Mindful Steps: Promoting Physical Activity

NCT ID: NCT03003780

Last Updated: 2023-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-02

Study Completion Date

2021-07-06

Brief Summary

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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).

Detailed Description

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Conditions

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Copd Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Mindful Steps

Web-based behavioral intervention

Group Type EXPERIMENTAL

Mindful Steps

Intervention Type BEHAVIORAL

Integrated website, activity tracker, and mind-body training

Usual Care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Mindful Steps

Integrated website, activity tracker, and mind-body training

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beth Israel Deaconess Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Gloria Y. Yeh

Associate Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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BIDMC

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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Kraemer KM, Litrownik D, Wayne PM, Richardson CR, Bhomia N, Kadri R, Rist PM, Ngo L, Moy ML, Yeh GY. Promoting Walking in Cardiopulmonary Disease With Mindful Steps: Pilot Feasibility Randomized Controlled Trial of a Web-Based, Pedometer-Mediated Mind-Body Intervention. JMIR Form Res. 2025 Oct 28;9:e74118. doi: 10.2196/74118.

Reference Type DERIVED
PMID: 41147625 (View on PubMed)

Litrownik D, Gilliam EA, Wayne PM, Richardson CR, Kadri R, Rist PM, Moy ML, Yeh GY. Development of a Novel Intervention (Mindful Steps) to Promote Long-Term Walking Behavior in Chronic Cardiopulmonary Disease: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2021 Apr 29;10(4):e27826. doi: 10.2196/27826.

Reference Type DERIVED
PMID: 33913819 (View on PubMed)

Other Identifiers

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2016P000368

Identifier Type: -

Identifier Source: org_study_id

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