Chronic Bronchitis, COPD, Emphysema
Conditions
Keywords
Physical Activity, COPD Self-Management, Internet, 6-Minute Walk Test, COPD Exacerbation, Health-related Quality of Life
Brief summary
COPD currently afflicts 24 million US residents; the prevalence of COPD is high among Veterans. Persons with COPD have significant functional disability as a result of the disease. This project will determine whether a novel Internet-mediated walking program coupled with a pedometer can improve exercise capacity, improve health-related quality of life, and decrease the risk of acute exacerbations in persons with COPD. If successful, based on estimates that 33 to 64% of COPD patients are Internet users, the proposed exercise intervention could help over 8 million persons. The Veterans Health Administration (VHA) has a strong commitment to providing care to persons with COPD and supporting research directed at COPD-related disability. The 2012-2016 Strategic Plan of the VHA Office of Research and Development includes research in COPD rehabilitation. The proposed research addresses Rehabilitation R&D Service's current priority area of improving disabled Veterans' health-related quality of life by reducing disease burden and maximizing functional recovery.
Detailed description
Chronic obstructive pulmonary disease (COPD) is a major cause of global morbidity and is projected to become the third leading cause of death in the world by 2020. In Veterans, the prevalence is high; in VISN1 in FY 2012, 9% of outpatient Veterans had the ICD-9 diagnosis of COPD. In COPD, shortness of breath leads to physical inactivity and significant disability. A growing body of knowledge has identified physical activity and exercise as a modifiable factor that may impact COPD-related morbidity and mortality. Epidemiological and cross-sectional studies have shown that persons with COPD who are more physically active have better functional status and are less likely to be hospitalized and to die. A higher daily step count, when directly measured, is associated with lower risk of acute exacerbations (AEs) and mortality in COPD, independent of lung function. Despite the potential benefits, there have been few interventions to increase walking in persons with COPD. Although supervised pulmonary rehabilitation programs improve exercise capacity, they are not accessible to all who could benefit from them and have low adherence rates. Novel interventions that incorporate strategies for behavioral change and that are accessible, individualized, and sustained are needed to promote physical activity in persons limited by COPD. Funded by a RR&D CDA-2 Dr. Moy and her team have developed and piloted a novel exercise intervention that combines a website with a pedometer to promote walking in persons with COPD. The program, Every Step Counts (ESC) for Lung Health, accurately monitors walking, provides iterative feedback and individualized goal-setting, and delivers education and motivation. This study proposes a 2-arm randomized, controlled trial to study the efficacy of ESC to improve exercise capacity in persons with COPD, compared to usual care (verbal and written instructions to exercise). Primary Aim: Determine the efficacy of the ESC intervention to increase 6-minute walk test (6MWT) distance. Secondary Aims: Estimate the effect of the ESC intervention on (a) health-related quality of life (HRQL), as measured by the St. George's Respiratory Questionnaire (SGRQ), (b) dyspnea, (c) inflammatory biomarkers C-reactive protein (CRP) and interleukin-6 (IL-6), (d) risk for AEs and COPD-related hospitalizations, and (e) engagement in physical activity as measured by daily step count. 185 subjects will be enrolled for a total of 12 months, with the interventional phase being 6 months followed by an observational phase of 6 months. Subjects will be randomized (1:1 ratio) to one of 2 arms: (1) verbal and written instructions to exercise at home (usual care) or (2) usual care plus pedometer and Internet-mediated walking program. Subjects will perform 6MWTs, complete questionnaires, and have blood drawn at clinic visits at baseline, 3, 6, and 12 months. Telephone contact will occur at 9 months. AE history and daily step count will be assessed at each contact. Analysis of variance will compare 6MWT distance in the intervention and usual care group at 6 months. Multivariate regression models will assess 6MWT distance as a function of treatment group, adjusting for baseline 6MWT distance, study site, season of enrollment, and any unbalanced baseline characteristics. This study hypothesizes that persons randomized to ESC will have greater 6MWT distance at 6 months, compared to persons in the usual care group. It also hypothesize that persons randomized to ESC will have greater improvements in HRQL, dyspnea, daily step counts, and greater decreases in levels of inflammatory biomarker and risk for AEs and COPD-related hospitalizations, compared to control. The proposed intervention has the potential to (1) bring an exercise program to the vast majority of persons with COPD who cannot go to a hospital-based pulmonary rehabilitation program, (2) improve the effectiveness of current rehabilitation programs by sustaining long-term exercise, and (3) become an effective and integral part of COPD self-management programs. Ultimately, the intervention could decrease risk of hospitalizations, AEs, and COPD-related morbidity and mortality.
