Trial Outcomes & Findings for Home Pulmonary Rehabilitation for COPD (NCT NCT03480386)

NCT ID: NCT03480386

Last Updated: 2024-02-13

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 375 participants
• Primary outcome timeframe: Baseline, 3 months
• Results posted on: 2024-02-13

Participant Flow

Participant milestones

Measure	Pulmonary Rehabilitation Program Intervention Subjects will receive 12 weeks home pulmonary rehabilitation (PR) with health coaching. 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.	Usual Care Subjects will receive 12 weeks of usual care.
Overall Study STARTED	188	187
Overall Study COMPLETED	143	142
Overall Study NOT COMPLETED	45	45

Reasons for withdrawal

Measure	Pulmonary Rehabilitation Program Intervention Subjects will receive 12 weeks home pulmonary rehabilitation (PR) with health coaching. 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.	Usual Care Subjects will receive 12 weeks of usual care.
Overall Study Did not complete measures at 3-months	17	14
Overall Study No baseline measures	11	14
Overall Study Death	0	5
Overall Study Withdrawal by Subject	12	8
Overall Study Lost to Follow-up	2	1
Overall Study Complicating disease	0	1
Overall Study Disease progression	3	0
Overall Study Became ineligible	0	2

Baseline Characteristics

Home Pulmonary Rehabilitation for COPD

Baseline characteristics by cohort

Measure	Pulmonary Rehabilitation Program Intervention n=188 Participants Subjects will receive 12 weeks home pulmonary rehabilitation (PR) with health coaching. 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.	Usual Care n=187 Participants Subjects will receive 12 weeks of usual care.	Total n=375 Participants Total of all reporting groups
Age, Continuous	69.335 years STANDARD_DEVIATION 9.530 • n=5 Participants	68.676 years STANDARD_DEVIATION 9.530 • n=7 Participants	69 years STANDARD_DEVIATION 9 • n=5 Participants
Sex: Female, Male Female	101 Participants n=5 Participants	111 Participants n=7 Participants	212 Participants n=5 Participants
Sex: Female, Male Male	87 Participants n=5 Participants	76 Participants n=7 Participants	163 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	181 Participants n=5 Participants	181 Participants n=7 Participants	362 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Race/Ethnicity, Customized White	177 Participants n=5 Participants	180 Participants n=7 Participants	357 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Race/Ethnicity, Customized Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized American Indian/Alaska Native	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian/Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized More than One Race	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment United States	188 participants n=5 Participants	187 participants n=7 Participants	375 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 3 months

Population: Intent-to-treat analyses, if a month three measure is missing for any reason, it will be described as not changing from baseline.

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.

Outcome measures

Measure	Pulmonary Rehabilitation Program Intervention n=142 Participants Subjects will receive 12 weeks home pulmonary rehabilitation (PR) with health coaching. 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.	Usual Care n=142 Participants Subjects will receive 12 weeks of usual care.
Change in Quality of Life CRQ Physical	0.37 score on a scale Interval 0.24 to 0.51	-0.17 score on a scale Interval -0.29 to 0.05
Change in Quality of Life CRQ Emotional	0.43 score on a scale Interval 0.29 to 0.57	-0.08 score on a scale Interval -0.2 to 0.05

SECONDARY outcome

Timeframe: Baseline, 3 months

Population: Intent-to-treat analyses, if a month three measure is missing for any reason, it will be described as not changing from baseline.

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.

Outcome measures

Measure	Pulmonary Rehabilitation Program Intervention n=144 Participants Subjects will receive 12 weeks home pulmonary rehabilitation (PR) with health coaching. 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.	Usual Care n=142 Participants Subjects will receive 12 weeks of usual care.
Change in Self-management Abilities	3.84 score on a scale Interval 2.44 to 5.24	0.54 score on a scale Interval -0.62 to 1.71

SECONDARY outcome

Timeframe: Baseline, 3 months

Population: Intent-to-treat analyses, if a month three measure is missing for any reason, it will be described as not changing from baseline.

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 .

Outcome measures

Measure	Pulmonary Rehabilitation Program Intervention n=128 Participants Subjects will receive 12 weeks home pulmonary rehabilitation (PR) with health coaching. 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.	Usual Care n=138 Participants Subjects will receive 12 weeks of usual care.
Change in Physical Activity Daily Light Physical Activity	17.51 minutes Interval 4.54 to 30.49	0.6 minutes Interval -13.22 to 14.42
Change in Physical Activity Daily Moderate Physical Activity	4.47 minutes Interval -3.17 to 12.11	-4.82 minutes Interval -11.66 to 2.01

SECONDARY outcome

Timeframe: Baseline, 3 months

Population: Intent-to-treat analyses, if a month three measure is missing for any reason, it will be described as not changing from baseline.

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

Outcome measures

Measure	Pulmonary Rehabilitation Program Intervention n=128 Participants Subjects will receive 12 weeks home pulmonary rehabilitation (PR) with health coaching. 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.	Usual Care n=138 Participants Subjects will receive 12 weeks of usual care.
Change in Daily Step Counts	478.63 steps/day Interval 108.02 to 849.25	-146.53 steps/day Interval -458.5 to 165.44

SECONDARY outcome

Timeframe: Baseline, 3 months

Population: Intent-to-treat analyses, if a month three measure is missing for any reason, it will be described as not changing from baseline.

