study visits at week 4 and week 16, as well as via daily recordings from mHealth monitoring devices.

Arms & Interventions

Arms

Experimental: Exercise Arm

antifibrotic therapy + mHealth monitoring + 12-wk mHealth home exercise prescription

No Intervention: Non-Exercise Arm

antifibrotic therapy + mHealth monitoring

Interventions

Behavioral: - 12-week mHealth home exercise prescription

3x/week home walking protocol, 2x/week resistance exercise program

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Washington, Seattle, Washington

Status

Recruiting

Address

University of Washington

Seattle, Washington, 98195

Site Contact

Beth Brown, PT, PhD

mbbrown1@uw.edu

206-685-3852