Interventions
Pedometer and website with feedback, goal setting, educational and motivational content, and community forum.
Sponsors
Study design
Masking description
Research assistant who assesses outcomes is blinded to randomization group.
Eligibility
Inclusion criteria
* Male and female subjects, greater than or equal to 40 years of age * Clinical diagnosis of COPD defined as either a ratio of FEV1 to forced vital capacity \< 0.70 or chest CT evidence of emphysema. CT obtained as part of routine clinical care, independent of research study. * Medical clearance from healthcare provider to participate in an exercise program * Have an active email account and can check email at least weekly * Have access to a computer with Internet connection or willing to come to VABoston or Birmingham VA Medical Center to use study computers * Pedometer with \>90% accuracy compared to manual counts on short clinic walk * Competent to provide informed consent * Willingness to make return visits and be available by telephone for duration of study
Exclusion criteria
* COPD exacerbation in the previous 1 month * Unable to ambulate with or without assistance * Clinical signs of unstable cardiovascular disease or congestive heart failure * Hypoxemia during 6MWT, i.e. oxygen saturation \<85% using supplemental oxygen * Unable to complete questionnaires * Unable to collect at least 5 of 7 days of baseline step counts * Participation in a pulmonary rehabilitation program at time of screening or within the previous 3 months * Participation in another exercise-related research study at time of screening * Plans to participate in an exercise-related research study in the next 6 months * Plans to enroll in a supervised exercise program, such as pulmonary rehabilitation, in the next 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 6-Minute Walk Test Distance | 6 months | In-clinic test that measures exercise capacity. Change in 6MWT distance at 6 months compared to baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health-related Quality of Life | 6 months | Questionnaires that assess quality of life. St. George's Respiratory Questionnaire Total Score Scores range 0-100 Higher score reflects worse HRQL. Change at 6 months compared to baseline |
| Dyspnea | 6 months | Assessed by questionnaire that measure breathlessness and shortness of breath. mMRC dyspnea score Scores range 0-4. Higher values reflect more shortness of breath. Change at 6 months compared to baseline |
| Engagement in Physical Activity | 6 months | Assessed by daily step counts on pedometer. Change at 6 months compared to baseline. |
| Inflammatory Biomarker Number 1 | 6 months | RAGE-receptor of advanced glycation end-products |
Other
| Measure | Time frame | Description |
|---|---|---|
| Inflammatory Biomarker Number 2 | 6 months | Inflammatory protein biomarker NT-proBNP (beta natriuretic peptide) |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled from Nov 2015-Nov 2019 at two US sites. VABoston (BOS) and VABirmingham (BIR). 204 consented (143 BOS and 61 BIR); 51 not randomized (38 ineligible and 13 withdrew); 153 randomized (108 BOS and 45 BIR); 75 allocated to Pedometer and Internet Website Arm (54 BOS and 21 BIR); 15 Lost to follow-up at 6 months (8 BOS and 7 BIR); 74 included in the analyses.
Pre-assignment details
51 not randomized (38 ineligible and 13 withdrew)
Participants by arm
| Arm | Count |
|---|---|
| Pedometer and Internet Website Pedometer and Website: Pedometer and website with feedback, goal setting, educational and motivational content, and community forum.
Participants were recruited from May 2015- February 2019 at two US sites. VABoston (BOS) and VABirmingham (BIR).
204 consented (143 BOS and 61 BIR) 51 not randomized (38 ineligible and 13 withdrew) 153 randomized (108 BOS and 45 BIR) 75 allocated to Pedometer and Internet Website Arm (54 BOS and 21 BIR) 15 Lost to follow-up at 6 months (8 BOS and 7 BIR) 74 included in the analyses | 75 |
| Usual Care Verbal instructions and written materials about exercise. Participants were recruited from May 2015- February 2019 at two US sites. VABoston (BOS) and VABirmingham (BIR).