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.

Outcome measures

Measure	Pulmonary Rehabilitation Program Intervention n=144 Participants Subjects will receive 12 weeks home pulmonary rehabilitation (PR) with health coaching. 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.	Usual Care n=142 Participants Subjects will receive 12 weeks of usual care.
Change in Depression	-1.12 score on a scale Interval -1.67 to -0.58	0.08 score on a scale Interval -0.46 to 0.62

SECONDARY outcome

Timeframe: Baseline, 3 months

Population: Intent-to-treat analyses, if a month three measure is missing for any reason, it will be described as not changing from baseline.

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.

Outcome measures

Measure	Pulmonary Rehabilitation Program Intervention n=142 Participants Subjects will receive 12 weeks home pulmonary rehabilitation (PR) with health coaching. 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.	Usual Care n=139 Participants Subjects will receive 12 weeks of usual care.
Social Support	0.58 score on a scale Interval -0.16 to 1.32	-0.04 score on a scale Interval -0.72 to 0.63

SECONDARY outcome

Timeframe: Baseline, 3 months

Population: Intent-to-treat analyses, if a month three measure is missing for any reason, it will be described as not changing from baseline.

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.

Outcome measures

Measure	Pulmonary Rehabilitation Program Intervention n=144 Participants Subjects will receive 12 weeks home pulmonary rehabilitation (PR) with health coaching. 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.	Usual Care n=140 Participants Subjects will receive 12 weeks of usual care.
Meaning in Life	0.07 score on a scale Interval -0.68 to 0.82	-0.33 score on a scale Interval -1.13 to 0.48

SECONDARY outcome

Timeframe: Baseline, 3 months

Population: Intent-to-treat analyses, if a month three measure is missing for any reason, it will be described as not changing from baseline.

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.

Outcome measures

Measure	Pulmonary Rehabilitation Program Intervention n=100 Participants Subjects will receive 12 weeks home pulmonary rehabilitation (PR) with health coaching. 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.	Usual Care n=114 Participants Subjects will receive 12 weeks of usual care.
Change in Sleep Quality	-0.72 score on a scale Interval -1.09 to -0.34	0.03 score on a scale Interval -0.36 to 0.42

SECONDARY outcome

Timeframe: Baseline, 3 months

Population: Intent-to-treat analyses, if a month three measure is missing for any reason, it will be described as not changing from baseline.

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.

Outcome measures

Measure	Pulmonary Rehabilitation Program Intervention n=144 Participants Subjects will receive 12 weeks home pulmonary rehabilitation (PR) with health coaching. 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.	Usual Care n=142 Participants Subjects will receive 12 weeks of usual care.
Change in Anxiety	-0.42 score on a scale Interval -0.68 to -0.15	-0.24 score on a scale Interval -0.57 to 0.09

SECONDARY outcome

Timeframe: 3 months

Population: 46 in the intervention arm were not included in the analysis, 27 withdrew consent, 18 did not complete measures at 3-month and 1 did not complete baseline measures. 45 in the usual care arm were not included in the analysis, 26 withdrew consent, 5 died, and 14 did not complete 3-month measures.

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

Outcome measures

Measure	Pulmonary Rehabilitation Program Intervention n=142 Participants Subjects will receive 12 weeks home pulmonary rehabilitation (PR) with health coaching. 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.	Usual Care n=142 Participants Subjects will receive 12 weeks of usual care.
Healthcare Utilization Any Emergency Room Visit	13 Participants	24 Participants
Healthcare Utilization Any Hospitalization	15 Participants	15 Participants

