Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| I01RX002855 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Persons with COPD have significant functional disability but cannot access rehabilitative treatment at hospital-based conventional pulmonary rehabilitation (PR) programs. This project will determine whether an Internet-mediated, pedometer-based walking program can increase physical activity in persons with COPD who qualify for but cannot access PR, compared to usual care. This proposal has high potential to deliver an immediate solution to a pressing clinical need. 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.
Conventional pulmonary rehabilitation (PR) programs are highly effective and the standard of care in patients with chronic obstructive pulmonary disease (COPD). PR faces two significant problems: (1) most patients with COPD who would benefit from PR cannot access it, and 2) there is no effective long-term strategy to maintain physical activity (PA) and benefits after completing PR. The investigators propose a randomized controlled trial (RCT) to test the efficacy of a technology-mediated intervention to increase PA in persons with COPD who qualify for but cannot access conventional, hospital-based PR. COPD is a leading cause of death in the United States; an estimated 16 million Americans have COPD. Despite maximal medical therapy, patients with COPD characteristically experience breathlessness, which leads to a downward spiral of sedentary behavior, physical inactivity, deconditioning, and functional disability. Low physical activity is associated with poor outcomes in COPD--increased risk of acute exacerbations, hospitalizations, and death, independent of lung function. The Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines recommend regular PA for all patients with COPD. Conventional, supervised PR programs clearly reduce breathlessness, and improve health-related quality of life (HRQL) and exercise capacity. However, PR programs face significant challenges of access and adherence. The investigators developed Every Step Counts (ESC), a technology-mediated intervention based on the Behavioral Theory of Self-Regulation, to target sedentary behavior, promote PA, and alleviate deconditioning. ESC couples a website with a pedometer to directly monitor step counts. The website provides individualized step-count goals, iterative feedback, education on disease self-management, motivation, and an online community of social support. In two randomized studies in Veterans with COPD, the investigators demonstrated ESC's safety, feasibility, and efficacy to increase PA. Accessible via the internet and available at any time from home, ESC could be an ideal low-cost platform to address the limitations of conventional PR. The investigators hypothesize that ESC may be an efficacious strategy to promote PA in the many patients who cannot attend a PR program.
Primary Aim 1: Determine the efficacy of a web-based intervention, ESC, to increase PA (measured directly with an accelerometer and a questionnaire that assesses intensity), compared to usual care, in persons with COPD who are referred to or eligible for conventional PR but who cannot access it.
Secondary Aim 2: Estimate the effect of the ESC intervention on (a) exercise self-efficacy, (b) HRQL, (c) dyspnea, (d) depression, and (e) risk of acute exacerbations and COPD-related hospitalizations, compared to usual care.
All study visits are performed either in-person or remotely starting September, 2021.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | No Intervention | Patients referred to conventional PR or eligible for PR but declined or cannot access. Using a standardized script at the randomization phone call, study staff will deliver verbal instructions to slowly and steadily increase one's walking and exercise each week. Participants will be asked to perform exercise of moderate intensity for at least 30 minutes on most days of the week, defined as a dyspnea level of 4-5 on the Borg scale and taking 1-2 minutes to recover. Use of the Borg rating scale for dyspnea will be reviewed with each participant. Exercise is defined as planned PA, outside of activities performed as part of one's daily routine. Exercise can be walking in the community or using exercise equipment at a local gym. Adapted written materials reinforce the verbal instructions. Participants will receive this 45-page spiral-bound book with information about aerobic and strength training exercises. | |
