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

NCT02099799 | Completed Results DMC

• 1 other identifier: O1150-R
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 2

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.

Conditions

COPD; Emphysema; Chronic Bronchitis

Keywords

Physical Activity; COPD Self-Management; Internet; 6-Minute Walk Test; COPD Exacerbation; Health-related Quality of Life

Outcome Measures

Primary Outcomes (1)

• 6-Minute Walk Test Distance

  In-clinic test that measures exercise capacity. Change in 6MWT distance at 6 months compared to baseline.

  6 months

Secondary Outcomes (4)

• Health-related Quality of Life

  6 months

• Dyspnea

  6 months

• Engagement in Physical Activity

  6 months

• Inflammatory Biomarker Number 1

  6 months

Other Outcomes (1)

• Inflammatory Biomarker Number 2

  6 months

Study Arms (2)

Pedometer and Internet Website

ACTIVE COMPARATOR

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

Behavioral: Pedometer and Website

Usual Care

NO INTERVENTION

Verbal instructions and written materials about exercise.

Interventions

Pedometer and Website BEHAVIORAL

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

Pedometer and Internet Website

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (2)

Birmingham VA Medical Center, Birmingham, AL

Birmingham, Alabama, 35233, United States

Location

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

Boston, Massachusetts, 02130, United States

Location

Related Publications (12)

• 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.

  PMID: 19533541 BACKGROUND

• 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.

  PMID: 20803392 BACKGROUND

• 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.

  PMID: 24308588 BACKGROUND

• 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.

  PMID: 24152213 BACKGROUND

• 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.

  PMID: 24091482 BACKGROUND

• 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.

  PMID: 23593211 BACKGROUND

• 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.

  PMID: 22521225 BACKGROUND

• 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.

  PMID: 18712646 BACKGROUND

• 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.

  PMID: 25811395 BACKGROUND

• 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.

  PMID: 38809105 DERIVED

• 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.

  PMID: 35536690 DERIVED

• 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.

  PMID: 35121763 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Emphysema; Bronchitis, Chronic; Motor Activity

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Behavior

Limitations and Caveats

Strengths include the randomized study design, dual-site approach, and 6-month time frame. While the study expanded our past work with a more socioeconomically diverse sample, our cohort was self-selected and majority male, limiting generalizability.

Results Point of Contact

• Title: Marilyn Moy, MD, MSc
• Organization: VA Boston Healthcare System

marilyn.moy@va.gov

857-203-6622

Study Officials

• Marilyn L. Moy, MD

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Research assistant who assesses outcomes is blinded to randomization group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2014
• First Posted: March 31, 2014
• Study Start: November 17, 2015
• Primary Completion: November 1, 2019
• Study Completion: February 7, 2020
• Last Updated: September 5, 2021
• Results First Posted: January 14, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)