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Walking Program for COPD (CAPRI Trial)

N/A

Recruiting

Led By Marilyn L. Moy, MD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male and female subjects, greater than or equal to 40 years of age

Competent to provide informed consent

Must not have

On supplemental oxygen (if remote)

Inability to collect at least 7 of 10 days of baseline step counts

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks and 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether an Internet-mediated, pedometer-based walking program can help increase physical activity in persons with COPD who can't access regular pulmonary rehabilitation.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since the intervention involves a walking program, potential side effects may include muscle soreness or strain from increased physical activity. However, specific side effects are not detailed as it's a non-drug intervention.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 40 years old or older.

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I understand and can agree to the study's procedures and risks.

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I have chosen not to join or cannot access a lung rehab program.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I use supplemental oxygen.

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I cannot provide step counts for at least 7 out of 10 days.

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I cannot walk, even with help.

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I have had a worsening of my COPD in the last month.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks and 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks and 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Physical Activity measured as Daily Step Count

Secondary study objectives

Amount of Depression experienced by the participant

Exercise Self-Regulatory Efficacy

Health-Related Quality of Life using a disease specific questionnaire

+2 more

Other study objectives

Brief Pain Inventory

COPD Knowledge

Health Utilities

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Every Step Counts InterventionExperimental Treatment1 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 CareActive Control1 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.

0 / 7Eligibility criteria met