Breathing Intervention for Cardiac Anxiety

NCT02916550 | Terminated

• 1 other identifier: Laureateinstitute
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This study examines the impact of a breathing training intervention on cardiorespiratory sensations and anxiety in adults with cardiac arrhythmias.

Conditions

Atrial Fibrillation; Implantable Cardioverter Defibrillator

Outcome Measures

Primary Outcomes (1)

• Cardiac anxiety

  Assessed via the Cardiac Anxiety Questionnaire

  1 month

Secondary Outcomes (4)

• Disability

  1 month

• Wellbeing

  1 month

• ICD anxiety

  1 month

• Arrhythmia burden

  1 month

Study Arms (1)

Breathing exercise

EXPERIMENTAL

Participants will perform a paced breathing intervention (slow breathing) prompted by pseudorandomized remote reminders (scheduled reminders plus non scheduled reminders), through cellular phone application.

Behavioral: Breathing exercise

Interventions

Breathing exercise BEHAVIORAL

Participants will perform a paced breathing intervention (slow breathing) prompted by pseudorandomized remote reminders (scheduled reminders plus non scheduled reminders), through cellular phone application.

Breathing exercise

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 to 80
• BMI 17 to 35
• Proficient in English language
• Paroxysmal atrial fibrillation or ventricular fibrillation or frequent premature atrial/ventricular contractions

You may not qualify if:

• No telephone access
• Active suicidal ideation with intent or plan
• Active drug or alcohol dependence, or active binge drinking within the last month
• Cardiovascular instability, as evidenced any of the following:
• New York Heart Association (NHYA) heart failure class IV (i.e., unable to carry on any physical activity without discomfort, symptoms of heart failure at rest, increased discomfort with any physical activity is undertaken)
• American College of Cardiology/American Heart Association congestive heart failure stage D (i.e., heart failure symptoms at rest, receiving end of life care).
• Unstable angina or exercise induced angina
• Persistent atrial fibrillation
• Pacemakers or combined pacemaker/ICDs will be excluded
• Presence of unstable cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, or metabolic disease; or any other condition that, in the opinion of the investigator, would make participation not be in the best interest (e.g., compromise the well-being) of the subject or that could prevent, limit, or confound the protocol-specified assessments.

Sponsors & Collaborators

• Laureate Institute for Brain Research, Inc.: lead
• University of Arizona: collaborator

Study Sites (1)

Laureate Institute for Brain Research

Tulsa, Oklahoma, 74136, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Sahib Khalsa, MD, PhD

  Laureate Institute for Brain Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2016
• First Posted: September 27, 2016
• Study Start: September 1, 2016
• Primary Completion: September 1, 2021
• Study Completion: May 1, 2023
• Last Updated: October 6, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)