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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if an online walking program, called Every Step Counts, using a pedometer, can help people with COPD (a lung disease that makes breathing difficult) become more active. It compares this program to usual care, where participants receive general advice to increase exercise. The trial seeks individuals with COPD who have difficulty accessing traditional rehab programs and experience breathing issues or use inhalers. Participants need internet access and a computer. This research aims to improve quality of life by encouraging more activity. As an unphased trial, this study offers a unique opportunity to contribute to research that could lead to new ways of managing COPD and enhancing daily life.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that this walking program is safe for individuals with COPD?

Research has shown that the "Every Step Counts" walking program is safe for people with Chronic Obstructive Pulmonary Disease (COPD). A small initial study found that increasing daily walking with this program is both feasible and safe. Impressively, 95% of participants recommended it to others with COPD. Some participants experienced breathing problems, but these were not caused by the program itself. Overall, evidence suggests that the "Every Step Counts" program is well-received. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the "Every Step Counts" program because it offers a fresh, tech-driven approach to managing COPD compared to traditional pulmonary rehab. Unlike standard care that often involves in-person sessions, this program uses a pedometer and an online platform to set personalized step goals, making it more accessible and flexible for patients. This method empowers individuals to track their progress and adjust their activity levels at their own pace, potentially enhancing adherence and outcomes. By leveraging technology, "Every Step Counts" aims to make exercise a more integral and achievable part of daily life for those with COPD.

What evidence suggests that this walking program is effective for COPD?

Research shows that using a pedometer to track steps can greatly benefit people with COPD (chronic obstructive pulmonary disease). Studies have found that counting daily steps can enhance lung function and daily activity levels. A review of 14 studies found that step counters help people with COPD become more active and improve their exercise capacity. Taking more steps each day is also linked to a lower risk of sudden symptom flare-ups and reduced death rates in people with COPD. In this trial, participants in the "Every Step Counts" intervention arm will use a pedometer to track their steps and receive personalized step-count goals. These findings suggest that the "Every Step Counts" walking program could effectively boost health and activity for those who qualify for pulmonary rehabilitation but can't access it. ^{1 3 6 7 8}

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+

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S0954611112002272

A pilot study of an Internet walking program and pedometer ... At month 3, 96% reported it was true that they knew their step count goal every day, and 52% reported that they were able to reach their goal. 95% of ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9026463/

Effects of a Pedometer-Based Walking Program in Patients ... Conclusions: For patients with COPD, a daily walking program with a pedometer is beneficial in the improvement of pulmonary function, daily ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02099799

The Effect of Physical Activity Promotion on Short and Long ... A higher daily step count, when directly measured, is associated with lower risk of acute exacerbations (AEs) and mortality in COPD, independent of lung ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6048621/

Using step counters to promote physical activity and ... This meta-analysis of 14 RCTs shows that step counter use was effective in increasing physical activity and improving exercise capacity in patients with COPD.

5. atsjournals.org atsjournals.org/doi/10.1164/rccm.201607-1372OC

Pedometer Step Count Targets during Pulmonary ... Conclusions: Pedometer-directed step-count targets during an outpatient PR program did not enhance moderate-intensity physical activity levels ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/22795984/

A pilot study of an Internet walking program and pedometer ... 95% of participants said they would recommend the walking program to another person with COPD. Eight subjects experienced breathing problems unrelated to the ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06629675?cond=%22Lung%20Diseases,%20Obstructive%22&aggFilters=status:not%20rec&rank=4

Make Every Step Count: Personalised Music Feedback to ... The aims of PR are to improve symptoms of COPD, increase exercise capacity, increase independency, improve overall behaviour related to health (like exercising ...

8. resmedjournal.com resmedjournal.com/article/S0954-6111(12)00227-2/pdf

A pilot study of an Internet walking program and pedometer ... We have extended SUH to include website content specific for persons with COPD. This adapted walking program is called. Every Step Counts (ESC) ...