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Home-based Pulmonary Rehabilitation and Health Coaching in Fibrotic Interstitial Lung Disease

Study Purpose

The purpose of this study is to gather information on the effectiveness of a home-based pulmonary rehabilitation program with health coaching and tele-monitoring for improving patient-reported respiratory-related quality of life and physical activity in patients with fibrotic Interstitial Lung Diseases (f-ILD).

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 18 Years - 95 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Diagnosis of idiopathic pulmonary fibrosis (IPF) or other fibrotic interstitial lung disease, with a minimum of > 10% fibrosis on computed tomography imaging.
  • - Clinically meaningful breathlessness: modified Medical Research Council (mMRC) dyspnea score >1.

Exclusion Criteria:

  • - Inability to walk (orthopedic/neurologic/cardiac limitation causing immobility).
  • - Cognitive impairment or inability to understand and follow instructions.
  • - Traditional PR completed within 3 months of study recruitment.
  • - Hospice or end-of-life care at the time of screening.
  • - Acute exacerbation at the time of screening.

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.

NCT05130034
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.

Mayo Clinic
Principal Investigator

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

Teng Moua, MD
Principal Investigator Affiliation Mayo Clinic
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.

Fibrotic Interstitial Lung Disease
Additional Details

The home-based pulmonary rehabilitation program involves using a computer tablet paired with a pulse oximeter and activity tracker. Gentle upper body exercises, walking and a breathing practice are completed by following along on the computer tablet. Weekly check-in calls by telephone will be provided by a Health Coach to assess clinical status and monitor progress. The exercise portion of the program lasts 12 weeks. There are questionnaires and a research grade activity tracker measuring baseline and post-intervention findings at the end of 12-week period.

Arms & Interventions

Arms

Experimental: Home-based pulmonary rehab for fibrotic interstitial lung disease

Subjects diagnosed with fibrotic interstitial lung disease will participate in a home-rehab program that promotes more physical activity in daily life.

Interventions

Behavioral: - Home-based pulmonary rehabilitation

Home-based tablet-assisted pulmonary rehabilitation with monitoring technology and telephonic health coach calls using motivational interviewing techniques

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.

Mayo Clinic in Rochester, Rochester, Minnesota

Status

Recruiting

Address

Mayo Clinic in Rochester

Rochester, Minnesota, 55905