| Every Step Counts Intervention | Experimental | Patients referred to conventional PR or eligible for PR but declined or cannot access. After randomization to ESC, participants will be mailed detailed instructions about the website. They will be asked to wear the lightweight, unobtrusive pedometer every day, except while asleep or showering/bathing, during the 12-week intervention period. Subjects will be instructed to upload their date and time-stamped step-count data to the study website at least weekly. Each week, the study computer will run the goal calculation algorithm and provide each participant with his/her daily step-count goal for the week. The week's step-count goal will be displayed on each subject's personal study web page. Participants will be instructed to exercise and reach their individualized step-count goals with walking of moderate intensity for at least 30 minutes on most days of the week, defined as a dyspnea level of 4-5 on the Borg scale and taking 1-2 minutes to recover. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Every Step Counts | Other | Pedometer coupled to a website that provides step-count goals, feedback, education, motivation, and social support. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Physical Activity Measured as Change in Average Daily Step Count | Daily Step Count was directly measured with a wearable monitoring device. Change in daily step count at 12 weeks compared to baseline from the adjusted mixed model. | 12 weeks compared to baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Exercise Self-Regulatory Efficacy Measured as Change Score | Assessed by the Exercise Self-Regulatory Efficacy Scale questionnaire. 16-item questionnaire. Participants indicate their confidence level from 0% (not at all confident) to 100% (highly confident). Change in EX-SRES score at 12 weeks compared to baseline from the adjusted mixed model. | 12 weeks compared to baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Health Utilities Measured as Change Score | EuroQoL 5-Dimension Health Questionnaire (EQ-5D) Health Utilities. The responses to the five EQ-5D dimensions (i.e. an EQ-5D health state or profile) can be converted into a single number called an index value. The index value reflects how good or bad the health state is according to the preferences of the general population of the United States. Scale ranges from -0.573 to 1 for the United States, with -0.573 indicating the worst health state and 1 indicating the best health state. Change in score at 12 weeks compared to baseline from the adjusted mixed model. |
Inclusion Criteria are:
Exclusion Criteria are:
COPD exacerbation in the previous 1 month
Prescribed supplemental oxygen for activity+
Inability to ambulate with or without assistance
Use of assistive device for walking such as cane or walker*
Inability to complete questionnaires
Inability to collect at least 7 of 10 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 3 months
Average baseline step counts of greater than or equal to 10,000 steps per week
For those who wish to participate virtually.
If participant has an in-person visit, oxygen will be assessed during the 6MWT to determine if subject's oxygen is stable during activity. If a participant has an in-person visit and oxygen is documented during the 6MWT and stays above 85%, he/she will be eligible to participate.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Marilyn L. Moy, MD | VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA | Boston | Massachusetts | 02130-4817 | United States |
Datasets meeting VA standards for disclosure to the public will be made available within 1 year of publication.
The PI will create de-identified, study-specific datasets. Investigators requesting a copy of a dataset will sign a Letter of Agreement or a Data Use Agreement. A local privacy officer will certify that a dataset contains no PHI, PII, or VA Sensitive Information prior to release outside VA.
Not provided
Not provided
Not provided
Not provided
37 not randomized (28 ineligible, 5 lost to follow-up, 4 withdrew)
Participants were enrolled from September, 2019-June, 2024 at VA Boston.
