COPD Access to Pulmonary Rehabilitation Intervention (CAPRI)

  • STATUS
    Recruiting
  • End date
    Apr 1, 2024
  • participants needed
    120
  • sponsor
    VA Office of Research and Development
Updated on 24 March 2022
dyspnea
rehabilitation therapy
bronchodilator
emphysema
pulmonary rehabilitation
cigarette smoke

Summary

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 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.

Description

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 cannot access conventional, hospital-based PR. The investigators also propose a non-randomized study to explore the ability of the PA intervention to maintain PA and exercise adherence, extending the benefits of PR, in persons with COPD who complete a conventional PR program. COPD is the third 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, and may be an option to maintain engagement in PA after patients complete a conventional 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 adherence, (b) exercise self-efficacy, (c) HRQL, (d) dyspnea, (e) anxiety and depression, and (f) risk of acute exacerbations and COPD-related hospitalizations, compared to usual care.

Exploratory Aim 3: Assess the ability of ESC to maintain PA and exercise adherence, and extend the benefits of PR, in participants with COPD who have completed conventional PR.

All study visits are performed virtually starting August 2020.

Details
Condition COPD
Treatment Every Step Counts
Clinical Study IdentifierNCT03794921
SponsorVA Office of Research and Development
Last Modified on24 March 2022

Eligibility

Yes No Not Sure

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 (FVC) < 0.70 or chest CT evidence of emphysema or prior documentation of FEV1/FVC ratio of < 0.7 and clinical evidence of COPD
defined as 10 pack-year cigarette smoking history
dyspnea
or on bronchodilators
Have declined participation in a conventional pulmonary rehabilitation program
Medical clearance from healthcare provider to participate in an exercise program
Have access to a computer with Internet connection, a USB port or Bluetooth capability, and Windows XP/Vista/7/8/10 or higher, or Mac OSX 10.5 or higher operating system, or willing to come to VA Medical Center to use study computers
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
Inability to ambulate with or without assistance
On supplemental oxygen
Use of walking assistive device
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
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