Study for Breathing Interventions in Congestive Heart Failure

NCT ID: NCT03449121

Last Updated: 2019-03-04

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-30
• Study Completion Date: 2019-05-31

Brief Summary

Slow breathing may reduce stress. Adults with congestive heart failure have higher stress than the general population. This study will examine if using slow breathing is feasible among adults with heart failure.

Conditions

Congestive Heart Failure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Slow breathing

Slow breathing techniques with exhale greater than inhale

Group Type: EXPERIMENTAL

Slow breathing techniques

Intervention Type: BEHAVIORAL

8 sessions of instruction in slow breathing exercises over 12 weeks of study

Interventions

Slow breathing techniques

8 sessions of instruction in slow breathing exercises over 12 weeks of study

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Documented heart failure from medical chart review with signs and symptoms consistent with disease
• Reduced left ventricular function with ejection fraction of less than or equal to 40%
• English speaking

Exclusion Criteria

• New York Heart Failure Association Class I or IV
• Myocardial infarction in the last 3 months
• Cardiac surgery in the last 3 months
• Significant valvular heart disease
• Uncontrolled cardiac arrhythmias
• Uncontrolled diabetes mellitus (hemoglobin a1c ≥ 8)
• Uncontrolled hypertension
• Systolic greater than 140 mmHg
• Diastolic greater than or 90 mmHg
• Cognitive impairment (Mini-mental state exam less than or equal to 24)
• Acute major depression in the last 3 months
• Other psychiatric conditions including schizophrenia or bipolar disorder
• Attention-deficit-disorder or attention-deficit-hyperactivity disorder
• Musculoskeletal condition limiting capacity to perform simple movements such as significant chronic lower back pain or neck pain
• Unstable or severe chronic lung conditions
• Current participation in a mind-body practice/program
• Current cancer other than non-melanoma skin cancer
• Regular swimmer
• Plays wind or brass musical instruments

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

171991

Identifier Type: -

Identifier Source: org_study_id