146 consented; 109 randomized (57 allocated to intervention, 52 allocated to usual care); 109 included in final analysis and analyzed as intention-to-treat
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Every Step Counts Intervention | Patients referred to conventional PR or eligible for PR but declined or cannot access were enrolled. After randomization to ESC, participants will be mailed detailed instructions about the website. They will be asked to wear the lightweight, unobtrusive pedometer every day, except while asleep or showering/bathing, during the 12-week intervention period. Subjects will be instructed to upload their date and time-stamped step-count data to the study website at least weekly. Each week, the study computer will run the goal calculation algorithm and provide each participant with his/her daily step-count goal for the week. The week's step-count goal will be displayed on each subject's personal study web page. Participants will be instructed to exercise and reach their individualized step-count goals with walking of moderate intensity for at least 30 minutes on most days of the week, defined as a dyspnea level of 4-5 on the Borg scale and taking 1-2 minutes to recover. |
| FG001 | Usual Care | Patients referred to conventional PR or eligible for PR but declined or cannot access were enrolled. Using a standardized script at the randomization phone call, study staff will deliver verbal instructions to slowly and steadily increase one's walking and exercise each week. Participants will be asked to perform exercise of moderate intensity for at least 30 minutes on most days of the week, defined as a dyspnea level of 4-5 on the Borg scale and taking 1-2 minutes to recover. Use of the Borg rating scale for dyspnea will be reviewed with each participant. Exercise is defined as planned PA, outside of activities performed as part of one's daily routine. Exercise can be walking in the community or using exercise equipment at a local gym. Adapted written materials reinforce the verbal instructions. Participants will receive this 45-page spiral-bound book with information about aerobic and strength training exercises. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
No randomized participants were excluded from analyses at baseline
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Every Step Counts Intervention | Patients referred to conventional PR or eligible for PR but declined or cannot access were enrolled. After randomization to ESC, participants will be mailed detailed instructions about the website. They will be asked to wear the lightweight, unobtrusive pedometer every day, except while asleep or showering/bathing, during the 12-week intervention period. Subjects will be instructed to upload their date and time-stamped step-count data to the study website at least weekly. Each week, the study computer will run the goal calculation algorithm and provide each participant with his/her daily step-count goal for the week. The week's step-count goal will be displayed on each subject's personal study web page. Participants will be instructed to exercise and reach their individualized step-count goals with walking of moderate intensity for at least 30 minutes on most days of the week, defined as a dyspnea level of 4-5 on the Borg scale and taking 1-2 minutes to recover. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Age > 40 years |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Physical Activity Measured as Change in Average Daily Step Count | Daily Step Count was directly measured with a wearable monitoring device. Change in daily step count at 12 weeks compared to baseline from the adjusted mixed model. | Posted | Mean | Standard Error | steps per day | 12 weeks compared to baseline |
|
Each participant was followed from enrollment until the end of the intervention, up to 12 weeks, for adverse events.
Adverse events were monitored and assessed at follow-up study visits. We didn't specifically ask by organ system, but classified by organ systems after we received participant reports.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Every Step Counts Intervention | Patients referred to conventional PR or eligible for PR but declined or cannot access were enrolled. After randomization to ESC, participants will be mailed detailed instructions about the website. They will be asked to wear the lightweight, unobtrusive pedometer every day, except while asleep or showering/bathing, during the 12-week intervention period. Subjects will be instructed to upload their date and time-stamped step-count data to the study website at least weekly. Each week, the study computer will run the goal calculation algorithm and provide each participant with his/her daily step-count goal for the week. The week's step-count goal will be displayed on each subject's personal study web page. Participants will be instructed to exercise and reach their individualized step-count goals with walking of moderate intensity for at least 30 minutes on most days of the week, defined as a dyspnea level of 4-5 on the Borg scale and taking 1-2 minutes to recover. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Respiratory | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Musculoskeletal | Musculoskeletal and connective tissue disorders | Systematic Assessment |
First, changes such as how visits were conducted were made to the study protocol after the trial was underway due to the COVID-19 pandemic. Second, walking intensity was not objectively measured. Third, the lack of racial and ethnic diversity and paucity of women limits generalizability of results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marilyn Moy, MD | VA Boston Healthcare System | 857-203-6622 | marilyn.moy@va.gov |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 20, 2023 | Jan 30, 2026 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
Not provided
Not provided
As the primary aim, the investigators propose a RCT to study the efficacy of a web-based, pedometer-mediated physical activity intervention to increase physical activity in persons with COPD who would benefit from but cannot access conventional pulmonary rehabilitation, compared to usual care. The investigators anticipate that 120 subjects will be randomized 1:1 to either the intervention or usual care.
