COPDWEBNCT02099799
The Effect of Physical Activity Promotion on Short and Long-term Outcomes in COPD
A study testing Pedometer and Website in people with COPD and Emphysema, run by VA Office of Research and Development at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD, Emphysema, Chronic Bronchitis
- What is being tested?
- Pedometer and Website
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 Nov 2015to 7 Feb 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Birmingham VA Medical Center, Birmingham, AL
Birmingham, Alabama, 35233
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, 02130
About this study
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.
Read the 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.
- Conditions
- COPD, Emphysema, Chronic Bronchitis
- Being tested
- Pedometer and Website
- Keywords
- Physical Activity, COPD Self-Management, Internet, 6-Minute Walk Test, COPD Exacerbation, Health-related Quality of Life
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Emphysema, Bronchitis, Chronic, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pedometer and WebsiteBehavioural
Pedometer and website with feedback, goal setting, educational and motivational content, and community forum.
| Study group | Role | What they receive |
|---|---|---|
| Pedometer and Internet Website | Active comparator | Pedometer and website with feedback, goal setting, educational and motivational content, and community forum. Receives: Behavioral: Pedometer and Website |
| Usual Care | No intervention | Verbal instructions and written materials about exercise. |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-Minute Walk Test Distance
In-clinic test that measures exercise capacity. Change in 6MWT distance at 6 months compared to baseline.
Measured: 6 months
Secondary outcomes (4)
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
Measured: 6 months
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
Measured: 6 months
Engagement in Physical Activity
Assessed by daily step counts on pedometer.
Change at 6 months compared to baseline.
Measured: 6 months
Inflammatory Biomarker Number 1
RAGE-receptor of advanced glycation end-products
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2014 (estimated)
- Study start17 Nov 2015
- Primary completion1 Nov 2019
- Study completion7 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Marilyn L. Moy, MD, Principal investigator, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02099799
- Sponsor's protocol ID
- O1150-R
- Acronym
- WEB
- Status last verified
- Aug 2021
- First submitted
- 20 Mar 2014
- Last updated
- 5 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Moy ML, Matthess K, Stolzmann K, Reilly J, Garshick E. Free-living physical activity in COPD: assessment with accelerometer and activity checklist. J Rehabil Res Dev. 2009;46(2):277-86. doi: 10.1682/jrrd.2008.07.0083.
PubMed 19533541Moy ML, Janney AW, Nguyen HQ, Matthess KR, Cohen M, Garshick E, Richardson CR. Use of pedometer and Internet-mediated walking program in patients with chronic obstructive pulmonary disease. J Rehabil Res Dev. 2010;47(5):485-96. doi: 10.1682/jrrd.2009.07.0091.
PubMed 20803392Moy ML, Teylan M, Danilack VA, Gagnon DR, Garshick E. An index of daily step count and systemic inflammation predicts clinical outcomes in chronic obstructive pulmonary disease. Ann Am Thorac Soc. 2014 Feb;11(2):149-57. doi: 10.1513/AnnalsATS.201307-243OC.
PubMed 24308588Danilack VA, Weston NA, Richardson CR, Mori DL, Moy ML. Reasons persons with COPD do not walk and relationship with daily step count. COPD. 2014 Jun;11(3):290-9. doi: 10.3109/15412555.2013.841670. Epub 2013 Oct 23.
PubMed 24152213Moy ML, Teylan M, Weston NA, Gagnon DR, Danilack VA, Garshick E. Daily step count is associated with plasma C-reactive protein and IL-6 in a US cohort with COPD. Chest. 2014 Mar 1;145(3):542-550. doi: 10.1378/chest.13-1052.
PubMed 24091482Moy ML, Teylan M, Weston NA, Gagnon DR, Garshick E. Daily step count predicts acute exacerbations in a US cohort with COPD. PLoS One. 2013 Apr 4;8(4):e60400. doi: 10.1371/journal.pone.0060400. Print 2013.
