Study for Breathing Interventions in Congestive Heart Failure

Pilot Study for Breathing Interventions in Congestive Heart Failure

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.

Study Overview

• Status: Withdrawn
• Conditions: Congestive Heart Failure
• Intervention / Treatment: Behavioral: Slow breathing techniques

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Slow breathing; Slow breathing techniques with exhale greater than inhale	Behavioral: Slow breathing techniques; 8 sessions of instruction in slow breathing exercises over 12 weeks of study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of intervention administration measured by frequency of visits	Investigators will document weekly attendance	Weekly for 12 weeks
Feasibility of intervention administration measured by home practice adherence	Investigators will ask participants how often they practiced yoga at home since last session	Weekly for 12 weeks
Feasibility of intervention administration measured by patient satisfaction	A survey will be administered that assesses participant satisfaction with the yoga. Overall satisfaction will be assessed by "Very Unsatisfied", "Unsatisfied", "Satisfied", "Very Satisfied".	One time, at 12 week survey
Safety of yoga practice as measured by occurrence of adverse events	Investigators will monitor for adverse events related to yoga practice during the intervention and will solicit any adverse events during home practice since last meeting.	Weekly for 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Magnitude of change in PROMIS Depression scale	Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Computer Adaptive Test (CAT). The PROMIS Depression instruments assess self-reported negative mood (sadness, guilt), views of self (selfcriticism, worthlessness), and social cognition (loneliness, interpersonal alienation), as well as decreased positive affect and engagement (loss of interest, meaning, and purpose). With CAT, participant responses guide the system's choice of subsequent items from the full item bank (28 items in total) and a T-Score is generated. T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. A higher score reflects higher levels of depression.	Baseline, 6 week, 12 week
Magnitude of change in PROMIS Anxiety scale	Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Computer Adaptive Test (CAT). The PROMIS Anxiety instruments measure self-reported fear (fearfulness, panic), anxious misery (worry, dread), hyperarousal (tension, nervousness, restlessness), and somatic symptoms related to arousal (racing heart, dizziness). With CAT, participant responses guide the system's choice of subsequent items from the full item bank (29 items in total) and a T-Score is generated. T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. A higher score reflects higher levels of anxiety.	Baseline, 6 week, 12 week
Magnitude of change in PROMIS Global Health scale	Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health. The PROMIS Global Health measures assess an individual's physical, mental, and social health. Each of the 10 items are totaled into a raw sum score and Raw Sum Scores are then converted into T-Scores. T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. A higher score reflects higher levels of physical, mental, and social health.	Baseline, 6 week, 12 week
Magnitude of change in PROMIS Physical Function scale	Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Computer Adaptive Test (CAT). PROMIS Physical Function instruments measure self-reported capability rather than actual performance of physical activities. This includes the functioning of one's upper extremities (dexterity), lower extremities (walking or mobility), and central regions (neck, back), as well as instrumental activities of daily living, such as running errands. With CAT, participant responses guide the system's choice of subsequent items from the full item bank (165 items in total) and a T-Score is generated. T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. A higher score reflects higher levels of physical functioning.	Baseline, 6 week, 12 week
Magnitude of change in PROMIS Fatigue scale	Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Computer Adaptive Test (CAT). The PROMIS Fatigue instruments evaluate a range of self-reported symptoms, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social roles. With CAT, participant responses guide the system's choice of subsequent items from the full item bank (95 items in total) and a T-Score is generated. T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. A higher score reflects higher levels of fatigue.	Baseline, 6 week, 12 week
Magnitude of change in PROMIS Dyspnea scale	Patient-Reported Outcomes Measurement Information System (PROMIS) Dyspnea Severity Computer Adaptive Test (CAT). The PROMIS Dyspnea instruments evaluate a range of self-reported symptoms related to dyspnea. With CAT, participant responses guide the system's choice of subsequent items from the full item bank (33 items in total) and a T-Score is generated. T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. A higher score reflects higher levels of dyspnea.	Baseline, 6 week, 12 week
Autonomic tone	The investigators will estimate autonomic tone of participants by extracting data from implantable cardioverter defibrillator (ICD). Data analyses will consist of heart rate spectral analyses.	Monthly data extraction from ICD: Baseline, week 4, week 8, week 12

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2018
• Primary Completion (Anticipated): May 1, 2019
• Study Completion (Anticipated): May 1, 2019

Study Registration Dates

• First Submitted: January 31, 2018
• First Submitted That Met QC Criteria: February 27, 2018
• First Posted (Actual): February 28, 2018

Study Record Updates

• Last Update Posted (Actual): March 4, 2019
• Last Update Submitted That Met QC Criteria: February 28, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Breathing; Mind-body
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Respiratory Tract Diseases; Respiration Disorders; Heart Failure; Respiratory Aspiration
• Other Study ID Numbers: 171991

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No