Not provided
Not provided
Study staff communicating randomization assignments to subjects will be different from study staff conducting follow-up outcome assessments.
| Disease Specific Health-Related Quality of Life Measured as Change Score | Assessed by the St. George's Respiratory Questionnaire. The investigators will use the Total Score which ranges from 0 to 100, with lower scores representing better health related quality of life. Change in total score at 12 weeks compared to baseline from the adjusted mixed model. | 12 weeks compared to baseline |
| Shortness of Breath Rating as Perceived by the Participant Measured as Change Score | The modified Medical Research Council (mMRC) dyspnea scale ranges from 0 to 4, with higher numbers representing more shortness of breath. Change at 12 weeks compared to baseline from the adjusted mixed model. | 12 weeks compared to baseline |
| Depression Self-reported on Questionnaire Measured as Change Score | Depression measured by the Beck's Depression Inventory-II questionnaire. 21-items. Scores range with 0 to 63 with higher scores representing greater severity of depression. Change in score at 12 weeks compared to baseline from the adjusted mixed model. | 12 weeks compared to baseline |
| CHAMPS Physical Activity Questionnaire Measured as Change Score | Self-reported PA will be assessed with The Community Healthy Activities Model Program for Seniors (CHAMPS) Physical Activity questionnaire, a 41-item measure of the frequency and duration of PA over a typical week over the past four weeks that is used to calculate estimated caloric expenditure per week. Change in score at 12 weeks compared to baseline from the adjusted mixed model. | 12 weeks compared to baseline |
| Rapid Assessment of Physical Activity (RAPA) Questionnaire | Self-reported physical activity intensity was measured with the 7-item Rapid Assessment of PA (RAPA) questionnaire. Levels placed into three categories based on the highest physical activity level affirmatively endorsed: sedentary (score=1), underactive (score=2-5), and active (score >6) at 12 weeks compared to baseline. | 12 weeks compared to baseline |
| Healthcare Utilization Represented by Number of Hospitalizations Over Timeframe | Hospitalization History. Assessment of total number of all cause hospitalizations over the timeframe of 12 weeks based on self-report. | 12 weeks |
| Healthcare Utilization Represented by Number of Acute Exacerbations Over Timeframe | Acute Exacerbation History. Assessment of total number of acute exacerbations (AEs) over the timeframe of 12 weeks based on self-report. | 12 weeks |
| 12 weeks compared to baseline |
| Number of Participants Who Plan to Enroll in Conventional Pulmonary Rehabilitation After Participating in the Research Study | Numbers were assessed by self-report. | 12 weeks |
| COPD Knowledge Measured as Change Score | Bristol COPD Knowledge Questionnaire was used. 13-items that usually takes between 10 and 20 minutes to complete. Percent of questions scored correctly is assessed and range from 0 to 100 %. Change in score at 12 weeks compared to baseline from the adjusted mixed model. | 12 weeks compared to baseline |
| Sleepiness Measured as Change Score | Epworth Sleepiness Scale was used. 8 questions, each on a scale of 0-3. Minimum score is 0 and maximum score is 24. 0-5 Lower Normal Daytime Sleepiness 6-10 Higher Normal Daytime Sleepiness 11-12 Mild Excessive Daytime Sleepiness 13-15 Moderate Excessive Daytime Sleepiness 16-24 Severe Excessive Daytime Sleepiness. Change in score at 12 weeks compared to baseline from the adjusted mixed model. | 12 weeks compared to baseline |
| Social Support Measured as Change Score | MOS Social Support Survey was used. 18 items with scores ranging from 0 to 100, with higher scores representing greater social support. Change in score at 12 weeks compared to baseline from the adjusted mixed model. | 12 weeks compared to baseline |
| General Health-Related Quality of Life Measured as Change Score | The Veterans RAND-36 is a 36-item self-report measure of general HRQL in U.S. Veterans based on the original RAND SF-36. Items assess participants' perception of their physical and mental health. Physical health (PCS) and mental health (MCS) component scores will be calculated as t scores normed to the general U.S. Veteran population with a mean score of 50 and a standard deviation of 10, with higher scores indicating better health outcomes. Change score at 12 weeks compared to baseline from the adjusted mixed model. | 12 weeks compared to baseline |
