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Completed

NCT Number: NCT05553119

A Study of Home-based Pulmonary Rehabilitation and Health Coaching to Treat Bronchiectasis

The purpose of this study is to gather information on the effectiveness on a home-based pulmonary rehabilitation in patients with bronchiectasis.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

The purpose of this study is to gather information on the effectiveness on a home-based pulmonary rehabilitation in patients with bronchiectasis. We hope that by participating in home-rehab that patients with bronchiectasis will become more physically active in their daily lives.

Pulmonary Rehabilitation in a medical center has proven to have a positive impact on physical activity and shortness of breath in patients with chronic lung disease. However, travel and access can make going to a center difficult.

Study participation involves completing gentle flexibility exercises and walking practice using a provided computer tablet, pulse oximeter and an activity tracker for 12 weeks. During that time, you will talk to a health coach once a week on the phone. At the end of the 12 weeks, someone will call you and ask you questions about your experience with the home-based rehab. Health Coaching calls will be recorded so that it can later be transcribed. All identifying information will be removed and the answers will be lumped together.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Having a diagnosis of non-cystic fibrosis bronchiectasis (primary inclusion criteria) ,confirmed by records, that are symptomatic.
  • Ability to communicate in English.

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.

Treatment and study plan

Home Rehabilitation Monitoring System

Behavioral

Established home-based pulmonary rehab system consists of three commercial devices (Garmin Vívofit™ activity monitor, Nonin 3150 WristOx2® Pulse Oximeter, Android tablet) and two software applications for telemonitored home pulmonary rehabilitation.

Health coaching calls

Behavioral

Coaching calls based on motivational interviewing principles will occur weekly for twelve weeks following a standard protocol, lasting no more than 5-10 minutes.

Primary outcomes

  1. Change in patient-reported quality of life

    Time frame: Baseline, after completion of the 12-week intervention.

    As defined by the COPD Assessment Test (CAT). The CAT is a validated tool for measuring health status in patients with bronchiectasis and is divided into eight domains of cough, mucous production, chest tightness, shortness of breath with activity, activity limitation at home, confidence leaving home, sleep quality, and energy. A lower score suggests no health-related quality of life (HRQL) impairment, while the maximum score of 40 represents significant impact.

Secondary outcomes

  1. Physical activity

    Time frame: 12 weeks

    As measured by number of steps per 24-hr period.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Home-based Pulmonary Rehabilitation and Health Coaching in Bronchiectasis

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 23, 2022
Registry last updated
Sep 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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