PubMed 23593211Moy ML, Danilack VA, Weston NA, Garshick E. Daily step counts in a US cohort with COPD. Respir Med. 2012 Jul;106(7):962-9. doi: 10.1016/j.rmed.2012.03.016. Epub 2012 Apr 20.
PubMed 22521225Moy ML, Garshick E, Matthess KR, Lew R, Reilly JJ. Accuracy of uniaxial accelerometer in chronic obstructive pulmonary disease. J Rehabil Res Dev. 2008;45(4):611-7. doi: 10.1682/jrrd.2007.09.0147.
PubMed 18712646Moy ML, Collins RJ, Martinez CH, Kadri R, Roman P, Holleman RG, Kim HM, Nguyen HQ, Cohen MD, Goodrich DE, Giardino ND, Richardson CR. An Internet-Mediated Pedometer-Based Program Improves Health-Related Quality-of-Life Domains and Daily Step Counts in COPD: A Randomized Controlled Trial. Chest. 2015 Jul;148(1):128-137. doi: 10.1378/chest.14-1466.
PubMed 25811395Berube MN, Robinson SA, Wan ES, Mongiardo MA, Finer EB, Moy ML. Physical Activity and Systemic Biomarkers in Persons With COPD: Insights from a Web-Based Pedometer-Mediated Intervention. Chronic Obstr Pulm Dis. 2024 Jul 25;11(4):369-381. doi: 10.15326/jcopdf.2023.0472.
PubMed 38809105Wan ES, Polak M, Goldstein RL, Lazzari AA, Kantorowski A, Garshick E, Moy ML. Physical Activity, Exercise Capacity, and Body Composition in U.S. Veterans with Chronic Obstructive Pulmonary Disease. Ann Am Thorac Soc. 2022 Oct;19(10):1669-1676. doi: 10.1513/AnnalsATS.202111-1221OC.
PubMed 35536690Cruz Rivera PN, Goldstein RL, Polak M, Lazzari AA, Moy ML, Wan ES. Performance of bioelectrical impedance analysis compared to dual X-ray absorptiometry (DXA) in Veterans with COPD. Sci Rep. 2022 Feb 4;12(1):1946. doi: 10.1038/s41598-022-05887-4.
PubMed 35121763
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Physical Activity Promotion on Short and Long-term Outcomes in COPD
- ClinicalTrials.gov ID
- NCT02099799
- Acronym / sponsor ID
- WEB / O1150-R
- Conditions
- COPD, Emphysema, Chronic Bronchitis
- Keywords
- Physical Activity, COPD Self-Management, Internet, 6-Minute Walk Test, COPD Exacerbation, Health-related Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 17 Nov 2015 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 7 Feb 2020 (actual)
- First posted
- 31 Mar 2014 (estimated)
- Results
- Posted 14 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pedometer and Internet Website | Active comparator | Behavioral: Pedometer and WebsitePedometer and website with feedback, goal setting, educational and motivational content, and community forum. |
| Usual Care | No intervention | –Verbal instructions and written materials about exercise. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pedometer and WebsitePedometer and website with feedback, goal setting, educational and motivational content, and community forum. | Behavioural | Pedometer and Internet Website |
Primary outcome
6-Minute Walk Test Distance
Time frame: 6 months
In-clinic test that measures exercise capacity. Change in 6MWT distance at 6 months compared to baseline.
4 secondary outcomes
Health-related Quality of Life
Time frame: 6 months
Dyspnea
Time frame: 6 months
Engagement in Physical Activity
Time frame: 6 months
Inflammatory Biomarker Number 1
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19533541Moy ML, Matthess K, Stolzmann K, Reilly J, Garshick E. Free-living physical activity in COPD: assessment with accelerometer and activity checklist. J Rehabil Res Dev. 2009;46(2):277-86. doi: 10.1682/jrrd.2008.07.0083.
