COPD Access to Pulmonary Rehabilitation Intervention

NCT03794921 | Completed Results DMC

• 2 other identifiers: F2855-RI01RX002855
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

Brief 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 qualify for but 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.

Conditions

COPD

Keywords

Pulmonary Rehabilitation; Technology-Mediated; Web-Based Intervention; Physical Activity

Outcome Measures

Primary Outcomes (1)

• Physical Activity Measured as Change in Average Daily Step Count

  Daily Step Count was directly measured with a wearable monitoring device. Change in daily step count at 12 weeks compared to baseline from the adjusted mixed model.

  12 weeks compared to baseline

Secondary Outcomes (8)

• Exercise Self-Regulatory Efficacy Measured as Change Score

  12 weeks compared to baseline

• Disease Specific Health-Related Quality of Life Measured as Change Score

  12 weeks compared to baseline

• Shortness of Breath Rating as Perceived by the Participant Measured as Change Score

  12 weeks compared to baseline

• Depression Self-reported on Questionnaire Measured as Change Score

  12 weeks compared to baseline

• CHAMPS Physical Activity Questionnaire Measured as Change Score

  12 weeks compared to baseline

Other Outcomes (7)

• Health Utilities Measured as Change Score

  12 weeks compared to baseline

• Number of Participants Who Plan to Enroll in Conventional Pulmonary Rehabilitation After Participating in the Research Study

  12 weeks

• COPD Knowledge Measured as Change Score

  12 weeks compared to baseline

Study Arms (2)

Usual Care

NO INTERVENTION

Patients referred to conventional PR or eligible for PR but declined or cannot access. Using a standardized script at the randomization phone call, study staff will deliver verbal instructions to slowly and steadily increase one's walking and exercise each week. Participants will be asked to perform exercise of moderate intensity for at least 30 minutes on most days of the week, defined as a dyspnea level of 4-5 on the Borg scale and taking 1-2 minutes to recover. Use of the Borg rating scale for dyspnea will be reviewed with each participant. Exercise is defined as planned PA, outside of activities performed as part of one's daily routine. Exercise can be walking in the community or using exercise equipment at a local gym. Adapted written materials reinforce the verbal instructions. Participants will receive this 45-page spiral-bound book with information about aerobic and strength training exercises.

Every Step Counts Intervention

EXPERIMENTAL

Patients referred to conventional PR or eligible for PR but declined or cannot access. After randomization to ESC, participants will be mailed detailed instructions about the website. They will be asked to wear the lightweight, unobtrusive pedometer every day, except while asleep or showering/bathing, during the 12-week intervention period. Subjects will be instructed to upload their date and time-stamped step-count data to the study website at least weekly. Each week, the study computer will run the goal calculation algorithm and provide each participant with his/her daily step-count goal for the week. The week's step-count goal will be displayed on each subject's personal study web page. Participants will be instructed to exercise and reach their individualized step-count goals with walking of moderate intensity for at least 30 minutes on most days of the week, defined as a dyspnea level of 4-5 on the Borg scale and taking 1-2 minutes to recover.

Other: Every Step Counts

Interventions

Every Step Counts OTHER

Pedometer coupled to a website that provides step-count goals, feedback, education, motivation, and social support.

Every Step Counts Intervention

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: 1 of the following as testing-based evidence of COPD (any documented FEV1/FVC \< 0.70, chest CT evidence of emphysema) AND at least 2 of the following as clinical evidence of COPD (≥ 10 pack-year cigarette smoking history, taking an antimuscarinic inhaler such as ipratropium or tiotropium, diagnosis of COPD written in a provider's note or on problem list)
• Have declined participation in a conventional pulmonary rehabilitation program
• Medical clearance from healthcare provider to participate in an exercise program
• Have Internet connection and Bluetooth capability, and access to video platform Cisco Webex#
• Answer yes to "Does your shortness of breath interfere with your functioning?"
• Answer no to "Are you interested in joining PR now? If they answer yes, they will be ineligible and the PI will place a consult to PR for further evaluation
• 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
• Prescribed supplemental oxygen for activity+
• Inability to ambulate with or without assistance
• Use of assistive device for walking such as cane or walker\*
• 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
• For those who wish to participate virtually.
• If participant has an in-person visit, oxygen will be assessed during the 6MWT to determine if subject's oxygen is stable during activity. If a participant has an in-person visit and oxygen is documented during the 6MWT and stays above 85%, he/she will be eligible to participate.
• If a participant uses an assistive walking device but we have previously shown that the Fitbit pedometer is accurate in him/her (before the study was transitioned to virtual) he/she will be allowed to participate in the study. If a participant has an in-person visit and Fitbit accuracy is documented during use of the assistive device he/she will be eligible to participate.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

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

Boston, Massachusetts, 02130-4817, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Motor Activity

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

First, changes such as how visits were conducted were made to the study protocol after the trial was underway due to the COVID-19 pandemic. Second, walking intensity was not objectively measured. Third, the lack of racial and ethnic diversity and paucity of women limits generalizability of results.

Results Point of Contact

• Title: Marilyn Moy, MD
• 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: Study staff communicating randomization assignments to subjects will be different from study staff conducting follow-up outcome assessments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: As the primary aim, the investigators propose a RCT to study the efficacy of a web-based, pedometer-mediated physical activity intervention to increase physical activity in persons with COPD who would benefit from but cannot access conventional pulmonary rehabilitation, compared to usual care. The investigators anticipate that 120 subjects will be randomized 1:1 to either the intervention or usual care.

Study Record Dates

• First Submitted: December 18, 2018
• First Posted: January 7, 2019
• Study Start: September 17, 2019
• Primary Completion: September 10, 2024
• Study Completion: September 10, 2024
• Last Updated: April 2, 2026
• Results First Posted: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)