Walking Program for COPD

(CAPRI Trial)

Overseen By Niquel Ortega

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Must be taking: Bronchodilators

Disqualifiers: COPD exacerbation, Supplemental oxygen, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

103 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Marilyn L Moy, MD

Principal Investigator

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

Are You a Good Fit for This Trial?

This trial is for adults over 40 with COPD, a history of smoking, and difficulty breathing who can't access traditional pulmonary rehab. They must be able to exercise, have internet and computer access, and not use walking aids or supplemental oxygen remotely. They shouldn't be in another exercise study or have done pulmonary rehab recently.

Inclusion Criteria

I am 40 years old or older.

Medical clearance from healthcare provider to participate in an exercise program

I have been diagnosed with COPD based on lung function tests or a chest CT.

Exclusion Criteria

I use supplemental oxygen.

You typically take at least 10,000 steps per week.

You have plans to join a research study about exercise within the next 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a 12-week web-based intervention, Every Step Counts (ESC), to increase physical activity using a pedometer and online platform

12 weeks

Weekly data uploads (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of acute exacerbations and hospitalizations

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Every Step Counts

Trial Overview The trial tests an online pedometer-based walking program called 'Every Step Counts' against usual care for people with COPD who can't attend conventional rehabilitation programs. It aims to improve physical activity and quality of life through remote intervention.

How Is the Trial Designed?

Group I: Every Step Counts Intervention Experimental Treatment 1 Intervention

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.

Group II: Usual Care Active Control 1 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.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+