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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
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks and 6 months
Awards & highlights
CAPRI Trial 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.Check my eligibility
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.See study design
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.
CAPRI Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 40 years old or older.
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I have been diagnosed with COPD based on lung function tests or a chest CT.
Select...
I am willing to attend all follow-up visits and be reachable by phone for the study period.
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I have smoked for 10 years, experience shortness of breath, or use inhalers.
Select...
I understand and can agree to the study's procedures and risks.
Select...
I have chosen not to join or cannot access a lung rehab program.
CAPRI Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Physical Activity measured as Daily Step Count
Secondary outcome measures
Amount of Depression experienced by the participant
Exercise Self-Regulatory Efficacy
Health-Related Quality of Life using a disease specific questionnaire
+2 moreOther outcome measures
Brief Pain Inventory
COPD Knowledge
Health Utilities
+3 moreCAPRI 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.
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Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,306,483 Total Patients Enrolled
Marilyn L. Moy, MDPrincipal InvestigatorVA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
3 Previous Clinical Trials
319 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I use supplemental oxygen.You typically take at least 10,000 steps per week.I am 40 years old or older.I have been diagnosed with COPD based on lung function tests or a chest CT.You have plans to join a research study about exercise within the next 3 months.I cannot provide step counts for at least 7 out of 10 days.I cannot walk, even with help.I am willing to attend all follow-up visits and be reachable by phone for the study period.I have been part of a lung rehab program recently.I have smoked for 10 years, experience shortness of breath, or use inhalers.I understand and can agree to the study's procedures and risks.I use a device to help me walk.I have chosen not to join or cannot access a lung rehab program.I have had a worsening of my COPD in the last month.
Research Study Groups:
This trial has the following groups:- Group 1: Usual Care
- Group 2: Every Step Counts Intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are enrollment opportunities for this clinical trial still available?
"Per clinicaltrials.gov, this experiment is presently recruiting test subjects. It was initially posted on September 2nd 2019 and underwent a most recent update November 8th 2022."
Answered by AI
How many participants are currently being enrolled in this research project?
"Yes, the information on clinicaltrials.gov affirms that this medical trial is still recruiting participants. It was first posted on September 2nd 2019 and last updated November 8th 2022, with a requirement of 120 subjects from one location."
Answered by AI
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