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Behavioral Intervention
Home-Based Pulmonary Rehabilitation for COPD
N/A
Waitlist Available
Led By Roberto P Benzo, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 40+
Be older than 18 years old
Must not have
- Inability to walk (orthopedic-neurologic problems or confined to bed)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 3 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is comparing the effectiveness of two types of pulmonary rehabilitation programs.
Who is the study for?
This trial is for individuals over 40 years old who have been hospitalized due to Chronic Obstructive Pulmonary Disease (COPD) and are eligible for Pulmonary Rehabilitation (PR). Participants must feel confident (scoring above a 5 on a self-efficacy scale of 1-10) about using the system daily. Those unable to walk due to orthopedic-neurologic issues or being bedridden cannot join.
What is being tested?
The study compares two approaches: home-based PR with new technology and health coaching, versus traditional referral to center-based PR which may also offer telehealth options. The goal is to see which method better encourages patients to stick with their rehabilitation after leaving the hospital.
What are the potential side effects?
Since this intervention involves exercise and health coaching rather than medication, side effects might include muscle soreness or fatigue from physical activity. However, specific side effects will depend on individual health conditions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 40 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I cannot walk due to orthopedic or neurologic reasons, or I am bedridden.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 3 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Adherence to Pulmonary Rehabilitation
Secondary study objectives
Daily Physical Activity
Duke-UNC Functional Social Support Questionnaire (FSSQ)
Health Care Utilization
+3 moreAwards & 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: Intervention- Home Pulmonary RehabilitationExperimental Treatment1 Intervention
Participants enrolled in the intervention arm will be offered a Home-based pulmonary rehabilitation program with health coaching.
Group II: Control- ChoiceActive Control1 Intervention
This arm receives the standard of care which includes the choice of PR at a facility or through telehealth. Center based PR involves attending a medical center gym where they can do exercises and receive disease specific education. Telehealth PR is delivered virtually through the computer or telephone.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Intervention- Home-based Pulmonary Rehabilitation
2018
N/A
~10
Find a Location
Who is running the clinical trial?
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,939 Previous Clinical Trials
47,792,252 Total Patients Enrolled
Mayo ClinicLead Sponsor
3,354 Previous Clinical Trials
3,060,872 Total Patients Enrolled
Roberto P Benzo, MDPrincipal InvestigatorMayo Clinic
2 Previous Clinical Trials
36 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 40 years old or older.You feel very confident (score of more than 5 out of 10) using the system every day.I have been hospitalized for COPD and am eligible for pulmonary rehabilitation.I cannot walk due to orthopedic or neurologic reasons, or I am bedridden.
Research Study Groups:
This trial has the following groups:- Group 1: Control- Choice
- Group 2: Intervention- Home Pulmonary Rehabilitation
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.