Mindful Steps: Promoting Physical Activity

January 6, 2023 updated by: Gloria Y. Yeh, Beth Israel Deaconess Medical Center

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • BIDMC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual Care
Experimental: Mindful Steps
Web-based behavioral intervention
Behavioral: Mindful Steps
Integrated website, activity tracker, and mind-body training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility
Time Frame: 6 months
intervention acceptability (qualitative interview)
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-efficacy
Time Frame: baseline, months 3, 6, 9 and 12
change in self-efficacy between time points (exercise self-efficacy scale)
baseline, months 3, 6, 9 and 12
Physical activity
Time Frame: baseline, months 3,6,9, and 12
change in physical activity between time points (physical activity questionnaire)
baseline, months 3,6,9, and 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beth Israel Deaconess Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2019

Primary Completion (Actual)

July 6, 2021

Study Completion (Actual)

July 6, 2021

Study Registration Dates

First Submitted

December 13, 2016

First Submitted That Met QC Criteria

December 22, 2016

First Posted (Estimate)

December 28, 2016

Study Record Updates

Last Update Posted (Estimate)

January 9, 2023

Last Update Submitted That Met QC Criteria

January 6, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016P000368

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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