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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, months 3, 6, 12 and 15
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in physical activity
Secondary outcome measures
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
69 Previous Clinical Trials
970,356 Total Patients Enrolled
University of MichiganOTHER
1,808 Previous Clinical Trials
6,384,637 Total Patients Enrolled
Beth Israel Deaconess Medical CenterLead Sponsor
839 Previous Clinical Trials
13,010,290 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still openings available for participants in this experiment?

"According to clinicaltrials.gov, this study is not presently enrolling participants. Initially posted on June 30th 2024 and revised lastly on June 28th 2023, the trial has yet to begin recruiting for candidates; however there are 383 other trials currently registering patients at present."

Answered by AI
~91 spots leftby Jun 2028