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Mindful Steps: Promoting Physical Activity

Mindful Steps: Coupling Technology and Mind-Body Exercise to Facilitate Physical Activity in Patients With Cardiopulmonary Disease

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03003780
Enrollment
42
Registered
2016-12-28
Start date
2019-01-02
Completion date
2021-07-06
Last updated
2023-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Copd, Heart Failure

Brief summary

This is a developmental project with two phases. The first phase will adapt an existing web-based intervention to incorporate mind-body exercises to develop a multi-modal intervention to promote physical activity in patients with COPD and HF. The second phase will pilot test this new intervention in a longitudinal study (subjects randomized to intervention or usual care).

Interventions

BEHAVIORALMindful Steps

Integrated website, activity tracker, and mind-body training

Sponsors

Beth Israel Deaconess Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Clinical diagnosis of COPD OR clinical diagnosis of HF syndrome (New York Heart Association Class 1-3) * Able to participate in an exercise program * Have an active email account and access to a computer with internet connection

Exclusion criteria

* COPD or HF exacerbation in the previous month * Inability to ambulate * Clinical signs of unstable cardiovascular disease * Hypoxemia during 6MWT * Inability to collect at least 7 of 14 days of baseline step counts * Current participation in a cardiac or pulmonary rehabilitation program.

Design outcomes

Primary

MeasureTime frameDescription
Feasibility6 monthsintervention acceptability (qualitative interview)

Secondary

MeasureTime frameDescription
Self-efficacybaseline, months 3, 6, 9 and 12change in self-efficacy between time points (exercise self-efficacy scale)
Physical activitybaseline, months 3,6,9, and 12change in physical activity between time points (physical activity questionnaire)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 16, 2026