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Trial record 17 of 30 for:    Developmental Disabilities | ( Map: Alabama, United States )

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02099799
Recruitment Status : Completed
First Posted : March 31, 2014
Last Update Posted : March 23, 2020
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Tracking Information
First Submitted Date  ICMJE March 20, 2014
First Posted Date  ICMJE March 31, 2014
Last Update Posted Date March 23, 2020
Actual Study Start Date  ICMJE November 17, 2015
Actual Primary Completion Date November 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 28, 2017)
6-Minute Walk Test Distance [ Time Frame: 6 months ]
In-clinic test that measures exercise capacity.
Original Primary Outcome Measures  ICMJE
 (submitted: March 26, 2014)
6-Minute Walk Test Distance [ Time Frame: 12 months ]
In-clinic test that measures exercise capacity.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 28, 2017)
  • Health-related Quality of Life [ Time Frame: 6 months ]
    Questionnaires that assess quality of life.
  • Number of Acute Exacerbations and Hospitalizations [ Time Frame: 6 months ]
    Assessed by patient report and review of medical records.
  • Dyspnea [ Time Frame: 6 months ]
    Assessed by questionnaire that measure breathlessness and shortness of breath.
  • Inflammatory Biomarkers IL-6 and CRP [ Time Frame: 6 months ]
    Participant has blood draw at in-clinic visits. Blood test measures markers of systemic inflammation.
  • Engagement in Physical Activity [ Time Frame: 6 months ]
    Assessed by daily step counts on pedometer.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 26, 2014)
  • Health-related Quality of Life [ Time Frame: 12 months ]
    Questionnaires that assess quality of life.
  • Number of Acute Exacerbations and Hospitalizations [ Time Frame: 12 months ]
    Assessed by patient report and review of medical records.
  • Dyspnea [ Time Frame: 12 months ]
    Assessed by questionnaire that measure breathlessness and shortness of breath.
  • Inflammatory Biomarkers IL-6 and CRP [ Time Frame: 12 months ]
    Participant has blood draw at in-clinic visits. Blood test measures markers of systemic inflammation.
  • Engagement in Physical Activity [ Time Frame: 12 months ]
    Assessed by daily step counts on pedometer.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Physical Activity Promotion on Short and Long-term Outcomes in COPD
Official Title  ICMJE The Effect of Physical Activity Promotion on Short and Long-term Outcomes in COPD
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description:
Research assistant who assesses outcomes is blinded to randomization group.
Primary Purpose: Treatment
Condition  ICMJE
  • COPD
  • Emphysema
  • Chronic Bronchitis
Intervention  ICMJE Behavioral: Pedometer and Website
Pedometer and website with feedback, goal setting, educational and motivational content, and community forum.
Study Arms  ICMJE
  • Active Comparator: Pedometer and Internet Website
    Pedometer and website with feedback, goal setting, educational and motivational content, and community forum.
    Intervention: Behavioral: Pedometer and Website
  • No Intervention: Usual Care
    Verbal instructions and written materials about exercise.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 19, 2020)
153
Original Estimated Enrollment  ICMJE
 (submitted: March 26, 2014)
185
Actual Study Completion Date  ICMJE February 7, 2020
Actual Primary Completion Date November 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02099799
Other Study ID Numbers  ICMJE O1150-R
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party VA Office of Research and Development
Study Sponsor  ICMJE VA Office of Research and Development
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Marilyn L. Moy, MD VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
PRS Account VA Office of Research and Development
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP