Chronic Obstructive Pulmonary Disease (COPD), Emphysema
Conditions
Keywords
Pulmonary Rehabilitation
Brief 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.
Interventions
BEHAVIORALHome 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.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Randomization will be stratified by whether the participant has poor lung function (forced expiratory volume \[FEV1\] \<50% predicted) and whether the participant has severe dyspnea (recorded modified Medical Research Council Dyspnea Scale \[mMRC\] score, 3-4; scale, 0-4); critical factors that can make the study arms unbalanced regarding risk factors.
Eligibility
Sex/Gender
ALL
Age
40 Years to 99 Years
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Quality of Life | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Depression | 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. |
| Social Support | 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. |
| Change in Self-management Abilities | 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. |
| Change in Physical Activity | 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 . |
| Change in Daily Step Counts | Baseline, 3 months | Measured by the Actigraph wGT3X-BT worn for 7 days continuously to measure daily step count. |
| Change in Sleep Quality | 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. |
| Change in Anxiety | 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. |
| Healthcare Utilization | 3 months | Number of subjects to have an emergency room visits or hospitalization. |
| Meaning in Life | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 188 |
| Usual Care Subjects will receive 12 weeks of usual care. | 187 |
| Total | 375 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Became ineligible | 0 | 2 |
| Overall Study | Complicating disease | 0 | 1 |
| Overall Study | Death | 0 | 5 |
| Overall Study | Did not complete measures at 3-months | 17 | 14 |
| Overall Study | Disease progression | 3 | 0 |
| Overall Study | Lost to Follow-up | 2 | 1 |
| Overall Study | No baseline measures | 11 | 14 |
| Overall Study | Withdrawal by Subject | 12 | 8 |
Baseline characteristics
| Characteristic | Total | Pulmonary Rehabilitation Program Intervention | Usual Care |
|---|---|---|---|
| Age, Continuous | 69 years STANDARD_DEVIATION 9 | 69.335 years STANDARD_DEVIATION 9.53 | 68.676 years STANDARD_DEVIATION 9.53 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 2 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 362 Participants | 181 Participants | 181 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 10 Participants | 5 Participants | 5 Participants |
| Race/Ethnicity, Customized American Indian/Alaska Native | 2 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 2 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 8 Participants | 3 Participants | 5 Participants |
| Race/Ethnicity, Customized More than One Race | 5 Participants | 3 Participants | 2 Participants |
| Race/Ethnicity, Customized Native Hawaiian/Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 357 Participants | 177 Participants | 180 Participants |
| Region of Enrollment United States | 375 participants | 188 participants | 187 participants |
| Sex: Female, Male Female | 212 Participants | 101 Participants | 111 Participants |
| Sex: Female, Male Male | 163 Participants | 87 Participants | 76 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 188 | 5 / 187 |
| other Total, other adverse events | 0 / 188 | 0 / 187 |
| serious Total, serious adverse events | 15 / 188 | 15 / 187 |
Outcome results
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Pulmonary Rehabilitation Program Intervention | Change in Quality of Life | CRQ Physical | 0.37 score on a scale |
| Pulmonary Rehabilitation Program Intervention | Change in Quality of Life | CRQ Emotional | 0.43 score on a scale |
| Usual Care | Change in Quality of Life | CRQ Physical | -0.17 score on a scale |
| Usual Care | Change in Quality of Life | CRQ Emotional | -0.08 score on a scale |
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Pulmonary Rehabilitation Program Intervention | Change in Anxiety | -0.42 score on a scale |
| Usual Care | Change in Anxiety | -0.24 score on a scale |
p-value: 0.1548t-test, 2 sided
Secondary
Change in Daily Step Counts
Measured by the Actigraph wGT3X-BT worn for 7 days continuously to measure daily step count.
Time frame: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Pulmonary Rehabilitation Program Intervention | Change in Daily Step Counts | 478.63 steps/day |
| Usual Care | Change in Daily Step Counts | -146.53 steps/day |
p-value: 0.0113t-test, 2 sided
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Pulmonary Rehabilitation Program Intervention | Change in Depression | -1.12 score on a scale |
| Usual Care | Change in Depression | 0.08 score on a scale |
p-value: 0.0021t-test, 2 sided
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 .
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Pulmonary Rehabilitation Program Intervention | Change in Physical Activity | Daily Light Physical Activity | 17.51 minutes |
| Pulmonary Rehabilitation Program Intervention | Change in Physical Activity | Daily Moderate Physical Activity | 4.47 minutes |
| Usual Care | Change in Physical Activity | Daily Light Physical Activity | 0.6 minutes |
| Usual Care | Change in Physical Activity | Daily Moderate Physical Activity | -4.82 minutes |
Comparison: Daily Light Physical Activityp-value: 0.0788t-test, 2 sided
Comparison: Daily Moderate Physical Activityp-value: 0.0742t-test, 2 sided
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Pulmonary Rehabilitation Program Intervention | Change in Self-management Abilities | 3.84 score on a scale |
| Usual Care | Change in Self-management Abilities | 0.54 score on a scale |
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Pulmonary Rehabilitation Program Intervention | Change in Sleep Quality | -0.72 score on a scale |
| Usual Care | Change in Sleep Quality | 0.03 score on a scale |
p-value: 0.0068t-test, 2 sided
Secondary
Healthcare Utilization
Number of subjects to have an emergency room visits or hospitalization.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pulmonary Rehabilitation Program Intervention | Healthcare Utilization | Any Hospitalization | 15 Participants |
| Pulmonary Rehabilitation Program Intervention | Healthcare Utilization | Any Emergency Room Visit | 13 Participants |
| Usual Care | Healthcare Utilization | Any Emergency Room Visit | 24 Participants |
| Usual Care | Healthcare Utilization | Any Hospitalization | 15 Participants |
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Pulmonary Rehabilitation Program Intervention | Meaning in Life | 0.07 score on a scale |
| Usual Care | Meaning in Life | -0.33 score on a scale |
p-value: 0.4762t-test, 2 sided
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Pulmonary Rehabilitation Program Intervention | Social Support | 0.58 score on a scale |
| Usual Care | Social Support | -0.04 score on a scale |
p-value: 0.2216t-test, 2 sided