The Effect of Physical Activity Promotion on Short and Long-term Outcomes in COPD

NCT ID: NCT02099799

Last Updated: 2021-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 153 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-17
• Study Completion Date: 2020-02-07

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.

Conditions

COPD; Emphysema; Chronic Bronchitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Pedometer and Internet Website

Pedometer and website with feedback, goal setting, educational and motivational content, and community forum.

Group Type: ACTIVE_COMPARATOR

Pedometer and Website

Intervention Type: BEHAVIORAL

Pedometer and website with feedback, goal setting, educational and motivational content, and community forum.

Usual Care

Verbal instructions and written materials about exercise.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Pedometer and Website

Pedometer and website with feedback, goal setting, educational and motivational content, and community forum.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marilyn L. Moy, MD

Role: PRINCIPAL_INVESTIGATOR

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Locations

Birmingham VA Medical Center, Birmingham, AL

Birmingham, Alabama, United States

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Boston, Massachusetts, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 19533541 (View on PubMed)

Moy 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.

Reference Type: BACKGROUND

PMID: 20803392 (View on PubMed)

Moy 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.

Reference Type: BACKGROUND

PMID: 24308588 (View on PubMed)

Danilack 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.

Reference Type: BACKGROUND

PMID: 24152213 (View on PubMed)

Moy 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.

Reference Type: BACKGROUND

PMID: 24091482 (View on PubMed)

Moy 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.

Reference Type: BACKGROUND

PMID: 23593211 (View on PubMed)

Moy 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.

Reference Type: BACKGROUND

PMID: 22521225 (View on PubMed)

Moy 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.

Reference Type: BACKGROUND

PMID: 18712646 (View on PubMed)

Moy 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.

Reference Type: BACKGROUND

PMID: 25811395 (View on PubMed)

Berube 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.

Reference Type: DERIVED

PMID: 38809105 (View on PubMed)

Wan 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.

Reference Type: DERIVED

PMID: 35536690 (View on PubMed)

Cruz 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.

Reference Type: DERIVED

PMID: 35121763 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

O1150-R

Identifier Type: -

Identifier Source: org_study_id