| Change in 6-Minute Walk Test Distance | In-clinic test that measures exercise capacity. Change in 6MWT distance at 12 weeks compared to baseline from the adjusted mixed model. | 12 weeks compared to baseline |
| Death |
|
| Withdrawal by Subject |
|
| BG001 | Usual Care | Patients referred to conventional PR or eligible for PR but declined or cannot access were enrolled. Using a standardized script at the randomization phone call, study staff will deliver verbal instructions to slowly and steadily increase one's walking and exercise each week. Participants will be asked to perform exercise of moderate intensity for at least 30 minutes on most days of the week, defined as a dyspnea level of 4-5 on the Borg scale and taking 1-2 minutes to recover. Use of the Borg rating scale for dyspnea will be reviewed with each participant. Exercise is defined as planned PA, outside of activities performed as part of one's daily routine. Exercise can be walking in the community or using exercise equipment at a local gym. Adapted written materials reinforce the verbal instructions. Participants will receive this 45-page spiral-bound book with information about aerobic and strength training exercises. |
| BG002 | Total | Total of all reporting groups |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Number of participants male/female by group | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Daily Step Count Average | Daily Step Count was directly measured with a wearable monitoring device. At baseline, daily step counts were averaged over >7 wear days. | Mean | Standard Deviation | steps per day |
|
| FEV1 Percent Predicted | FEV1 percent predicted was obtained either from in-person spirometry or extracted from the medical chart. | Mean | Standard Deviation | percent predicted of FEV1 |
|
| OG001 | Usual Care | Patients referred to conventional PR or eligible for PR but declined or cannot access. Using a standardized script at the randomization phone call, study staff will deliver verbal instructions to slowly and steadily increase one's walking and exercise each week. Participants will be asked to perform exercise of moderate intensity for at least 30 minutes on most days of the week, defined as a dyspnea level of 4-5 on the Borg scale and taking 1-2 minutes to recover. Use of the Borg rating scale for dyspnea will be reviewed with each participant. Exercise is defined as planned PA, outside of activities performed as part of one's daily routine. Exercise can be walking in the community or using exercise equipment at a local gym. Adapted written materials reinforce the verbal instructions. Participants will receive this 45-page spiral-bound book with information about aerobic and strength training exercises. |
|
|
|
| Secondary | Exercise Self-Regulatory Efficacy Measured as Change Score | Assessed by the Exercise Self-Regulatory Efficacy Scale questionnaire. 16-item questionnaire. Participants indicate their confidence level from 0% (not at all confident) to 100% (highly confident). Change in EX-SRES score at 12 weeks compared to baseline from the adjusted mixed model. | Posted | Mean | Standard Error | score on a scale | 12 weeks compared to baseline |
|
|
|
|
| Secondary | Disease Specific Health-Related Quality of Life Measured as Change Score | Assessed by the St. George's Respiratory Questionnaire. The investigators will use the Total Score which ranges from 0 to 100, with lower scores representing better health related quality of life. Change in total score at 12 weeks compared to baseline from the adjusted mixed model. | Posted | Mean | Standard Error | score on a scale | 12 weeks compared to baseline |
|
|
|
|
| Secondary | Shortness of Breath Rating as Perceived by the Participant Measured as Change Score | The modified Medical Research Council (mMRC) dyspnea scale ranges from 0 to 4, with higher numbers representing more shortness of breath. Change at 12 weeks compared to baseline from the adjusted mixed model. | Posted | Mean | Standard Error | score on a scale | 12 weeks compared to baseline |
