Home Pulmonary Rehabilitation for COPD

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

Official title:

Home Pulmonary Rehabilitation for COPD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03480386
• Other study ID #: 17-009449
• Secondary ID: R01HL140486-01
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: February 16, 2022

Study information

• Verified date: January 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 375
• Est. completion date: February 16, 2022
• Est. primary completion date: February 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 99 Years

Eligibility

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/

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Emphysema
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Behavioral:
• Home Based Pulmonary Rehabilitation
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.

Locations

Country	Name	City	State
United States	Mayo Clinic in Florida	Jacksonville	Florida
United States	Health Partners	Minneapolis	Minnesota
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Benzo R, Hoult J, McEvoy C, Clark M, Benzo M, Johnson M, Novotny P. Promoting Chronic Obstructive Pulmonary Disease Wellness through Remote Monitoring and Health Coaching: A Clinical Trial. Ann Am Thorac Soc. 2022 Nov;19(11):1808-1817. doi: 10.1513/Annals — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Quality of Life	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.	Baseline, 3 months
Secondary	Change in Self-management Abilities	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.	Baseline, 3 months
Secondary	Change in Physical Activity	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 .	Baseline, 3 months
Secondary	Change in Daily Step Counts	Measured by the Actigraph wGT3X-BT worn for 7 days continuously to measure daily step count.	Baseline, 3 months
Secondary	Change in Depression	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.	Baseline, 3 months
Secondary	Social Support	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.	Baseline, 3 months
Secondary	Meaning in Life	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.	Baseline, 3 months
Secondary	Change in Sleep Quality	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.	Baseline, 3 months
Secondary	Change in Anxiety	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.	Baseline, 3 months
Secondary	Healthcare Utilization	Number of subjects to have an emergency room visits or hospitalization.	3 months

External Links

•   Mayo Clinic Clinical Trials