- Background: PubMed 20803392Moy ML, Janney AW, Nguyen HQ, Matthess KR, Cohen M, Garshick E, Richardson CR. Use of pedometer and Internet-mediated walking program in patients with chronic obstructive pulmonary disease. J Rehabil Res Dev. 2010;47(5):485-96. doi: 10.1682/jrrd.2009.07.0091.
- Background: PubMed 24308588Moy ML, Teylan M, Danilack VA, Gagnon DR, Garshick E. An index of daily step count and systemic inflammation predicts clinical outcomes in chronic obstructive pulmonary disease. Ann Am Thorac Soc. 2014 Feb;11(2):149-57. doi: 10.1513/AnnalsATS.201307-243OC.
- Background: PubMed 24152213Danilack VA, Weston NA, Richardson CR, Mori DL, Moy ML. Reasons persons with COPD do not walk and relationship with daily step count. COPD. 2014 Jun;11(3):290-9. doi: 10.3109/15412555.2013.841670. Epub 2013 Oct 23.
- Background: PubMed 24091482Moy ML, Teylan M, Weston NA, Gagnon DR, Danilack VA, Garshick E. Daily step count is associated with plasma C-reactive protein and IL-6 in a US cohort with COPD. Chest. 2014 Mar 1;145(3):542-550. doi: 10.1378/chest.13-1052.
- Background: PubMed 23593211Moy ML, Teylan M, Weston NA, Gagnon DR, Garshick E. Daily step count predicts acute exacerbations in a US cohort with COPD. PLoS One. 2013 Apr 4;8(4):e60400. doi: 10.1371/journal.pone.0060400. Print 2013.
- Background: PubMed 22521225Moy ML, Danilack VA, Weston NA, Garshick E. Daily step counts in a US cohort with COPD. Respir Med. 2012 Jul;106(7):962-9. doi: 10.1016/j.rmed.2012.03.016. Epub 2012 Apr 20.
- Background: PubMed 18712646Moy ML, Garshick E, Matthess KR, Lew R, Reilly JJ. Accuracy of uniaxial accelerometer in chronic obstructive pulmonary disease. J Rehabil Res Dev. 2008;45(4):611-7. doi: 10.1682/jrrd.2007.09.0147.
- Background: PubMed 25811395Moy ML, Collins RJ, Martinez CH, Kadri R, Roman P, Holleman RG, Kim HM, Nguyen HQ, Cohen MD, Goodrich DE, Giardino ND, Richardson CR. An Internet-Mediated Pedometer-Based Program Improves Health-Related Quality-of-Life Domains and Daily Step Counts in COPD: A Randomized Controlled Trial. Chest. 2015 Jul;148(1):128-137. doi: 10.1378/chest.14-1466.
- Derived from this study: PubMed 38809105Berube MN, Robinson SA, Wan ES, Mongiardo MA, Finer EB, Moy ML. Physical Activity and Systemic Biomarkers in Persons With COPD: Insights from a Web-Based Pedometer-Mediated Intervention. Chronic Obstr Pulm Dis. 2024 Jul 25;11(4):369-381. doi: 10.15326/jcopdf.2023.0472.
- Derived from this study: PubMed 35536690Wan ES, Polak M, Goldstein RL, Lazzari AA, Kantorowski A, Garshick E, Moy ML. Physical Activity, Exercise Capacity, and Body Composition in U.S. Veterans with Chronic Obstructive Pulmonary Disease. Ann Am Thorac Soc. 2022 Oct;19(10):1669-1676. doi: 10.1513/AnnalsATS.202111-1221OC.
- Derived from this study: PubMed 35121763Cruz Rivera PN, Goldstein RL, Polak M, Lazzari AA, Moy ML, Wan ES. Performance of bioelectrical impedance analysis compared to dual X-ray absorptiometry (DXA) in Veterans with COPD. Sci Rep. 2022 Feb 4;12(1):1946. doi: 10.1038/s41598-022-05887-4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marilyn L. Moy, MD principal investigator
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pedometer and Website in people with COPD and Emphysema, run by VA Office of Research and Development at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-Minute Walk Test Distance (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02099799, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2021.