Clinical trial NCT03449121: Study for Breathing Interventions in Congestive Heart Failure
Official title: Pilot Study for Breathing Interventions in Congestive Heart Failure
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Congestive Heart Failure
Keywords: Breathing
Mind-body
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2018-02-28
Enrollment: 0
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Feasibility of intervention administration measured by frequency of visits
timeFrame: Weekly for 12 weeks
measure: Feasibility of intervention administration measured by home practice adherence
timeFrame: Weekly for 12 weeks
measure: Feasibility of intervention administration measured by patient satisfaction
timeFrame: One time, at 12 week survey
measure: Safety of yoga practice as measured by occurrence of adverse events
timeFrame: Weekly for 12 weeks
Secondary outcomes:
measure: Magnitude of change in PROMIS Depression scale
timeFrame: Baseline, 6 week, 12 week
measure: Magnitude of change in PROMIS Anxiety scale
timeFrame: Baseline, 6 week, 12 week
measure: Magnitude of change in PROMIS Global Health scale
timeFrame: Baseline, 6 week, 12 week
measure: Magnitude of change in PROMIS Physical Function scale
timeFrame: Baseline, 6 week, 12 week
measure: Magnitude of change in PROMIS Fatigue scale
timeFrame: Baseline, 6 week, 12 week
measure: Magnitude of change in PROMIS Dyspnea scale
timeFrame: Baseline, 6 week, 12 week
measure: Autonomic tone
timeFrame: Monthly data extraction from ICD: Baseline, week 4, week 8, week 12
Other outcomes:
Locations:
Study officials:
References: