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Behavioural Intervention

Mindful Steps for COPD and Heart Failure

N/A
Waitlist Available
Research Sponsored by Beth Israel Deaconess Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Inability to collect at least 7 of 14 days of baseline step counts
Current participation in a cardiac or pulmonary rehabilitation program
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, months 3, 6, 12 and 15
Awards & highlights

Summary

This trial will test if an intervention called Mindful Steps can help COPD/HF patients to be more physically active, measured by step counts over 12 months. Participants will receive either Mindful Steps or usual care.

Who is the study for?
This trial is for patients with COPD or heart failure who can exercise, have an email and a device to use the Fitbit app. They need medical clearance and must not be in rehab or have had recent exacerbations.
What is being tested?
The study tests Mindful Steps, aiming to increase physical activity over 12 months compared to usual care. Participants are randomly assigned to either the intervention or control group, both receiving a health booklet.
What are the potential side effects?
Since this trial involves a mindfulness-based intervention rather than medication, side effects may include discomfort from increased physical activity but no drug-related side effects.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I can't provide 2 weeks of my daily step counts.
Select...
I am currently in a heart or lung rehab program.
Select...
I cannot walk on my own.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, months 3, 6, 12 and 15
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, months 3, 6, 12 and 15 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in physical activity
Secondary study objectives
Change in disease-specific quality-of-life
Change in dyspnea
Change in exercise engagement
+6 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Mindful StepsExperimental Treatment1 Intervention
Multi-modal web intervention including: pedometer with individualized step-count goals, motivational and educational content, online community forum, mind-body videos (short themed clips that support walking, plus library of mind-body exercises), online group mind-body exercise classes, star incentive system; educational booklet
Group II: Usual CareActive Control1 Intervention
Pragmatic usual care (standard care through participant's healthcare provider including pharmacological treatment and general advice for physical activity); educational booklet
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mindful Steps
2019
N/A
~50

Find a Location

Who is running the clinical trial?

VA Boston Healthcare SystemFED
70 Previous Clinical Trials
970,422 Total Patients Enrolled
University of MichiganOTHER
1,836 Previous Clinical Trials
6,428,030 Total Patients Enrolled
Beth Israel Deaconess Medical CenterLead Sponsor
850 Previous Clinical Trials
12,930,078 Total Patients Enrolled

Media Library

Mindful Steps (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05934565 — N/A
Chronic Obstructive Pulmonary Disease Research Study Groups: Mindful Steps, Usual Care
Chronic Obstructive Pulmonary Disease Clinical Trial 2023: Mindful Steps Highlights & Side Effects. Trial Name: NCT05934565 — N/A
Mindful Steps (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05934565 — N/A
~91 spots leftby Jun 2028
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