204 consented (143 BOS and 61 BIR) 51 not randomized (38 ineligible and 13 withdrew) 153 randomized (108 BOS and 45 BIR) 78 allocated to Pedometer and Internet Website Arm (54 BOS and 24 BIR) 24 Lost to follow-up at 6 months (13 BOS and 11 BIR) 78 included in the analyses | 78 |
| Total | 153 |
Baseline characteristics
| Characteristic | Pedometer and Internet Website | Total | Usual Care |
|---|---|---|---|
| 6-Minute Walk Test Distance | 360.8 meters STANDARD_DEVIATION 92 | 359 meters STANDARD_DEVIATION 97.7 | 357.2 meters STANDARD_DEVIATION 103.5 |
| Age, Continuous | 69.2 years STANDARD_DEVIATION 7.2 | 69.3 years STANDARD_DEVIATION 7.3 | 70.4 years STANDARD_DEVIATION 7.3 |
| Daily Step Count | 3242 steps per day STANDARD_DEVIATION 2177 | 3281 steps per day STANDARD_DEVIATION 2222 | 3320 steps per day STANDARD_DEVIATION 2278 |
| FEV1 percent predicted | 60.6 percent STANDARD_DEVIATION 23.1 | 61.1 percent STANDARD_DEVIATION 21.4 | 61.5 percent STANDARD_DEVIATION 19.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 14 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 69 Participants | 138 Participants | 69 Participants |
| Sex: Female, Male Female | 5 Participants | 11 Participants | 6 Participants |
| Sex: Female, Male Male | 70 Participants | 142 Participants | 72 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 75 | 1 / 78 |
| other Total, other adverse events | 36 / 75 | 25 / 78 |
| serious Total, serious adverse events | 24 / 75 | 25 / 78 |
Outcome results
6-Minute Walk Test Distance
In-clinic test that measures exercise capacity. Change in 6MWT distance at 6 months compared to baseline.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pedometer and Internet Website | 6-Minute Walk Test Distance | 25 meters | Standard Error 10 |
| Usual Care | 6-Minute Walk Test Distance | 37 meters | Standard Error 10 |
Dyspnea
Assessed by questionnaire that measure breathlessness and shortness of breath. mMRC dyspnea score Scores range 0-4. Higher values reflect more shortness of breath. Change at 6 months compared to baseline
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pedometer and Internet Website | Dyspnea | -0.1 score on a scale | Standard Error 0.2 |
| Usual Care | Dyspnea | 0.0 score on a scale | Standard Error 0.2 |
Engagement in Physical Activity
Assessed by daily step counts on pedometer. Change at 6 months compared to baseline.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pedometer and Internet Website | Engagement in Physical Activity | 673 steps per day | Standard Error 392 |
| Usual Care | Engagement in Physical Activity | -639 steps per day | Standard Error 415 |
Health-related Quality of Life
Questionnaires that assess quality of life. St. George's Respiratory Questionnaire Total Score Scores range 0-100 Higher score reflects worse HRQL. Change at 6 months compared to baseline
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pedometer and Internet Website | Health-related Quality of Life | -13.0 score on a scale | Standard Error 3.6 |
| Usual Care | Health-related Quality of Life | -15.1 score on a scale | Standard Error 3.2 |
Inflammatory Biomarker Number 1
RAGE-receptor of advanced glycation end-products
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pedometer and Internet Website | Inflammatory Biomarker Number 1 | 95.0 pg/mL | Standard Deviation 319 |
| Usual Care | Inflammatory Biomarker Number 1 | 22.0 pg/mL | Standard Deviation 243 |
Inflammatory Biomarker Number 2
Inflammatory protein biomarker NT-proBNP (beta natriuretic peptide)
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pedometer and Internet Website | Inflammatory Biomarker Number 2 | 57.1 pg/mL | Standard Deviation 498 |
| Usual Care | Inflammatory Biomarker Number 2 | 69.2 pg/mL | Standard Deviation 314 |