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OpenTrials
Completed

NCT Number: NCT03480386

Home Pulmonary Rehabilitation for COPD

Regular physical activity has been found to be important in maintaining health and well-being in people with COPD. The purpose of this study is to test new technology and health coaching aimed to help people with COPD become more physically active in their daily lives.

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Key information

Age range

40 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Florida, Jacksonville, Florida, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Clinical diagnosis of COPD, confirmed by spirometry
  • Age ≥40 years (to avoid recruiting participants with asthma rather than COPD)
  • Current or previous smoker (≥10 packs per year)
  • Confidence in using the proposed pulmonary rehabilitation (PR) system
  • English language fluency

Exclusion criteria

  • Study candidate experiencing an acute COPD exacerbation (can be included after the acute event)
  • Inability to walk (orthopedic-neurologic problems or confined to a bed)
  • Currently in PR or finished PR in the last three months (unlikely to improve)
  • Pregnant women
  • Live in an area where cell phones do not work/

Treatment and study plan

Home Based Pulmonary Rehabilitation

Behavioral

Twice daily exercise routine six days a week of 3 minutes of personal breathing, 5 exercises with 10 reps each, and 6 minutes of walking with weekly health coach calls.

Primary outcomes

  1. Change in Quality of Life

    Time frame: Baseline, 3 months

    The Chronic Respiratory Questionnaire (CRQ) is a validated tool, completed by participants at baseline and 3 months and measured health-related quality of life. This questionnaire measures both physical and emotional aspects of chronic respiratory disease. All scores have a range of 1 to 7, a higher number being better health-related quality of life. We reported the difference between baseline and 3 months on the CRQ emotional summary score (comprised of the mastery and emotional domains) and the physical summary score (comprised of dyspnea and fatigue domains). 0.5 points is the minimal clinically important difference for this tool.

Secondary outcomes

  1. Change in Self-management Abilities

    Time frame: Baseline, 3 months

    Measured using the Self-Management Ability Scale-30 item questionnaire to assess ability and function. The SMAS consists of 30 items on four- and five-point Likert scales. Total score ranging from 0 to 100 with higher score indicating a higher function and ability, better outcome.

  2. Change in Physical Activity

    Time frame: Baseline, 3 months

    The change in average daily activity (measured in minutes) for the top 3 to 5 most active days during the measured period. Measured by the Actigraph GT3X .

  3. Change in Daily Step Counts

    Time frame: Baseline, 3 months

    Measured by the Actigraph wGT3X-BT worn for 7 days continuously to measure daily step count.

  4. Change in Depression

    Time frame: Baseline, 3 months

    Measured by the Patient Health Questionnaire-9 item questionnaire screening for depression. Total score range from 0 to 27. A higher score indicates that depression may be present.

  5. Social Support

    Time frame: Baseline, 3 months

    Measured by the Interpersonal Support Evaluation List (ISEL-12) a 12-item measure of perceptions of social support utilizing three different subscales designed to measure three dimensions of f perceived social support (appraisal support, beloning support, and tangible support). Each dimension is measured by 4 items on a 4-point scale ranging from "Definitely True" to "Definitely False". Total score range 0-36 with a higher score indicating greater social support.

  6. Meaning in Life

    Time frame: Baseline, 3 months

    Meaning in Life Questionnaire- 10 item questionnaire measuring the purpose, meaning and presence in life. A higher score indicates a perception of higher meaning and purpose. Scores range from 10-70, a higher score indicates a high perceived meaning and purpose in the respondents life.

  7. Change in Sleep Quality

    Time frame: Baseline, 3 months

    Measured using the Pittsburgh Sleep Quality Index to assess severity of sleep disturbances. 9 item questionnaire with total possible scores range from 0 to 21. A lower score suggests a better quality of sleep and a higher score indicates a worse outcome/more severe symptoms of disturbance.

  8. Change in Anxiety

    Time frame: Baseline, 3 months

    Measured using the General Anxiety Disorder-2 item Questionnaire screening for anxiety. Score ranges from 0 to 6.,A higher score suggests that anxiety is present.

  9. Healthcare Utilization

    Time frame: 3 months

    Number of subjects to have an emergency room visits or hospitalization.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

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

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Mar 29, 2018
Registry last updated
Feb 13, 2024

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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