|
|
|
|
| Secondary | Depression Self-reported on Questionnaire Measured as Change Score | Depression measured by the Beck's Depression Inventory-II questionnaire. 21-items. Scores range with 0 to 63 with higher scores representing greater severity of depression. Change in score at 12 weeks compared to baseline from the adjusted mixed model. | Posted | Mean | Standard Error | score on a scale | 12 weeks compared to baseline |
|
|
|
|
| Secondary | CHAMPS Physical Activity Questionnaire Measured as Change Score | Self-reported PA will be assessed with The Community Healthy Activities Model Program for Seniors (CHAMPS) Physical Activity questionnaire, a 41-item measure of the frequency and duration of PA over a typical week over the past four weeks that is used to calculate estimated caloric expenditure per week. Change in score at 12 weeks compared to baseline from the adjusted mixed model. | Posted | Mean | Standard Error | caloric expenditure per week | 12 weeks compared to baseline |
|
|
|
|
| Other Pre-specified | Health Utilities Measured as Change Score | EuroQoL 5-Dimension Health Questionnaire (EQ-5D) Health Utilities. The responses to the five EQ-5D dimensions (i.e. an EQ-5D health state or profile) can be converted into a single number called an index value. The index value reflects how good or bad the health state is according to the preferences of the general population of the United States. Scale ranges from -0.573 to 1 for the United States, with -0.573 indicating the worst health state and 1 indicating the best health state. Change in score at 12 weeks compared to baseline from the adjusted mixed model. | Posted | Mean | Standard Error | score on a scale | 12 weeks compared to baseline |
|
|
|
|
| Other Pre-specified | Number of Participants Who Plan to Enroll in Conventional Pulmonary Rehabilitation After Participating in the Research Study | Numbers were assessed by self-report. | 13 participants were lost to follow-up at 12 weeks | Posted | Count of Participants | Participants | 12 weeks |
|
|
|
|
| Other Pre-specified | COPD Knowledge Measured as Change Score | Bristol COPD Knowledge Questionnaire was used. 13-items that usually takes between 10 and 20 minutes to complete. Percent of questions scored correctly is assessed and range from 0 to 100 %. Change in score at 12 weeks compared to baseline from the adjusted mixed model. | Posted | Mean | Standard Error | score on a scale | 12 weeks compared to baseline |
|
|
|
|
| Other Pre-specified | Sleepiness Measured as Change Score | Epworth Sleepiness Scale was used. 8 questions, each on a scale of 0-3. Minimum score is 0 and maximum score is 24. 0-5 Lower Normal Daytime Sleepiness 6-10 Higher Normal Daytime Sleepiness 11-12 Mild Excessive Daytime Sleepiness 13-15 Moderate Excessive Daytime Sleepiness 16-24 Severe Excessive Daytime Sleepiness. Change in score at 12 weeks compared to baseline from the adjusted mixed model. | Score | Posted | Mean | Standard Error | score on a scale | 12 weeks compared to baseline |
|
|
|
|
| Other Pre-specified | Social Support Measured as Change Score | MOS Social Support Survey was used. 18 items with scores ranging from 0 to 100, with higher scores representing greater social support. Change in score at 12 weeks compared to baseline from the adjusted mixed model. | Posted | Mean | Standard Error | score on a scale | 12 weeks compared to baseline |
|
|
|
|
| Other Pre-specified | General Health-Related Quality of Life Measured as Change Score | The Veterans RAND-36 is a 36-item self-report measure of general HRQL in U.S. Veterans based on the original RAND SF-36. Items assess participants' perception of their physical and mental health. Physical health (PCS) and mental health (MCS) component scores will be calculated as t scores normed to the general U.S. Veteran population with a mean score of 50 and a standard deviation of 10, with higher scores indicating better health outcomes. Change score at 12 weeks compared to baseline from the adjusted mixed model. | Posted | Mean | Standard Error | t-score | 12 weeks compared to baseline |
|
|
|
|