Adverse Events

Pulmonary Rehabilitation Program Intervention

Serious events: 15 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care

Serious events: 15 serious events

Other events: 0 other events

Deaths: 5 deaths

Serious adverse events

Measure	Pulmonary Rehabilitation Program Intervention n=188 participants at risk Subjects will receive 12 weeks home pulmonary rehabilitation (PR) with health coaching. 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.	Usual Care n=187 participants at risk Subjects will receive 12 weeks of usual care.
Respiratory, thoracic and mediastinal disorders Hospitalization- COPD Exacerbation	4.8% 9/188 • Number of events 14 • Adverse events were collected from baseline to end of study participation for a total of approximately 9 months on all participants. This study tracked emergency room and hospitalizations for all causes. None of the ER visits or hospitalizations or deaths were related to this study.	5.3% 10/187 • Number of events 16 • Adverse events were collected from baseline to end of study participation for a total of approximately 9 months on all participants. This study tracked emergency room and hospitalizations for all causes. None of the ER visits or hospitalizations or deaths were related to this study.
Cardiac disorders Hospitalization: Aortic Stenosis	0.53% 1/188 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 9 months on all participants. This study tracked emergency room and hospitalizations for all causes. None of the ER visits or hospitalizations or deaths were related to this study.	0.00% 0/187 • Adverse events were collected from baseline to end of study participation for a total of approximately 9 months on all participants. This study tracked emergency room and hospitalizations for all causes. None of the ER visits or hospitalizations or deaths were related to this study.
General disorders Hospitalization: Opioid Hyperalgesia	0.53% 1/188 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 9 months on all participants. This study tracked emergency room and hospitalizations for all causes. None of the ER visits or hospitalizations or deaths were related to this study.	0.00% 0/187 • Adverse events were collected from baseline to end of study participation for a total of approximately 9 months on all participants. This study tracked emergency room and hospitalizations for all causes. None of the ER visits or hospitalizations or deaths were related to this study.
Vascular disorders Hospitalization- left Carotid Artery Stent	0.53% 1/188 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 9 months on all participants. This study tracked emergency room and hospitalizations for all causes. None of the ER visits or hospitalizations or deaths were related to this study.	0.00% 0/187 • Adverse events were collected from baseline to end of study participation for a total of approximately 9 months on all participants. This study tracked emergency room and hospitalizations for all causes. None of the ER visits or hospitalizations or deaths were related to this study.
Surgical and medical procedures Hospitalization: Debridement of Metatarsal ulcer	0.53% 1/188 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 9 months on all participants. This study tracked emergency room and hospitalizations for all causes. None of the ER visits or hospitalizations or deaths were related to this study.	0.00% 0/187 • Adverse events were collected from baseline to end of study participation for a total of approximately 9 months on all participants. This study tracked emergency room and hospitalizations for all causes. None of the ER visits or hospitalizations or deaths were related to this study.
Respiratory, thoracic and mediastinal disorders Hospitalization: Endobronchial valve lung volume reduction sugery	0.53% 1/188 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 9 months on all participants. This study tracked emergency room and hospitalizations for all causes. None of the ER visits or hospitalizations or deaths were related to this study.	0.00% 0/187 • Adverse events were collected from baseline to end of study participation for a total of approximately 9 months on all participants. This study tracked emergency room and hospitalizations for all causes. None of the ER visits or hospitalizations or deaths were related to this study.
Gastrointestinal disorders Hospitalization: Obstruction Intestinal	0.53% 1/188 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 9 months on all participants. This study tracked emergency room and hospitalizations for all causes. None of the ER visits or hospitalizations or deaths were related to this study.	0.00% 0/187 • Adverse events were collected from baseline to end of study participation for a total of approximately 9 months on all participants. This study tracked emergency room and hospitalizations for all causes. None of the ER visits or hospitalizations or deaths were related to this study.
Reproductive system and breast disorders Hospitalization: Prostate Cancer	0.00% 0/188 • Adverse events were collected from baseline to end of study participation for a total of approximately 9 months on all participants. This study tracked emergency room and hospitalizations for all causes. None of the ER visits or hospitalizations or deaths were related to this study.	0.53% 1/187 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 9 months on all participants. This study tracked emergency room and hospitalizations for all causes. None of the ER visits or hospitalizations or deaths were related to this study.
Gastrointestinal disorders Hospitalization: Neoplasm of Rectum	0.00% 0/188 • Adverse events were collected from baseline to end of study participation for a total of approximately 9 months on all participants. This study tracked emergency room and hospitalizations for all causes. None of the ER visits or hospitalizations or deaths were related to this study.	0.53% 1/187 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 9 months on all participants. This study tracked emergency room and hospitalizations for all causes. None of the ER visits or hospitalizations or deaths were related to this study.
Nervous system disorders Hospitalization: Malignant Neoplasm Brain	0.00% 0/188 • Adverse events were collected from baseline to end of study participation for a total of approximately 9 months on all participants. This study tracked emergency room and hospitalizations for all causes. None of the ER visits or hospitalizations or deaths were related to this study.	0.53% 1/187 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 9 months on all participants. This study tracked emergency room and hospitalizations for all causes. None of the ER visits or hospitalizations or deaths were related to this study.
Gastrointestinal disorders Hospitalization: Acute Diarrhea	0.00% 0/188 • Adverse events were collected from baseline to end of study participation for a total of approximately 9 months on all participants. This study tracked emergency room and hospitalizations for all causes. None of the ER visits or hospitalizations or deaths were related to this study.	0.53% 1/187 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 9 months on all participants. This study tracked emergency room and hospitalizations for all causes. None of the ER visits or hospitalizations or deaths were related to this study.
Cardiac disorders Hospitalization: Pacemaker Cardiac Status Post	0.00% 0/188 • Adverse events were collected from baseline to end of study participation for a total of approximately 9 months on all participants. This study tracked emergency room and hospitalizations for all causes. None of the ER visits or hospitalizations or deaths were related to this study.	0.53% 1/187 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 9 months on all participants. This study tracked emergency room and hospitalizations for all causes. None of the ER visits or hospitalizations or deaths were related to this study.

Other adverse events

Adverse event data not reported

Additional Information

Roberto P. Benzo, MD

Mayo Clinic

Phone: 507-284-0561

Email: Benzo.Roberto@mayo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place