Mindful Steps 2.0: Promoting Physical Activity in Patients With COPD and HF
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorBeth Israel Deaconess Medical Center
About this trial
The goal of this fully-remote randomized controlled trial is to test the efficacy of Mindful Steps in facilitating physical activity compared to usual standard of care among 136 patients with COPD and/or HF. The main question it aims to answer is can this intervention promote physical activity as measured by daily step counts in sedentary patients with COPD and/or HF. Participants will be randomized (1:1 ratio) to receive either the Mindful Steps intervention or usual care for 12 months, with both arms receiving a Walking for Health education booklet.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Clinical diagnosis of COPD (defined as cigarette smoking history > 10 pack-years, and either a ratio of FEV1 to forced vital capacity < 0.70 or chest CT evidence of emphysema) OR clinical diagnosis of HF syndrome (with left ventricular systolic dysfunction or preserved ejection fraction and New York Heart Association Class 1-3)
Medical clearance from provider to participate in an exercise program
Have an active email account; access to a computer device (desktop, laptop, tablet, or smartphone that supports the Fitbit app).
Disqualifiers
COPD or HF exacerbation in the previous month
Inability to ambulate
Inability to collect at least 7 of 14 days of baseline step counts
Current participation in a cardiac or pulmonary rehabilitation program
Trial design
Design model
Parallel
Treatments tested in this trial
Mindful Steps
BehavioralIntegrated website, activity tracker, and mind-body training
Treatment groups
136 Participants
are divided into 2 treatment groupsGroup A: Mindful StepsExperimental treatment 1 intervention
Group B: Usual CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Change in physical activity
Daily step counts will be measured as an objective proxy for physical activity using FitBit pedometers (FitBit Inspire 3)
Time frame
baseline, months 3, 6, 12, and 15Secondary outcomes
1
Change in self-efficacy
Exercise self-efficacy will be measured using the Self-Efficacy for Exercise Scale and the Self-Efficacy for Managing Chronic Disease Scale. The Self-Efficacy for Exercise Scale a 9-item validated scale; scores range from 9-28, with a higher score meaning more self-efficacy. The Self-Efficacy for Managing Chronic Disease Scale is a 6-item visual analog scale; scores range from 1-10, with a higher score indicating higher self-efficacy.
Time frame
baseline, months 3, 6, 12, and 152
Change in intrinsic motivation
Intrinsic motivation will be measured using the Intrinsic Motivation Inventory. This is a 22-item scale validated with four sub-scales: interest/enjoyment, perceived competence, perceived choice, and pressure/tension. A higher score is better, with a scoring range of 22-154.
Time frame
baseline, months 3, 6, 12, and 153
Qualitative inquiry
Half-hour semi-structured qualitative interviews guided by study staff will be conducted over video/phone in a random subset of 50 participants at the 6 and 12 month timepoints.
Time frame
months 6 and 124
Change in disease-specific quality-of-life
Disease-specific quality-of-life will be measured using St. George's Respiratory Questionnaire (SGRQ) and The Minnesota Living with Heart Failure Questionnaire (MLFHQ). The SGRQ is a 50-item instrument developed and validated in COPD and calculates four scores: symptomatology, activity, impacts and an overall metric; scores range from 0-100, with higher scores indicating more limitations. The MLFHQ is a 21-item instrument; total scores range from 0-105, with higher scores indicating poorer quality-of-life.
Time frame
baseline, months 3, 6, 12, and 15Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Beth Israel Deaconess Medical Center
Lead sponsor
Brigham and Women's Hospital
Collaborator
VA Boston Healthcare System
Collaborator
University of Michigan
Collaborator
Source ClinicalTrials.gov