| Secondary | Rapid Assessment of Physical Activity (RAPA) Questionnaire | Self-reported physical activity intensity was measured with the 7-item Rapid Assessment of PA (RAPA) questionnaire. Levels placed into three categories based on the highest physical activity level affirmatively endorsed: sedentary (score=1), underactive (score=2-5), and active (score >6) at 12 weeks compared to baseline. | Difference in number of participants here is due to missing/incomplete data at baseline or 12 week visit | Posted | Count of Participants | Participants | 12 weeks compared to baseline |
|
|
|
|
| Secondary | Healthcare Utilization Represented by Number of Hospitalizations Over Timeframe | Hospitalization History. Assessment of total number of all cause hospitalizations over the timeframe of 12 weeks based on self-report. | Difference in number of participants analyzed compared to overall analysis is due to drop-outs after baseline and after 12 weeks. | Posted | Number | count of events | 12 weeks |
|
|
|
| Other Pre-specified | Change in 6-Minute Walk Test Distance | In-clinic test that measures exercise capacity. Change in 6MWT distance at 12 weeks compared to baseline from the adjusted mixed model. | Only participants who participated in the study in-person performed the 6MWT. | Posted | Mean | Standard Error | meters | 12 weeks compared to baseline |
|
|
|
|
| Secondary | Healthcare Utilization Represented by Number of Acute Exacerbations Over Timeframe | Acute Exacerbation History. Assessment of total number of acute exacerbations (AEs) over the timeframe of 12 weeks based on self-report. | Difference in number of participants analyzed compared to overall analysis is due to drop-outs after baseline and after 12 weeks. | Posted | Number | count of acute exacerbations | 12 weeks |
|
|
|
| 0 |
| 57 |
| 7 |
| 57 |
| 38 |
| 57 |
| EG001 | Usual Care | Patients referred to conventional PR or eligible for PR but declined or cannot access were enrolled. Using a standardized script at the randomization phone call, study staff will deliver verbal instructions to slowly and steadily increase one's walking and exercise each week. Participants will be asked to perform exercise of moderate intensity for at least 30 minutes on most days of the week, defined as a dyspnea level of 4-5 on the Borg scale and taking 1-2 minutes to recover. Use of the Borg rating scale for dyspnea will be reviewed with each participant. Exercise is defined as planned PA, outside of activities performed as part of one's daily routine. Exercise can be walking in the community or using exercise equipment at a local gym. Adapted written materials reinforce the verbal instructions. Participants will receive this 45-page spiral-bound book with information about aerobic and strength training exercises. | 1 | 52 | 3 | 52 | 21 | 52 |
| Musculoskeletal | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Cardiac | Cardiac disorders | Systematic Assessment |
|
| Renal | Renal and urinary disorders | Systematic Assessment |
|
| Blood | Blood and lymphatic system disorders | Systematic Assessment |
|
| Chest | Cardiac disorders | Systematic Assessment |
|
| Respiratory | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Ear | Ear and labyrinth disorders | Systematic Assessment |
|
| Gastrointestinal | Gastrointestinal disorders | Systematic Assessment |
|
| General | General disorders | Systematic Assessment |
|
| Infections | Infections and infestations | Systematic Assessment |
|
| Injury | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Nervous system | Nervous system disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
| 0.739 |
| Mean Difference (Final Values) |
| 0.96 |
| Superiority |
weekly caloric expenditure (moderate intensity activities); Generalized linear mixed-effects models (PROC MIXED, SAS v9.4), adjusting for FEV1 %predicted, season, and study mode, assessed between-group change.
| Mixed Models Analysis |
| 0.276 |
| Mean Difference (Final Values) |
| 606.33 |
| Superiority |
| Mixed Models Analysis |
| 0.653 |
For Mental Component Score |
| Mean Difference (Final Values) |
| 0.96 |
| Superiority |
| Baseline active - 12 week under-active |
|
| Baseline under-active - 12 week under-active |
|
| 0.763 |
| McNemar statistic |
| 0.09 |
| Superiority |