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OpenTrials
Completed

NCT Number: NCT03003780

Mindful Steps: Promoting Physical Activity

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).

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Key information

Conditions

COPD Cardiovascular Diseases Chronic Disease Disease Attributes Heart Diseases Heart Failure Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

BIDMC

Boston, Massachusetts, 02215, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mindful Steps

Behavioral

Integrated website, activity tracker, and mind-body training

Primary outcomes

  1. Feasibility

    Time frame: 6 months

    intervention acceptability (qualitative interview)

Secondary outcomes

  1. Self-efficacy

    Time frame: baseline, months 3, 6, 9 and 12

    change in self-efficacy between time points (exercise self-efficacy scale)

  2. Physical activity

    Time frame: baseline, months 3,6,9, and 12

    change in physical activity between time points (physical activity questionnaire)

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Dec 28, 2016
Registry last updated
Jan 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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